Trial Outcomes & Findings for Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) (NCT NCT04929483)

Last Updated: 2026-01-06

Results Overview

Nonalcoholic fatty liver disease activity score (NAS) was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). NASH clinical research system (CRN) fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). Worsening of fibrosis was defined as progression of fibrosis greater than or equal to (≥) 1 stage in NASH CRN fibrosis score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

222 participants

Primary outcome timeframe

Week 24

Results posted on

2026-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Main and Extension Study: Pegozafermin 15 mg QW Participants received pegozafermin 15 milligrams (mg) once weekly (QW) as a subcutaneous (SC) injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 30 mg QW Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 44 mg Q2W Participants received pegozafermin 44 mg every 2 weeks (Q2W) as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main Study: Placebo Pooled Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks in the main study.	Main and Extension Study: Placebo (Main) and Placebo (Extension) Only Participants who received placebo QW as a SC injection for 24 weeks in the main study were re-randomized to receive placebo QW as a SC injection for 24 weeks in the extension study. Participants who received placebo Q2W as a SC injection for 24 weeks in the main study continued on placebo Q2W for 24 weeks in the extension study.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Extension Study (24 Weeks) COMPLETED	19	53	42	0	38	19
Extension Study (24 Weeks) NOT COMPLETED	1	3	8	0	4	0
Main Study (24 Weeks) STARTED	21	73	57	71	0	0
Main Study (24 Weeks) Received at Least 1 Dose of Study Drug	21	72	57	69	0	0
Main Study (24 Weeks) Safety Analysis Set	21	72	57	69	0	0
Main Study (24 Weeks) Pharmacokinetic (PK) Analysis Set	14	66	51	0	0	0
Main Study (24 Weeks) MRI-PDFF Analysis Set	14	61	49	57	0	0
Main Study (24 Weeks) Full Analysis Set	14	66	51	61	0	0
Main Study (24 Weeks) COMPLETED	20	59	51	63	0	0
Main Study (24 Weeks) NOT COMPLETED	1	14	6	8	0	0
Extension Study (24 Weeks) STARTED	20	56	50	0	42	19
Extension Study (24 Weeks) Received at Least 1 Dose of Study Drug	20	56	48	0	42	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Main and Extension Study: Pegozafermin 15 mg QW Participants received pegozafermin 15 milligrams (mg) once weekly (QW) as a subcutaneous (SC) injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 30 mg QW Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 44 mg Q2W Participants received pegozafermin 44 mg every 2 weeks (Q2W) as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main Study: Placebo Pooled Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks in the main study.	Main and Extension Study: Placebo (Main) and Placebo (Extension) Only Participants who received placebo QW as a SC injection for 24 weeks in the main study were re-randomized to receive placebo QW as a SC injection for 24 weeks in the extension study. Participants who received placebo Q2W as a SC injection for 24 weeks in the main study continued on placebo Q2W for 24 weeks in the extension study.
Main Study (24 Weeks) Adverse Event	1	6	2	1	0
Main Study (24 Weeks) Withdrawal by Subject	0	3	3	3	0
Main Study (24 Weeks) Lost to Follow-up	0	2	0	2	0
Main Study (24 Weeks) Physician Decision	0	2	0	0	0
Main Study (24 Weeks) Protocol Violation	0	0	1	0	0
Main Study (24 Weeks) Randomized in error	0	1	0	2	0
Extension Study (24 Weeks) Withdrawal by Subject	0	0	3	0	2
Extension Study (24 Weeks) Lost to Follow-up	0	1	1	0	1
Extension Study (24 Weeks) Other than specified	1	0	1	0	1
Extension Study (24 Weeks) Adverse Event	0	2	3	0	0

Baseline Characteristics

Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main and Extension Study: Pegozafermin 15 mg QW n=21 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 30 mg QW n=73 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 44 mg Q2W n=57 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main Study: Placebo Pooled n=71 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks in the main study.	Total n=222 Participants Total of all reporting groups
Age, Continuous	55.0 years STANDARD_DEVIATION 10.45 • n=37 Participants	55.3 years STANDARD_DEVIATION 11.15 • n=56 Participants	55.2 years STANDARD_DEVIATION 11.23 • n=82 Participants	56.3 years STANDARD_DEVIATION 9.01 • n=31 Participants	55.6 years STANDARD_DEVIATION 10.41 • n=5 Participants
Sex: Female, Male Female	9 Participants n=37 Participants	50 Participants n=56 Participants	20 Participants n=82 Participants	39 Participants n=31 Participants	118 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=37 Participants	23 Participants n=56 Participants	37 Participants n=82 Participants	32 Participants n=31 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=37 Participants	32 Participants n=56 Participants	20 Participants n=82 Participants	24 Participants n=31 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=37 Participants	41 Participants n=56 Participants	37 Participants n=82 Participants	47 Participants n=31 Participants	137 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants	0 Participants n=31 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants	1 Participants n=31 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=37 Participants	1 Participants n=56 Participants	1 Participants n=82 Participants	1 Participants n=31 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	1 Participants n=82 Participants	0 Participants n=31 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	3 Participants n=56 Participants	0 Participants n=82 Participants	0 Participants n=31 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=37 Participants	69 Participants n=56 Participants	54 Participants n=82 Participants	67 Participants n=31 Participants	208 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants	1 Participants n=31 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	0 Participants n=56 Participants	1 Participants n=82 Participants	1 Participants n=31 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Full analysis set (FAS) included all enrolled participants with confirmed fibrosis stage F2 or F3 and NAS ≥4 at baseline per independent review by a 3-pathologist panel who were eligible and assigned a randomization number in the study and received at least 1 dose of investigational product (IP). Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=53 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=43 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=54 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis	5 Participants	12 Participants	11 Participants	1 Participants	—

PRIMARY outcome

Timeframe: Week 24

Population: FAS included all enrolled participants with confirmed fibrosis stage F2 or F3 and NAS ≥4 at baseline per independent review by a 3-pathologist panel who were eligible and assigned a randomization number in the study and received at least 1 dose of IP. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.

Worsening of NASH was defined as increase in nonalcoholic fatty liver disease activity score (NAS) for ballooning, inflammation, or steatosis. NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. NASH CRN fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=53 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=43 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=54 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Number of Participants Who Achieved Improvement of Fibrosis ≥1 Stage Without Worsening of NASH	3 Participants	14 Participants	11 Participants	4 Participants	—

SECONDARY outcome

Timeframe: Week 24

NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Worsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH CRN fibrosis score. NASH CRN fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=53 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=43 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=54 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Number of Participants With at Least a 2-Point Improvement in NAS and no Worsening of Fibrosis	5 Participants	34 Participants	26 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Week 24

NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score. NASH CRN fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=53 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=43 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=54 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Number of Participants With NASH Resolution and Fibrosis Improvement ≥1 Stage	2 Participants	7 Participants	8 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 24

A responder was defined as achieving ≥2 point improvement in NAS score and are MRI-PDFF responders and ALT responders at Week 24. NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. MRI-PDFF responder was defined as ≥30% reduction from baseline in liver fat by MRI-PDFF. ALT responder was defined as ≥17 units/liter (U/L) or ≥30% reduction from baseline in ALT.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=53 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=43 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=54 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Number of Participants With at Least a 2-point Improvement in NAS Score and Are Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) Responders and Alanine Aminotransferase (ALT) Responders	4 Participants	31 Participants	22 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=12 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=57 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=45 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=57 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in Serum Triglycerides	-5.79 Percent change Standard Deviation 19.473	-14.87 Percent change Standard Deviation 54.765	-7.79 Percent change Standard Deviation 29.612	1.02 Percent change Standard Deviation 31.425	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=11 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=55 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=44 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=56 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-c)	20.28 Percent change Standard Deviation 74.840	-0.42 Percent change Standard Deviation 35.290	-5.64 Percent change Standard Deviation 31.944	0.32 Percent change Standard Deviation 30.811	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=12 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=57 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=45 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=57 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-c)	-3.04 Percent change Standard Deviation 18.421	-6.94 Percent change Standard Deviation 21.260	-6.95 Percent change Standard Deviation 24.120	-0.46 Percent change Standard Deviation 24.081	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=12 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=57 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=45 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=57 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-c)	4.69 Percent change Standard Deviation 13.441	15.82 Percent change Standard Deviation 20.376	7.31 Percent change Standard Deviation 18.690	-2.01 Percent change Standard Deviation 13.592	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=13 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=56 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=46 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=57 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in Adiponectin	22.73 Percent change Standard Deviation 44.045	31.36 Percent change Standard Deviation 49.215	26.60 Percent change Standard Deviation 46.353	-6.28 Percent change Standard Deviation 23.770	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=57 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=45 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=56 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in HbA1c (Glycated Hemoglobin)	-2.24 Percent change Standard Deviation 13.039	-3.74 Percent change Standard Deviation 11.216	-2.00 Percent change Standard Deviation 11.742	-0.52 Percent change Standard Deviation 9.012	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=61 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=47 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=57 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in Alanine Transaminase Change at Week 12	-39.68 Percent change Standard Deviation 33.615	-42.04 Percent change Standard Deviation 23.044	-35.42 Percent change Standard Deviation 28.874	-8.62 Percent change Standard Deviation 35.051	—
Main Study: Percent Change From Baseline in Alanine Transaminase Change at Week 24	-39.28 Percent change Standard Deviation 31.478	-42.73 Percent change Standard Deviation 25.218	-31.33 Percent change Standard Deviation 43.053	-0.41 Percent change Standard Deviation 48.798	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and 24

Population: MRI-PDFF analysis set included all participants in the FAS who had a baseline and at least one follow-up MRI-PDFF assessment. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified time points.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=61 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=49 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=57 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF) Change at Week 12	-45.05 Percent Change Standard Deviation 25.857	-57.07 Percent Change Standard Deviation 19.563	-50.63 Percent Change Standard Deviation 21.225	-0.53 Percent Change Standard Deviation 42.062	—
Main Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF) Change at Week 24	-27.92 Percent Change Standard Deviation 35.209	-51.05 Percent Change Standard Deviation 24.065	-42.90 Percent Change Standard Deviation 40.257	-5.80 Percent Change Standard Deviation 47.605	—

SECONDARY outcome

Timeframe: Baseline, Week 12 and 24

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=13 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=62 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=49 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=55 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3) Change at Week 12	-35.34 Percent Change Standard Deviation 26.673	-9.51 Percent Change Standard Deviation 37.151	-13.84 Percent Change Standard Deviation 25.420	10.57 Percent Change Standard Deviation 33.392	—
Main Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3) Change at Week 24	-17.10 Percent Change Standard Deviation 34.345	-17.76 Percent Change Standard Deviation 28.250	-15.22 Percent Change Standard Deviation 27.429	9.46 Percent Change Standard Deviation 45.403	—

SECONDARY outcome

Timeframe: Predose at Week 12 and 24

Population: Pharmacokinetic analysis set included all participants in the FAS who had sufficient data to adequately characterize the trough serum pegozafermin concentrations and had no other events or protocol violations that would adversely affect results, such as not completing the full dose. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for specified time points.

Serum trough concentration (ng/mL) of pegozafermin taken from pre-dose samples.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=13 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=50 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=36 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main Study: Trough Serum Concentration of Pegozafermin Week 12	197.833 nanograms/milliliter Standard Deviation 110.097	534.289 nanograms/milliliter Standard Deviation 375.149	81.699 nanograms/milliliter Standard Deviation 77.099	—	—
Main Study: Trough Serum Concentration of Pegozafermin Week 24	168.127 nanograms/milliliter Standard Deviation 158.749	691.424 nanograms/milliliter Standard Deviation 718.495	84.033 nanograms/milliliter Standard Deviation 77.896	—	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Baseline was prior to dosing on Day 1 of the main study.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=14 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=48 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=38 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=32 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) n=19 Participants Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main and Extension Study: Percent Change From Baseline in Alanine Transaminase	-28.51 Percent change Standard Deviation 37.164	-45.08 Percent change Standard Deviation 25.068	-38.05 Percent change Standard Deviation 28.256	-5.03 Percent change Standard Deviation 43.918	-31.71 Percent change Standard Deviation 46.868

SECONDARY outcome

Timeframe: Baseline, Week 48

Baseline was prior to dosing on Day 1 of the main study.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=13 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=47 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=37 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=32 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) n=18 Participants Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main and Extension Study: Percent Change From Baseline in N-Terminal Type III Collagen Propeptide (Pro-C3)	-7.89 Percent Change Standard Deviation 21.069	-16.82 Percent Change Standard Deviation 23.675	-14.96 Percent Change Standard Deviation 21.342	1.64 Percent Change Standard Deviation 33.082	-17.22 Percent Change Standard Deviation 23.053

SECONDARY outcome

Timeframe: Baseline, Week 48

Baseline was prior to dosing on Day 1 of the main study.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=13 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=48 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=40 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=32 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) n=19 Participants Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main and Extension Study: Percent Change From Baseline in Hepatic Fat Fraction By Magnetic Resonance Imaging - (MRI-PDFF)	-23.93 Percent Change Standard Deviation 33.557	-48.75 Percent Change Standard Deviation 29.717	-25.93 Percent Change Standard Deviation 50.980	-3.15 Percent Change Standard Deviation 47.992	-59.14 Percent Change Standard Deviation 25.807

SECONDARY outcome

Timeframe: Predose at Week 48

Serum trough concentration (ng/mL) of pegozafermin taken from pre-dose samples.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=10 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=35 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=25 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=10 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Main and Extension Study: Trough Serum Concentration of Pegozafermin	206.54 nanograms/milliliter Standard Deviation 93.104	471.28 nanograms/milliliter Standard Deviation 397.691	111.00 nanograms/milliliter Standard Deviation 88.644	553.45 nanograms/milliliter Standard Deviation 651.882	—

SECONDARY outcome

Timeframe: Baseline up to Week 51

Population: Safety analysis set included all randomized participants who received at least 1 dose of IP.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of IP, whether or not considered related to the IP. TEAEs were defined as AEs that started or worsened on or after the first dose of study IP up to Week 51. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, important medical event or reaction. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Outcome measures
Measure	Main Study: Pegozafermin 15 mg QW n=21 Participants Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 30 mg QW n=72 Participants Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks.	Main Study: Pegozafermin 44 mg Q2W n=57 Participants Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks.	Main Study: Placebo Pooled n=50 Participants Participants received placebo matched to pegozafermin QW or Q2W as a SC injection for 24 weeks.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) n=19 Participants Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	21 Participants	63 Participants	46 Participants	42 Participants	17 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	1 Participants	5 Participants	8 Participants	6 Participants	2 Participants

Adverse Events

Main and Extension Study: Pegozafermin 15 mg QW

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Main and Extension Study: Pegozafermin 30 mg QW

Serious events: 5 serious events

Other events: 62 other events

Deaths: 0 deaths

Main and Extension Study: Pegozafermin 44 mg Q2W

Serious events: 8 serious events

Other events: 45 other events

Deaths: 0 deaths

Main and Extension Study: Placebo (Main) and Placebo (Extension) Only

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension)

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main and Extension Study: Pegozafermin 15 mg QW n=21 participants at risk Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 30 mg QW n=72 participants at risk Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 44 mg Q2W n=57 participants at risk Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Placebo (Main) and Placebo (Extension) Only n=50 participants at risk Participants who received placebo QW as a SC injection for 24 weeks in the main study were re-randomized to receive placebo QW as a SC injection for 24 weeks in the extension study. Participants who received placebo Q2W as a SC injection for 24 weeks in the main study continued on placebo Q2W for 24 weeks in the extension study.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) n=19 participants at risk Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
General disorders Non-cardiac chest pain	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Hepatobiliary disorders Cholecystitis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Hepatobiliary disorders Liver injury	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Pyelonephritis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations COVID-19	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Pneumonia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Nervous system disorders Brain stem haemorrhage	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Nervous system disorders Lumbar radiculopathy	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Nervous system disorders Spinal claudication	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Cardiac disorders Angina pectoris	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Cardiac disorders Diastolic dysfunction	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Cardiac disorders Myocardial infarction	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Cardiac disorders Supraventricular tachycardia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Eye disorders Blepharitis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Pancreatitis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Pancreatitis acute	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Depression	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Mental disorder	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Mental status changes	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Suicide attempt	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Vascular disorders Thrombophlebitis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Vascular disorders Thrombophlebitis superficial	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.

Other adverse events

Other adverse events
Measure	Main and Extension Study: Pegozafermin 15 mg QW n=21 participants at risk Participants received pegozafermin 15 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 30 mg QW n=72 participants at risk Participants received pegozafermin 30 mg QW as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Pegozafermin 44 mg Q2W n=57 participants at risk Participants received pegozafermin 44 mg Q2W as a SC injection for 24 weeks in the main study and for 24 weeks in the extension study.	Main and Extension Study: Placebo (Main) and Placebo (Extension) Only n=50 participants at risk Participants who received placebo QW as a SC injection for 24 weeks in the main study were re-randomized to receive placebo QW as a SC injection for 24 weeks in the extension study. Participants who received placebo Q2W as a SC injection for 24 weeks in the main study continued on placebo Q2W for 24 weeks in the extension study.	Main and Extension Study: Placebo (Main) and Pegozafermin 30 mg QW (Extension) n=19 participants at risk Participants who received placebo QW in the main study were re-randomized to receive pegozafermin 30 mg QW as a SC injection for 24 weeks in the extension study.
General disorders Pyrexia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.2% 3/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Endocrine disorders Hypogonadism	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Abdominal distension	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.9% 5/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.0% 5/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Abdominal pain	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	11.1% 8/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	8.0% 4/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Abdominal pain lower	14.3% 3/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Abdominal pain upper	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.2% 3/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.0% 5/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Constipation	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.9% 5/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.0% 3/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Diarrhoea	23.8% 5/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	25.0% 18/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	15.8% 9/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.0% 5/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Dry mouth	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.6% 4/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.9% 5/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Nausea	23.8% 5/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	36.1% 26/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	19.3% 11/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.0% 5/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	26.3% 5/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Gastrointestinal disorders Vomiting	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	18.1% 13/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Influenza like illness	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Injection site bruising	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.6% 4/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.0% 5/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Injection site erythema	14.3% 3/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	15.3% 11/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.0% 3/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Injection site pain	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Injection site pruritus	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	8.3% 6/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	21.1% 4/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Injection site rash	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	9.7% 7/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
General disorders Vaccination site joint pain	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations COVID-19	19.0% 4/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	19.4% 14/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	14.0% 8/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	18.0% 9/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	15.8% 3/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Ear infection	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Influenza	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Pharyngitis streptococcal	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Sinusitis	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.6% 4/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	14.0% 8/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Tooth infection	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.8% 2/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Upper respiratory tract infection	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.8% 2/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Infections and infestations Urinary tract infection	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	13.9% 10/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	8.0% 4/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Fall	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.0% 3/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Procedural pain	19.0% 4/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Anxiety	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Investigations Cortisol increased	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.0% 3/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Investigations SARS-CoV-2 test positive	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.9% 5/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Hyperglycaemia	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.8% 2/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Increased appetite	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	15.3% 11/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	7.0% 4/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 3/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.2% 3/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Musculoskeletal and connective tissue disorders Back pain	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.9% 5/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	8.0% 4/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Musculoskeletal and connective tissue disorders Muscle spasms	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	9.7% 7/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Musculoskeletal and connective tissue disorders Osteopenia	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.9% 5/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Nervous system disorders Dizziness	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.8% 2/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Nervous system disorders Headache	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	8.3% 6/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 6/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	6.0% 3/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	21.1% 4/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Nervous system disorders Tension headache	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Renal and urinary disorders Dysuria	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Renal and urinary disorders Proteinuria	9.5% 2/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	10.5% 2/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.6% 4/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.0% 2/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	4.2% 3/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.4% 1/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 3/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.0% 1/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	1.8% 1/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Vascular disorders Hypertension	19.0% 4/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	2.8% 2/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	3.5% 2/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.
Vascular disorders Hypertensive urgency	0.00% 0/21 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/72 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/57 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	0.00% 0/50 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.	5.3% 1/19 • Baseline up to Week 51 Safety analysis set included all randomized participants who received at least 1 dose of IP. As pre-specified, data for the placebo arm was combined for the main and extension study.

Additional Information

Clinical Director

89bio, Inc.

Phone: 1-858-261-8838

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place