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)
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)
1 other identifier
interventional
171
2 countries
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedStudy Start
First participant enrolled
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2021
CompletedResults Posted
Study results publicly available
July 3, 2025
CompletedJuly 3, 2025
March 1, 2025
1.8 years
April 9, 2019
March 7, 2025
June 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
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.
Baseline up to Week 24
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
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.
Baseline up to Week 24
Secondary Outcomes (3)
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Baseline, Week 12, Week 24, and Week 30
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
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
Study Arms (4)
NGM282 Dose 1
EXPERIMENTALAdministered by subcutaneous injection
NGM282 Dose 2
EXPERIMENTALAdministered by subcutaneous injection
NGM282 Dose 3
EXPERIMENTALAdministered by subcutaneous injection
Placebo
PLACEBO COMPARATORAdministered by subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed NASH diagnosis as defined by the NASH CRN
- Total liver fat content of ≥ 8% as measured by MRI-PDFF
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
NGM Clinical Study Site
Chandler, Arizona, 85224, United States
NGM Clinical Study Site 814
Tucson, Arizona, 85712, United States
NGM Clinical Study Site 816
Tucson, Arizona, 85712, United States
NGM Clinical Study Site
North Little Rock, Arkansas, 72117, United States
NGM Clinical Study Site
Fresno, California, 93720, United States
NGM Clinical Study Site
La Jolla, California, 92093, United States
NGM Clinical Study Site
Los Angeles, California, 90036, United States
NGM Clinical Study Site
Los Angeles, California, 90057, United States
NGM Clinical Study Site
Poway, California, 92064, United States
NGM Clinical Study Site
Rialto, California, 92377, United States
NGM Clinical Study Site
Boca Raton, Florida, 33434, United States
NGM Clinical Study Site
Lakewood Rch, Florida, 34211, United States
NGM Clinical Study Site
Port Orange, Florida, 32127, United States
NGM Clinical Study Site
Sarasota, Florida, 34240, United States
NGM Clinical Study Site
The Villages, Florida, 32162, United States
NGM Clinical Study Site
Chicago, Illinois, 60611, United States
NGM Clinical Study Site
Baton Rouge, Louisiana, 70809, United States
NGM Clinical Study Site
Baltimore, Maryland, 21202, United States
NGM Clinical Study Site
Ann Arbor, Michigan, 48109, United States
NGM Clinical Study Site
Flowood, Mississippi, 39232, United States
NGM Clinical Study Site
Jackson, Mississippi, 39216, United States
NGM Clinical Study Site
Kansas City, Missouri, 64131, United States
NGM Clinical Study Site
St Louis, Missouri, 63104, United States
NGM Clinical Study Site
New York, New York, 10029, United States
NGM Clinical Study Site
Durham, North Carolina, 27708, United States
NGM Clinical Study Site
Fayetteville, North Carolina, 28304, United States
NGM Clinical Study Site
Germantown, Tennessee, 38138, United States
NGM Clinical Study Site
Hermitage, Tennessee, 37076, United States
NGM Clinical Study Site
Austin, Texas, 78757, United States
NGM Clinical Study Site 845
Edinburg, Texas, 78539, United States
NGM Clinical Study Site
Edinburg, Texas, 78539, United States
NGM Clinical Study Site
Houston, Texas, 77030, United States
NGM Clinical Study Site
San Antonio, Texas, 78229, United States
NGM Clinical Study Site
San Antonio, Texas, 78233, United States
NGM Clinical Study Site
Richmond, Virginia, 23226, United States
NGM Clinical Study Site
Richmond, Virginia, 23298, United States
NGM Clinical Study Site
San Juan, Puerto Rico
Related Publications (1)
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.
PMID: 35325622DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Clinical Operations
- Organization
- NGM Biopharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
NGM Study Director
NGM Biopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 11, 2019
Study Start
May 16, 2019
Primary Completion
March 4, 2021
Study Completion
March 29, 2021
Last Updated
July 3, 2025
Results First Posted
July 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share