Nonalcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group Multiple-center Study With Additional Open-label Single-blind and Placebo-controlled 24-Week Histology Cohorts to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for Up to 24 Weeks in Patients With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
| Verified date | September 2020 |
| Source | NGM Biopharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
| Status | Completed |
| Enrollment | 254 |
| Est. completion date | January 17, 2020 |
| Est. primary completion date | December 6, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | NGM Clinical Study Site 704 | Adelaide | South Australia |
| Australia | NGM Clinical Study Site 701 | Melbourne | Victoria |
| Australia | NGM Clinical Study Site 705 | Melbourne | Victoria |
| Australia | NGM Clinical Study Site 703 | Sydney | New South Wales |
| Puerto Rico | NGM Clinical Study Site 916 | San Juan | |
| United States | NGM Clinical Study Site 922 | Chandler | Arizona |
| United States | NGM Clinical Study Site 904 | Charlottesville | Virginia |
| United States | NGM Clinical Study Site 906 | Chicago | Illinois |
| United States | NGM Clinical Study Site 910 | Dallas | Texas |
| United States | NGM Clinical Study Site 902 | Denver | Colorado |
| United States | NGM Clinical Study Site 903 | Durham | North Carolina |
| United States | NGM Clinical Study Site 921 | Germantown | Tennessee |
| United States | NGM Clinical Study Site 918 | Kansas City | Missouri |
| United States | NGM Clinical Study Site 917 | Lakewood Ranch | Florida |
| United States | NGM Clinical Study Site 924 | Los Angeles | California |
| United States | NGM Clinical Study Site 911 | Richmond | Virginia |
| United States | NGM Clinical Study Site 920 | Rollingwood | 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 901 | San Diego | California |
| United States | NGM Clinical Study Site 908 | Seattle | Washington |
| United States | NGM Clinical Study Site 923 | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd |
United States, Australia, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in absolute liver fat content as measured by MRI from Baseline to Week 24 | 24 weeks | ||
| Secondary | Change in percentage liver fat content as measure by MRI from Baseline to Week 24 | 24 weeks |
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