Trial · NCT04210245

Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)

NCT04210245, Phase 2, Completed, NGM Biopharmaceuticals, Inc; results first posted 2025-03-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4). Trials, record NCT04210245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04210245

On this page

Trial

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

Title: Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
NCT number: NCT04210245
Status: Completed
Phases: Phase 2
Enrollment: 160 participants, actual
Lead sponsor: NGM Biopharmaceuticals, Inc
Conditions: Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Interventions: aldafermin, Placebo
First posted: 2019-12-24
Last updated: 2025-03-26
Results first posted: 2025-03-26

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	48 weeks	Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	48 weeks	Enrollment to the 0.3 mg dose treatment arm was terminated during the study.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	Daily 0.3 mg Dose	-0.071	Standard Deviation 0.7214	score on a scale
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	Daily 1 mg Dose	0.125	Standard Deviation 0.6938	score on a scale
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	Daily 3 mg Dose	-0.213	Standard Deviation 0.6145	score on a scale
Change From Baseline in Enhanced Liver Fibrosis Score at Week 48	Placebo	0.263	Standard Deviation 0.5767	score on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Daily 0.3 mg Dose	7
Overall Study	STARTED	Daily 1 mg Dose	42
Overall Study	STARTED	Daily 3 mg Dose	55
Overall Study	STARTED	Placebo	56
Overall Study	COMPLETED	Daily 0.3 mg Dose	7
Overall Study	COMPLETED	Daily 1 mg Dose	37
Overall Study	COMPLETED	Daily 3 mg Dose	44
Overall Study	COMPLETED	Placebo	49
Overall Study	NOT COMPLETED	Daily 0.3 mg Dose	0
Overall Study	NOT COMPLETED	Daily 1 mg Dose	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events400

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	Events
other	Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Daily 0.3 mg Dose	1	7	1
other	Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Daily 1 mg Dose	0	42	0
other	Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Daily 3 mg Dose	1	55	1
other	Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo	0	56	0
other	Haematoma	Vascular disorders	Daily 0.3 mg Dose	1	7	1
other	Haematoma	Vascular disorders	Daily 1 mg Dose	0	42	0
other	Haematoma	Vascular disorders	Daily 3 mg Dose	1	55	1
other	Haematoma	Vascular disorders	Placebo	0	56	0
other	Hypertension	Vascular disorders	Daily 0.3 mg Dose	1	7	1
other	Hypertension	Vascular disorders	Daily 1 mg Dose	0	42	0

1 to 10 of 400Source ClinicalTrials.gov

See all 400 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Daily 0.3 mg Dose	0	7
Total, all-cause mortality	Daily 1 mg Dose	1	42
Total, all-cause mortality	Daily 3 mg Dose	0	55
Total, all-cause mortality	Placebo	0	56
Total, other adverse events	Daily 0.3 mg Dose	5	7
Total, other adverse events	Daily 1 mg Dose	40	42
Total, other adverse events	Daily 3 mg Dose	52	55
Total, other adverse events	Placebo	49	56
Total, serious adverse events	Daily 0.3 mg Dose	0	7
Total, serious adverse events	Daily 1 mg Dose	11	42

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
37732990	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.

GET https://conductscience.org/api/trials/v1/NCT04210245

GET https://conductscience.org/api/trials/v1/NCT04210245/events?page=2

API reference For AI assistants