A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Sponsor
- NGM Biopharmaceuticals, Inc
- Enrollment
- 254
- Locations
- 22
- Primary Endpoint
- Change in Absolute Liver Fat Content (Part 3)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
Investigators
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
Arms & Interventions
Cohort 1 - Placebo
Cohort 1 - Placebo
Intervention: Placebo
Cohort 1 - NGM282 3mg
Cohort 1 - NGM282 3mg
Intervention: NGM282
Cohort 1 - NGM282 6mg
Cohort 1 - NGM282 6mg
Intervention: NGM282
Cohort 2 - NGM282 0.3mg
Cohort 2 - NGM282 0.3mg
Intervention: NGM282
Cohort 2 - NGM282 1mg
Cohort 2 - NGM282 1mg
Intervention: NGM282
Cohort 2 - NGM282 3mg
Cohort 2 - NGM282 3mg
Intervention: NGM282
Cohort 3 - NGM282 1mg
Cohort 3 - NGM282 1mg
Intervention: NGM282
Cohort 4 - Placebo
Cohort 4 - Placebo
Intervention: Placebo
Cohort 4 - NGM282 1mg
Cohort 4 - NGM282 1mg
Intervention: NGM282
Outcomes
Primary Outcomes
Change in Absolute Liver Fat Content (Part 3)
Time Frame: Up to Week 24
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Change in Absolute Liver Fat Content (Part 1)
Time Frame: Up to Week 12
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Change in Absolute Liver Fat Content (Part 2)
Time Frame: Up to Week 12
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Secondary Outcomes
- Percentage Change in Liver Fat Content (Part 1)(Up to Week 12)
- Change in Absolute Liver Fat Content (Part 2)(Up to Week 18)
- Percentage Change in Liver Fat Content (Part 2)(Up to Week 18)
- Change in Absolute Liver Fat Content (Part 3)(Up to Week 30)
- Percentage Change in Liver Fat Content (Part 3)(Up to Week 30)