Phase 2
Completed N=82
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov NCT02443116 ↗
Enrolled (actual)
82
Serious AEs
4.7%
Results posted
Jun 2025
Primary outcomePrimary: Change in Absolute Liver Fat Content (Part 1) — -9.68; -11.91; -0.85 percent of liver fat — p=<0.001
Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Absolute Liver Fat Content (Part 1) |
-9.68; -11.91; -0.85 | <0.001 sig |
| PRIMARY Change in Absolute Liver Fat Content (Part 2) |
-4.15; -8.21; -10.38; -8.36; -4.51; -3.87 | — |
| PRIMARY Change in Absolute Liver Fat Content (Part 3) |
-6.54; -0.93; -8.43; -1.89; -3.04; -2.05 | — |
| SECONDARY Percentage Change in Liver Fat Content (Part 1) |
-47.98; -60.09; -2.57 | — |
| SECONDARY Change in Absolute Liver Fat Content (Part 2) |
-4.15; -8.21; -10.38; -8.36; -4.51; -3.87 | — |
| SECONDARY Percentage Change in Liver Fat Content (Part 2) |
-24.95; -42.90; -58.72; -45.92; -29.09; -55.10 | — |
| SECONDARY Change in Absolute Liver Fat Content (Part 3) |
-6.54; -0.93; -8.43; -1.89; -3.04; -2.05 | — |
| SECONDARY Percentage Change in Liver Fat Content (Part 3) |
-36.59; -2.17; -45.27; -6.88; -38.76; -13.10 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females, between 18 and 75 years of age, inclusive
- Histologically confirmed NASH diagnosis
Exclusion Criteria
- Clinically significant acute or chronic liver disease
- Prior liver transplantation
Data sourced from ClinicalTrials.gov (NCT02443116). 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. Informational only — not medical advice.