Trial Outcomes & Findings for Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia (NCT NCT04541186)

NCT ID: NCT04541186

Last Updated: 2024-07-25

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2024-07-25

Participant Flow

As per the Statistical Analysis Plan (SAP), since a low number of participants enrolled in the fibrate cohort (3 on placebo and 3 on active treatment \[pegozafermin\]), participants in the pegozafermin 27 mg QW fibrate cohort were combined with the pegozafermin 27 mg QW main cohort, forming a pooled pegozafermin 27 mg QW group for analyses. Similarly, the placebo participants in the fibrate cohort were combined with the main placebo group (pooled) for analyses.

Participant milestones

Participant milestones
Measure
Pegozafermin 9 mg QW
Pegozafermin 9 mg QW was administered as a subcutaneous (SC) injection.
Pegozafermin 18 mg QW
Pegozafermin 18 mg QW was administered as an SC injection.
Pegozafermin 27 mg QW
Pegozafermin 27 mg QW was administered as an SC injection.
Pegozafermin 36 mg Q2W
Pegozafermin 36 mg Q2W was administered as an SC injection.
Placebo
Matching placebo was injected at matching frequency per assigned cohort.
Main Study
STARTED
16
17
16
16
15
Main Study
Safety Analysis Set
12
21
15
16
15
Main Study
Full Analysis Set (FAS)
16
17
13
16
14
Main Study
COMPLETED
15
16
10
15
14
Main Study
NOT COMPLETED
1
1
6
1
1
Fibrate Expansion Study
STARTED
0
0
3
0
3
Fibrate Expansion Study
Received at Least 1 Dose of Study Drug
0
0
3
0
3
Fibrate Expansion Study
Full Analysis Set
0
0
3
0
3
Fibrate Expansion Study
COMPLETED
0
0
3
0
2
Fibrate Expansion Study
NOT COMPLETED
0
0
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Pegozafermin 9 mg QW
Pegozafermin 9 mg QW was administered as a subcutaneous (SC) injection.
Pegozafermin 18 mg QW
Pegozafermin 18 mg QW was administered as an SC injection.
Pegozafermin 27 mg QW
Pegozafermin 27 mg QW was administered as an SC injection.
Pegozafermin 36 mg Q2W
Pegozafermin 36 mg Q2W was administered as an SC injection.
Placebo
Matching placebo was injected at matching frequency per assigned cohort.
Main Study
Adverse Event
0
0
4
0
0
Main Study
Investigator Decision
0
0
1
1
0
Main Study
Withdrawal by Subject
1
1
0
0
0
Main Study
COVID-19-related Dose Interruption
0
0
0
0
1
Main Study
Randomized in Error Not Treated
0
0
1
0
0
Fibrate Expansion Study
Other than Specified
0
0
0
0
1

Baseline Characteristics

Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pegozafermin 9 mg QW
n=12 Participants
Pegozafermin 9 mg QW was administered as a SC injection.
Pegozafermin 18 mg QW
n=21 Participants
Pegozafermin 18 mg QW was administered as an SC injection.
Pegozafermin 27 mg QW
n=18 Participants
Pegozafermin 27 mg QW was administered as an SC injection. The Main Study cohort and Fibrate Expansion cohort for pegozafermin 27 mg were pooled together due to low sample size in the expansion cohort.
Pegozafermin 36 mg Q2W
n=16 Participants
Pegozafermin 36 mg Q2W was administered as an SC injection.
Placebo
n=18 Participants
Matching placebo was injected at matching frequency per assigned cohort. Main Study cohort and Fibrate Expansion cohort for placebo were pooled together due to low sample size in the expansion cohort.
Total
n=85 Participants
Total of all reporting groups
Age, Continuous
52.8 years
STANDARD_DEVIATION 14.12 • n=5 Participants
51.3 years
STANDARD_DEVIATION 10.81 • n=7 Participants
53.9 years
STANDARD_DEVIATION 7.18 • n=5 Participants
53.1 years
STANDARD_DEVIATION 12.36 • n=4 Participants
57.5 years
STANDARD_DEVIATION 10.30 • n=21 Participants
53.7 years
STANDARD_DEVIATION 10.86 • n=8 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
2 Participants
n=4 Participants
6 Participants
n=21 Participants
21 Participants
n=8 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
17 Participants
n=7 Participants
13 Participants
n=5 Participants
14 Participants
n=4 Participants
12 Participants
n=21 Participants
64 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
3 Participants
n=21 Participants
17 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
19 Participants
n=7 Participants
14 Participants
n=5 Participants
11 Participants
n=4 Participants
15 Participants
n=21 Participants
68 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · Black
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · White
11 Participants
n=5 Participants
21 Participants
n=7 Participants
18 Participants
n=5 Participants
14 Participants
n=4 Participants
17 Participants
n=21 Participants
81 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Race/Ethnicity, Customized
Race · Unknown
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
Triglyceride (TG) Level
<750 mg/dL
9 Participants
n=5 Participants
14 Participants
n=7 Participants
12 Participants
n=5 Participants
9 Participants
n=4 Participants
13 Participants
n=21 Participants
57 Participants
n=8 Participants
Triglyceride (TG) Level
≥750 mg/dL
3 Participants
n=5 Participants
7 Participants
n=7 Participants
6 Participants
n=5 Participants
7 Participants
n=4 Participants
5 Participants
n=21 Participants
28 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Outcome measures

Outcome measures
Measure
Pegozafermin
n=64 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=17 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change From Baseline to Week 8 in Serum Triglyceride (TG)
-57.33 percent change from Baseline
Interval -69.07 to -32.31
-11.85 percent change from Baseline
Interval -23.22 to 7.88

SECONDARY outcome

Timeframe: Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Outcome measures

Outcome measures
Measure
Pegozafermin
n=64 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=17 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Number of Participants Who Achieved TG <500 mg/dL at Week 8
51 Participants
5 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Least Squares Means were calculated using mixed-model repeated measures (MMRM).

Outcome measures

Outcome measures
Measure
Pegozafermin
n=63 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=17 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C)
Non-HDL-C
-18.29 percent change from Baseline
Standard Error 2.943
-0.57 percent change from Baseline
Standard Error 5.586
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C)
ApoB
-10.51 percent change from Baseline
Standard Error 2.238
1.07 percent change from Baseline
Standard Error 4.309
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C)
LDL-C
10.44 percent change from Baseline
Standard Error 4.654
8.72 percent change from Baseline
Standard Error 9.018
Percent Change From Baseline to Week 8 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B100 (ApoB), Low-density Lipoprotein Cholesterol (LDL-C), and High-density Lipoprotein Cholesterol (HDL-C)
HDL-C
24.65 percent change from Baseline
Standard Error 3.752
9.67 percent change from Baseline
Standard Error 7.045

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Outcome measures

Outcome measures
Measure
Pegozafermin
n=62 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=15 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG
VLDL-C
-47.96 percent change from Baseline
Interval -63.14 to -16.67
-0.41 percent change from Baseline
Interval -30.38 to 10.98
Percent Change From Baseline to Week 8 in Very Low-density Lipoprotein Cholesterol (VLDL-C) and VLDL-TG
VLDL-TG
-58.50 percent change from Baseline
Interval -72.53 to -32.8
-0.85 percent change from Baseline
Interval -27.72 to 14.25

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Least Squares Mean was calculated using MMRM.

Outcome measures

Outcome measures
Measure
Pegozafermin
n=63 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=17 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight
Fasting Plasma Glucose
-3.90 percent change from Baseline
Standard Error 2.681
-2.67 percent change from Baseline
Standard Error 5.230
Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight
Adiponectin
69.53 percent change from Baseline
Standard Error 7.383
5.70 percent change from Baseline
Standard Error 14.556
Percent Change in Baseline to Week 8 in Fasting Plasma Glucose, Adiponectin, and Body Weight
Body Weight
-0.15 percent change from Baseline
Standard Error 0.339
-0.14 percent change from Baseline
Standard Error 0.654

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: All participants in the FAS who had baseline and a follow-up MRI-PDFF assessment. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Least Squares Mean was calculated using analysis of covariance (ANCOVA).

Outcome measures

Outcome measures
Measure
Pegozafermin
n=17 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=6 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change From Baseline to Week 8 in Liver Fat as Assessed by Magnetic Resonance Imaging - Whole Liver Proton Density Fat Fraction (MRI-PDFF)
-42.18 percent change from Baseline
Standard Error 6.207
-8.26 percent change from Baseline
Standard Error 11.214

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Outcome measures

Outcome measures
Measure
Pegozafermin
n=63 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=17 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change From Baseline to Week 8 in High-sensitivity C-reactive Protein (hsCRP)
-21.43 percent change from Baseline
Interval -43.3 to 42.37
-1.10 percent change from Baseline
Interval -50.41 to 18.84

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: FAS: Participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TG measurement not including EOS visit. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified in the SAP, the sample size in each arm (by dose group) was insufficient (under powered) to effectively evaluate differences in efficacy by dose, therefore, efficacy analysis was performed using total pegozafermin and placebo groups.

Least Squares Mean was calculated using MMRM.

Outcome measures

Outcome measures
Measure
Pegozafermin
n=63 Participants
All participants who were randomized to pegozafermin in the main study and fibrate expansion cohort were pooled together.
Placebo
n=17 Participants
Participants randomized to placebo in the main study and fibrate expansion cohort were pooled together.
Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT
-4.28 percent change from Baseline
Standard Error 4.549
0.43 percent change from Baseline
Standard Error 8.881
Percent Change From Baseline to Week 8 in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST
-11.50 percent change from Baseline
Standard Error 3.341
0.51 percent change from Baseline
Standard Error 6.597

Adverse Events

Pegozafermin 9 mg QW

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Pegozafermin 18 mg QW

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Pegozafermin 27 mg QW

Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths

Pegozafermin 36 mg Q2W

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Pegozafermin 9 mg QW
n=12 participants at risk
Pegozafermin 9 mg QW was administered as a SC injection.
Pegozafermin 18 mg QW
n=21 participants at risk
Pegozafermin 18 mg QW was administered as an SC injection.
Pegozafermin 27 mg QW
n=18 participants at risk
Pegozafermin 27 mg QW was administered as an SC injection. The Main Study cohort and Fibrate Expansion cohort for pegozafermin 27 mg were pooled together due to low sample size in the expansion cohort.
Pegozafermin 36 mg Q2W
n=16 participants at risk
Pegozafermin 36 mg Q2W was administered as an SC injection.
Placebo
n=18 participants at risk
Matching placebo was injected at matching frequency per assigned cohort. Main Study cohort and Fibrate Expansion cohort for placebo were pooled together due to low sample size in the expansion cohort.
Vascular disorders
Hypertension
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.

Other adverse events

Other adverse events
Measure
Pegozafermin 9 mg QW
n=12 participants at risk
Pegozafermin 9 mg QW was administered as a SC injection.
Pegozafermin 18 mg QW
n=21 participants at risk
Pegozafermin 18 mg QW was administered as an SC injection.
Pegozafermin 27 mg QW
n=18 participants at risk
Pegozafermin 27 mg QW was administered as an SC injection. The Main Study cohort and Fibrate Expansion cohort for pegozafermin 27 mg were pooled together due to low sample size in the expansion cohort.
Pegozafermin 36 mg Q2W
n=16 participants at risk
Pegozafermin 36 mg Q2W was administered as an SC injection.
Placebo
n=18 participants at risk
Matching placebo was injected at matching frequency per assigned cohort. Main Study cohort and Fibrate Expansion cohort for placebo were pooled together due to low sample size in the expansion cohort.
Endocrine disorders
Hyperthyroidism
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Cardiac disorders
Atrioventricular block first degree
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Cardiac disorders
Supraventricular extrasystoles
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Injection site reaction
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
9.5%
2/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
12.5%
2/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Injection site erythema
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
11.1%
2/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Injection site pruritus
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
9.5%
2/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
COVID-19
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
14.3%
3/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
16.7%
3/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Blood and lymphatic system disorders
Anaemia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Blood and lymphatic system disorders
Lymphadenitis
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Abdominal pain
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
11.1%
2/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Diarrhoea
16.7%
2/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
22.2%
4/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Diverticulum
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Inguinal hernia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Nausea
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
27.8%
5/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
12.5%
2/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Gastrointestinal disorders
Vomiting
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Fatigue
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
11.1%
2/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Injection site bruising
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Injection site induration
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Injection site pain
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
General disorders
Pyrexia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
Gastroenteritis
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
Otitis media
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
Respiratory tract infection viral
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
Sinusitis
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
Urinary tract infection
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Infections and infestations
Viral upper respiratory tract infection
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Injury, poisoning and procedural complications
Contusion
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Injury, poisoning and procedural complications
Corneal abrasion
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Investigations
Blood creatine phosphokinase increased
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Investigations
Blood thyroid stimulating hormone increased
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Investigations
C-reactive protein increased
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Metabolism and nutrition disorders
Increased appetite
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
11.1%
2/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Nervous system disorders
Dizziness
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Nervous system disorders
Dysgeusia
8.3%
1/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Nervous system disorders
Headache
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
11.1%
2/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Nervous system disorders
Paraesthesia
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Nervous system disorders
Taste disorder
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
4.8%
1/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Skin and subcutaneous tissue disorders
Pigmentation disorder
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Vascular disorders
Hypertension
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
6.2%
1/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
Vascular disorders
Lymphoedema
0.00%
0/12 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/21 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
0.00%
0/16 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.
5.6%
1/18 • Day 1 (after dosing) up to 12 weeks
As per the SAP, since a low number of participants enrolled in the fibrate cohort, participants in the pegozafermin 27 mg QW fibrate cohort were pooled with the pegozafermin 27 mg QW main cohort. Similarly, placebo groups in main and fibrate cohorts were pooled. Safety Analysis Set: Participants who received at least 1 dose of study drug. Safety data analysis was by treatment group received. 4 participants randomized to receive 9 mg QW received 18 mg QW instead.

Additional Information

Entrigue Study Team

89bio, Inc.

Phone: 1-415-432-9270

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place