Trial Outcomes & Findings for Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3) (NCT NCT03912532)

Last Updated: 2025-07-03

Results Overview

Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

171 participants

Primary outcome timeframe

Baseline up to Week 24

Results posted on

2025-07-03

Participant Flow

A total of 171 participants who met all inclusion criteria and no exclusion criteria were randomized to receive treatment at 37 clinic sites in the United States.

Participant milestones

Participant milestones
Measure	Aldafermin 0.3 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo Participants who were randomized to receive a single subcutaneous injection of placebo.
Overall Study STARTED	43	42	43	43
Overall Study COMPLETED	35	35	37	36
Overall Study NOT COMPLETED	8	7	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Aldafermin 0.3 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo Participants who were randomized to receive a single subcutaneous injection of placebo.
Overall Study Adverse Event	3	3	2	2
Overall Study Lost to Follow-up	3	2	1	2
Overall Study Withdrawal by Subject	1	1	2	0
Overall Study Physician Decision	1	0	0	3
Overall Study Other	0	1	1	0

Baseline Characteristics

Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aldafermin 0.3 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=42 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=43 Participants Participants who were randomized to receive a single subcutaneous injection of placebo.	Total n=171 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	35 Participants n=7 Participants	36 Participants n=5 Participants	35 Participants n=4 Participants	140 Participants n=21 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 11.2 • n=5 Participants	49.8 years STANDARD_DEVIATION 13.2 • n=7 Participants	52.7 years STANDARD_DEVIATION 11.1 • n=5 Participants	53.0 years STANDARD_DEVIATION 10.8 • n=4 Participants	52.5 years STANDARD_DEVIATION 11.6 • n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	29 Participants n=5 Participants	26 Participants n=4 Participants	112 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	17 Participants n=4 Participants	59 Participants n=21 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants	38 Participants n=7 Participants	39 Participants n=5 Participants	41 Participants n=4 Participants	158 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: Liver fibrosis response was assessed in the Intent-to-Treat Analysis Set.

Outcome measures

Outcome measures
Measure	Aldafermin 0.3 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=42 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=43 Participants Participants who were randomized to receive a single subcutaneous injection of placebo.
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	0.24 score on a scale Standard Error 0.04	0.25 score on a scale Standard Error 0.04	0.27 score on a scale Standard Error 0.07	0.23 score on a scale Standard Error 0.06

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: TEAEs were assessed in the Safety Analysis Set.

Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration.

Outcome measures

Outcome measures
Measure	Aldafermin 0.3 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=41 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=43 Participants Participants who were randomized to receive a single subcutaneous injection of placebo.
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE	30 Participants	34 Participants	38 Participants	36 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, Grade 1	11 Participants	12 Participants	17 Participants	10 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, Grade 2	16 Participants	18 Participants	19 Participants	24 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, Grade 3	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, Grade 4	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, Grade 5	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any aldafermin-related TEAE	13 Participants	20 Participants	21 Participants	14 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, not related to aldafermin	17 Participants	14 Participants	17 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, possible related to aldafermin	10 Participants	8 Participants	7 Participants	11 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, probable related to aldafermin	2 Participants	5 Participants	5 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, definite related to aldafermin	1 Participants	7 Participants	9 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any rosuvastatin-related TEAE	13 Participants	4 Participants	9 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, not related to rosuvastatin	17 Participants	30 Participants	29 Participants	28 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, possible related to rosuvastatin	10 Participants	1 Participants	6 Participants	6 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, probable related to rosuvastatin	1 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE, definite related to rosuvastatin	2 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAE leading to study drug withdrawal	3 Participants	4 Participants	3 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any aldafermin-related TEAE leading to study drug withdrawal	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any rosuvastatin-related TEAE leading to study drug withdrawal	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any serious TEAE	1 Participants	4 Participants	1 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Any TEAEs leading to death	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, and Week 30

Population: Mean change in liver fat content was assessed in the Intent-to-Treat Analysis Set.

Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Outcome measures

Outcome measures
Measure	Aldafermin 0.3 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=42 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=43 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=43 Participants Participants who were randomized to receive a single subcutaneous injection of placebo.
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Baseline	19.13 percentage of liver fat content Standard Deviation 7.6	17.40 percentage of liver fat content Standard Deviation 6.4	18.69 percentage of liver fat content Standard Deviation 7.5	17.00 percentage of liver fat content Standard Deviation 6.6
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12	14.43 percentage of liver fat content Standard Deviation 8.8	10.62 percentage of liver fat content Standard Deviation 5.6	7.03 percentage of liver fat content Standard Deviation 5.7	16.00 percentage of liver fat content Standard Deviation 7.1
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24	14.85 percentage of liver fat content Standard Deviation 9.3	10.64 percentage of liver fat content Standard Deviation 6.2	6.72 percentage of liver fat content Standard Deviation 5.6	14.01 percentage of liver fat content Standard Deviation 6.2
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30	16.30 percentage of liver fat content Standard Deviation 9.2	15.36 percentage of liver fat content Standard Deviation 6.5	13.10 percentage of liver fat content Standard Deviation 7.4	14.27 percentage of liver fat content Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline to Week 12, Week 24, and Week 30

Population: Mean change from baseline in liver fat content was assessed in the Intent-to-Treat Analysis Set.

Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content.

Outcome measures

Outcome measures
Measure	Aldafermin 0.3 mg n=38 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=37 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=37 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=39 Participants Participants who were randomized to receive a single subcutaneous injection of placebo.
Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Change from baseline to Week 12	-4.28 percentage of liver fat content Standard Error 0.83	-7.50 percentage of liver fat content Standard Error 0.85	-11.37 percentage of liver fat content Standard Error 0.84	-1.49 percentage of liver fat content Standard Error 0.82
Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Change from baseline to Week 24	-3.73 percentage of liver fat content Standard Error 0.97	-7.35 percentage of liver fat content Standard Error 1.04	-11.37 percentage of liver fat content Standard Error 0.98	-3.44 percentage of liver fat content Standard Error 0.98
Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Mean change from baseline to Week 30	-2.10 percentage of liver fat content Standard Error 1.08	-2.95 percentage of liver fat content Standard Error 1.13	-5.19 percentage of liver fat content Standard Error 1.05	-2.92 percentage of liver fat content Standard Error 1.05

SECONDARY outcome

Timeframe: Baseline to Week 12, Week 24 and Week 30

Population: Liver fat content normalization and response were assessed in participants with available data in the Intent-to-Treat Analysis Set.

Liver fat normalization (LFC; defined as \<5%) and response (LFC decrease \>=5% from baseline and LFC relative decrease \>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\<5%) or response (decrease from baseline \>=5% or relative decrease from baseline \>=30%).

Outcome measures

Outcome measures
Measure	Aldafermin 0.3 mg n=38 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=37 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=37 Participants Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=39 Participants Participants who were randomized to receive a single subcutaneous injection of placebo.
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24: Normalization, No response	33 Participants	29 Participants	17 Participants	35 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24: Decrease >=5%, Response	21 Participants	21 Participants	30 Participants	10 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24: Decrease >=5%, No response	16 Participants	12 Participants	7 Participants	27 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24: Relative decrease >=30%, Response	18 Participants	20 Participants	32 Participants	11 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24: Relative decrease >=30%, No response	19 Participants	13 Participants	5 Participants	26 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30: Normalization, response	4 Participants	1 Participants	4 Participants	4 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30: Normalization, No response	30 Participants	30 Participants	32 Participants	32 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30: Decrease >=5%, Response	8 Participants	12 Participants	15 Participants	9 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30: Decrease >=5%, No response	26 Participants	19 Participants	21 Participants	27 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30: Relative decrease >=30%, Response	10 Participants	11 Participants	16 Participants	10 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 30: Relative decrease >=30%, No response	24 Participants	20 Participants	20 Participants	26 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12: Normalization, response	3 Participants	4 Participants	17 Participants	0 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12: Normalization, No response	35 Participants	33 Participants	20 Participants	39 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12: Decrease >=5%, Response	19 Participants	24 Participants	33 Participants	7 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12: Decrease >=5%, No response	19 Participants	13 Participants	4 Participants	32 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12: Relative decrease >=30%, Response	19 Participants	25 Participants	33 Participants	7 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 12: Relative decrease >=30%, No response	19 Participants	12 Participants	4 Participants	32 Participants
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis Week 24: Normalization, response	4 Participants	4 Participants	20 Participants	2 Participants

Adverse Events

Aldafermin 0.3 mg

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Aldafermin 1.0 mg

Serious events: 4 serious events

Other events: 34 other events

Deaths: 1 deaths

Aldafermin 3.0 mg

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aldafermin 0.3 mg n=43 participants at risk Participants who were randomized to receive a single subcutaneous injection of aldafermin 0.3 mg.	Aldafermin 1.0 mg n=41 participants at risk Participants who were randomized to receive a single subcutaneous injection of aldafermin 1.0 mg.	Aldafermin 3.0 mg n=43 participants at risk Participants who were randomized to receive a single subcutaneous injection of aldafermin 3.0 mg.	Placebo n=43 participants at risk Participants who were randomized to receive a single subcutaneous injection of placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	2.3% 1/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Psychiatric disorders Suicide attempt	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Cardiac disorders Cardiac hypertrophy	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Metabolism and nutrition disorders Obesity	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.4% 1/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.3% 1/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Cardiac disorders Coronary artery disease	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.3% 1/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Congenital, familial and genetic disorders Bronchogenic cyst	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.3% 1/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/41 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	0.00% 0/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.	2.3% 1/43 • Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30. TEAEs defined as AEs that started on or after the date of first study drug dosing. AEs without an onset date were defined as TE, except if an incomplete date (eg, mon/yr) clearly indicated the event started prior to the start of first dose of study drug or if the AE stop date indicated that the event started or stopped prior to the start of first dose of study drug. The at Risk in the Aldafermin 1.0 mg group is 41 from the Safety Analysis Set, and the Intent-to-Treat group is 42.

Other adverse events

Additional Information

VP, Clinical Operations

NGM Biopharmaceuticals, Inc

Phone: 650-243-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place