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)
June 16, 2025 updated by: NGM Biopharmaceuticals, Inc
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico
- NGM Clinical Study Site
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Arizona
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Chandler, Arizona, United States, 85224
- NGM Clinical Study Site
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Tucson, Arizona, United States, 85712
- NGM Clinical Study Site 814
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Tucson, Arizona, United States, 85712
- NGM Clinical Study Site 816
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Arkansas
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North Little Rock, Arkansas, United States, 72117
- NGM Clinical Study Site
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California
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Fresno, California, United States, 93720
- NGM Clinical Study Site
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La Jolla, California, United States, 92093
- NGM Clinical Study Site
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Los Angeles, California, United States, 90036
- NGM Clinical Study Site
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Los Angeles, California, United States, 90057
- NGM Clinical Study Site
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Poway, California, United States, 92064
- NGM Clinical Study Site
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Rialto, California, United States, 92377
- NGM Clinical Study Site
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Florida
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Boca Raton, Florida, United States, 33434
- NGM Clinical Study Site
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Lakewood Ranch, Florida, United States, 34211
- NGM Clinical Study Site
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Port Orange, Florida, United States, 32127
- NGM Clinical Study Site
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Sarasota, Florida, United States, 34240
- NGM Clinical Study Site
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The Villages, Florida, United States, 32162
- NGM Clinical Study Site
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Illinois
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Chicago, Illinois, United States, 60611
- NGM Clinical Study Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- NGM Clinical Study Site
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Maryland
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Baltimore, Maryland, United States, 21202
- NGM Clinical Study Site
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Michigan
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Ann Arbor, Michigan, United States, 48109
- NGM Clinical Study Site
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Mississippi
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Flowood, Mississippi, United States, 39232
- NGM Clinical Study Site
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Jackson, Mississippi, United States, 39216
- NGM Clinical Study Site
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Missouri
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Kansas City, Missouri, United States, 64131
- NGM Clinical Study Site
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Saint Louis, Missouri, United States, 63104
- NGM Clinical Study Site
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New York
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New York, New York, United States, 10029
- NGM Clinical Study Site
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North Carolina
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Durham, North Carolina, United States, 27708
- NGM Clinical Study Site
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Fayetteville, North Carolina, United States, 28304
- NGM Clinical Study Site
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Tennessee
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Germantown, Tennessee, United States, 38138
- NGM Clinical Study Site
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Hermitage, Tennessee, United States, 37076
- NGM Clinical Study Site
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Texas
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Austin, Texas, United States, 78757
- NGM Clinical Study Site
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Edinburg, Texas, United States, 78539
- NGM Clinical Study Site
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Edinburg, Texas, United States, 78539
- NGM Clinical Study Site 845
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Houston, Texas, United States, 77030
- NGM Clinical Study Site
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San Antonio, Texas, United States, 78229
- NGM Clinical Study Site
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San Antonio, Texas, United States, 78233
- NGM Clinical Study Site
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Virginia
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Richmond, Virginia, United States, 23298
- NGM Clinical Study Site
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Richmond, Virginia, United States, 23226
- NGM Clinical Study Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically confirmed NASH diagnosis as defined by the NASH CRN
- Total liver fat content of ≥ 8% as measured by MRI-PDFF
Exclusion Criteria:
- Clinically significant acute or chronic liver disease of an etiology other than NASH
- Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
- History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
- Prior or pending liver transplantation
Other protocol-defined inclusion/exclusion criteria could apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Administered by subcutaneous injection
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Placebo for NGM282
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Experimental: NGM282 Dose 1
Administered by subcutaneous injection
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NGM282
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Experimental: NGM282 Dose 2
Administered by subcutaneous injection
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NGM282
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Experimental: NGM282 Dose 3
Administered by subcutaneous injection
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NGM282
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Time Frame: Baseline up to Week 24
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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.
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Baseline up to Week 24
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Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Time Frame: Baseline up to Week 24
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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.
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Baseline up to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Time Frame: Baseline, Week 12, Week 24, and Week 30
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Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).
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Baseline, Week 12, Week 24, and Week 30
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Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Time Frame: Baseline to Week 12, Week 24, and Week 30
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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.
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Baseline to Week 12, Week 24, and Week 30
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Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Time Frame: Baseline to Week 12, Week 24 and Week 30
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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%).
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Baseline to Week 12, Week 24 and Week 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: NGM Study Director, NGM Biopharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2019
Primary Completion (Actual)
March 4, 2021
Study Completion (Actual)
March 29, 2021
Study Registration Dates
First Submitted
April 9, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (Actual)
April 11, 2019
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
June 16, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.