Phase 2
N=171
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)
NASH - Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03912532 ↗Enrolled (actual)
171
Serious AEs
5.3%
Results posted
Jul 2025
Primary outcome: Primary: Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis — 0.24; 0.25; 0.27; 0.23 score on a scale — p=0.5534
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NGM282 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NGM Biopharmaceuticals, Inc
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis |
0.24; 0.25; 0.27; 0.23 | 0.5534 |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis |
30; 34; 38; 36; 11; 12 | — |
| SECONDARY Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis |
19.13; 17.40; 18.69; 17.00; 14.43; 10.62 | — |
| SECONDARY Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis |
-4.28; -7.50; -11.37; -1.49; -3.73; -7.35 | — |
| SECONDARY Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis |
3; 4; 17; 0; 35; 33 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03912532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.