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
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

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 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
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

Primary Outcome Measures

Name	Time	Method
Change in absolute liver fat content as measured by MRI from Baseline to Week 24	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in percentage liver fat content as measure by MRI from Baseline to Week 24	24 weeks

Trial Locations

Locations (22)

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

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

NGM Clinical Study Site 910; 🇺🇸 Dallas, Texas, United States

NGM Clinical Study Site 905; 🇺🇸 San Antonio, Texas, United States

NGM Clinical Study Site 909; 🇺🇸 San Antonio, Texas, United States

NGM Clinical Study Site 908; 🇺🇸 Seattle, Washington, United States

NGM Clinical Study Site 704; 🇦🇺 Adelaide, South Australia, Australia

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

NGM Clinical Study Site 911; 🇺🇸 Richmond, Virginia, United States

NGM Clinical Study Site 916; 🇵🇷 San Juan, Puerto Rico

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

NGM Clinical Study Site 703; 🇦🇺 Sydney, New South Wales, Australia

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

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

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

NGM Clinical Study Site 920; 🇺🇸 Rollingwood, Texas, United States

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

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

NGM Clinical Study Site 701; 🇦🇺 Melbourne, Victoria, Australia

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

NGM Clinical Study Site 904; 🇺🇸 Charlottesville, Virginia, United States

NGM Clinical Study Site 705; 🇦🇺 Melbourne, Victoria, Australia