Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

Phase 2

Completed

• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Interventions: Biological: NGM282; Other: Placebo

• Registration Number: NCT02443116
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-13
• Study Start: 2015-07-31
• Primary Completion: 2019-12-06
• Study Completion: 2020-01-17
• Results First Submitted: 2025-03-11
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-07
• Last Update Submitted: 2025-06-07
• Results First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 - NGM282 3mg	NGM282	Cohort 2 - NGM282 3mg
Cohort 4 - Placebo	Placebo	Cohort 4 - Placebo
Cohort 1 - Placebo	Placebo	Cohort 1 - Placebo
Cohort 1 - NGM282 6mg	NGM282	Cohort 1 - NGM282 6mg
Cohort 2 - NGM282 1mg	NGM282	Cohort 2 - NGM282 1mg
Cohort 3 - NGM282 1mg	NGM282	Cohort 3 - NGM282 1mg
Cohort 1 - NGM282 3mg	NGM282	Cohort 1 - NGM282 3mg
Cohort 2 - NGM282 0.3mg	NGM282	Cohort 2 - NGM282 0.3mg
Cohort 4 - NGM282 1mg	NGM282	Cohort 4 - NGM282 1mg

Primary Outcome Measures

Name	Time	Method
Change in Absolute Liver Fat Content (Part 3)	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)	Up to Week 12	Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Change in Absolute Liver Fat Content (Part 2)	Up to Week 12	Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Secondary Outcome Measures

Name	Time	Method
Percentage Change in Liver Fat Content (Part 1)	Up to Week 12	Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).
Change in Absolute Liver Fat Content (Part 2)	Up to Week 18	Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Percentage Change in Liver Fat Content (Part 2)	Up to Week 18	Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Change in Absolute Liver Fat Content (Part 3)	Up to Week 30	Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Percentage Change in Liver Fat Content (Part 3)	Up to Week 30	Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Trial Locations

Locations (22)

NGM Clinical Study Site 922; 🇺🇸 Chandler, Arizona, United States

NGM Clinical Study Site 923; 🇺🇸 Tucson, Arizona, United States

NGM Clinical Study Site 924; 🇺🇸 Los Angeles, California, United States

NGM Clinical Study Site 901; 🇺🇸 San Diego, California, United States

NGM Clinical Study Site 902; 🇺🇸 Denver, Colorado, United States

NGM Clinical Study Site 917; 🇺🇸 Lakewood Ranch, Florida, United States

NGM Clinical Study Site 906; 🇺🇸 Chicago, Illinois, United States

NGM Clinical Study Site 918; 🇺🇸 Kansas City, Missouri, United States

NGM Clinical Study Site 903; 🇺🇸 Durham, North Carolina, United States

NGM Clinical Study Site 921; 🇺🇸 Germantown, Tennessee, United States

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