Trial · NCT03912532

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)

NCT03912532, Phase 2, Completed, NGM Biopharmaceuticals, Inc; results first posted 2025-07-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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). Trials, record NCT03912532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03912532

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT03912532
Status: Completed
Phases: Phase 2
Enrollment: 171 participants, actual
Lead sponsor: NGM Biopharmaceuticals, Inc
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: NGM282, Placebo
First posted: 2019-04-11
Last updated: 2025-07-03
Results first posted: 2025-07-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline up to Week 24	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.
Primary	Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline up to Week 24	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.
Secondary	Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline, Week 12, Week 24, and Week 30	Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).
Secondary	Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline to Week 12, Week 24, and Week 30	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.
Secondary	Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline to Week 12, Week 24 and Week 30	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%).

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline up to Week 24	Liver fibrosis response was assessed in the Intent-to-Treat Analysis Set.	score on a scale	MEAN
PRIMARY	Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline up to Week 24	TEAEs were assessed in the Safety Analysis Set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline, Week 12, Week 24, and Week 30	Mean change in liver fat content was assessed in the Intent-to-Treat Analysis Set.	percentage of liver fat content	MEAN
SECONDARY	Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline to Week 12, Week 24, and Week 30	Mean change from baseline in liver fat content was assessed in the Intent-to-Treat Analysis Set.	percentage of liver fat content	MEAN
SECONDARY	Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Baseline to Week 12, Week 24 and Week 30	Liver fat content normalization and response were assessed in participants with available data in the Intent-to-Treat Analysis Set.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group188

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 0.3 mg		0.24	Standard Error 0.04	score on a scale
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 1.0 mg		0.25	Standard Error 0.04	score on a scale
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 3.0 mg		0.27	Standard Error 0.07	score on a scale
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Placebo		0.23	Standard Error 0.06	score on a scale
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 0.3 mg	Any TEAE	30		Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 1.0 mg	Any TEAE	34		Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 3.0 mg	Any TEAE	38		Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Placebo	Any TEAE	36		Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 0.3 mg	Any TEAE, Grade 1	11		Participants
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis	Aldafermin 1.0 mg	Any TEAE, Grade 1	12		Participants

1 to 10 of 188Source ClinicalTrials.gov

See all 188 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aldafermin 0.3 mg	43
Overall Study	STARTED	Aldafermin 1.0 mg	42
Overall Study	STARTED	Aldafermin 3.0 mg	43
Overall Study	STARTED	Placebo	43
Overall Study	COMPLETED	Aldafermin 0.3 mg	35
Overall Study	COMPLETED	Aldafermin 1.0 mg	35
Overall Study	COMPLETED	Aldafermin 3.0 mg	37
Overall Study	COMPLETED	Placebo	36
Overall Study	NOT COMPLETED	Aldafermin 0.3 mg	8
Overall Study	NOT COMPLETED	Aldafermin 1.0 mg	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events144

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal distension	Gastrointestinal disorders	Aldafermin 0.3 mg	2	43
other	Abdominal distension	Gastrointestinal disorders	Aldafermin 1.0 mg	2	41
other	Abdominal distension	Gastrointestinal disorders	Aldafermin 3.0 mg	4	43
other	Abdominal distension	Gastrointestinal disorders	Placebo	1	43
other	Abdominal pain	Gastrointestinal disorders	Aldafermin 0.3 mg	2	43
other	Abdominal pain	Gastrointestinal disorders	Aldafermin 1.0 mg	3	41
other	Abdominal pain	Gastrointestinal disorders	Aldafermin 3.0 mg	3	43
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	43
other	Abdominal pain upper	Gastrointestinal disorders	Aldafermin 0.3 mg	5	43
other	Abdominal pain upper	Gastrointestinal disorders	Aldafermin 1.0 mg	3	41

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aldafermin 0.3 mg	0	43
Total, all-cause mortality	Aldafermin 1.0 mg	1	41
Total, all-cause mortality	Aldafermin 3.0 mg	0	43
Total, all-cause mortality	Placebo	0	43
Total, other adverse events	Aldafermin 0.3 mg	30	43
Total, other adverse events	Aldafermin 1.0 mg	34	41
Total, other adverse events	Aldafermin 3.0 mg	38	43
Total, other adverse events	Placebo	36	43
Total, serious adverse events	Aldafermin 0.3 mg	1	43
Total, serious adverse events	Aldafermin 1.0 mg	4	41

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35325622	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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