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 ID: NCT03912532
Last Updated: 2025-07-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
171 participants
INTERVENTIONAL
2019-05-16
2021-03-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02443116
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
NCT02316717
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
NCT06318169
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
NCT05842512
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT01694849
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NGM282 Dose 1
Administered by subcutaneous injection
NGM282
NGM282
NGM282 Dose 2
Administered by subcutaneous injection
NGM282
NGM282
NGM282 Dose 3
Administered by subcutaneous injection
NGM282
NGM282
Placebo
Administered by subcutaneous injection
Placebo
Placebo for NGM282
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NGM282
NGM282
Placebo
Placebo for NGM282
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Total liver fat content of ≥ 8% as measured by MRI-PDFF
Exclusion Criteria
2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis
3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters
4. Prior or pending liver transplantation
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
NGM Study Director
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NGM Clinical Study Site
Chandler, Arizona, United States
NGM Clinical Study Site 814
Tucson, Arizona, United States
NGM Clinical Study Site 816
Tucson, Arizona, United States
NGM Clinical Study Site
North Little Rock, Arkansas, United States
NGM Clinical Study Site
Fresno, California, United States
NGM Clinical Study Site
La Jolla, California, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Los Angeles, California, United States
NGM Clinical Study Site
Poway, California, United States
NGM Clinical Study Site
Rialto, California, United States
NGM Clinical Study Site
Boca Raton, Florida, United States
NGM Clinical Study Site
Lakewood Rch, Florida, United States
NGM Clinical Study Site
Port Orange, Florida, United States
NGM Clinical Study Site
Sarasota, Florida, United States
NGM Clinical Study Site
The Villages, Florida, United States
NGM Clinical Study Site
Chicago, Illinois, United States
NGM Clinical Study Site
Baton Rouge, Louisiana, United States
NGM Clinical Study Site
Baltimore, Maryland, United States
NGM Clinical Study Site
Ann Arbor, Michigan, United States
NGM Clinical Study Site
Flowood, Mississippi, United States
NGM Clinical Study Site
Jackson, Mississippi, United States
NGM Clinical Study Site
Kansas City, Missouri, United States
NGM Clinical Study Site
St Louis, Missouri, United States
NGM Clinical Study Site
New York, New York, United States
NGM Clinical Study Site
Durham, North Carolina, United States
NGM Clinical Study Site
Fayetteville, North Carolina, United States
NGM Clinical Study Site
Germantown, Tennessee, United States
NGM Clinical Study Site
Hermitage, Tennessee, United States
NGM Clinical Study Site
Austin, Texas, United States
NGM Clinical Study Site 845
Edinburg, Texas, United States
NGM Clinical Study Site
Edinburg, Texas, United States
NGM Clinical Study Site
Houston, Texas, United States
NGM Clinical Study Site
San Antonio, Texas, United States
NGM Clinical Study Site
San Antonio, Texas, United States
NGM Clinical Study Site
Richmond, Virginia, United States
NGM Clinical Study Site
Richmond, Virginia, United States
NGM Clinical Study Site
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Harrison SA, Abdelmalek MF, Neff G, Gunn N, Guy CD, Alkhouri N, Bashir MR, Freilich B, Kohli A, Khazanchi A, Sheikh MY, Leibowitz M, Rinella ME, Siddiqui MS, Kipnes M, Moussa SE, Younes ZH, Bansal M, Baum SJ, Borg B, Ruane PJ, Thuluvath PJ, Gottwald M, Khan M, Chen C, Melchor-Khan L, Chang W, DePaoli AM, Ling L, Lieu HD. Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2022 Jul;7(7):603-616. doi: 10.1016/S2468-1253(22)00017-6. Epub 2022 Mar 21.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-0108
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.