NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Three Doses of NGM282 Administered for 24 Weeks for the Treatment of Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
| NCT number | NCT03912532 |
| Other study ID # | 18-0108 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | May 16, 2019 |
| Est. completion date | March 29, 2021 |
| Verified date | January 2022 |
| Source | NGM Biopharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
| Status | Completed |
| Enrollment | 171 |
| Est. completion date | March 29, 2021 |
| Est. primary completion date | March 4, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: 1. Histologically confirmed NASH diagnosis as defined by the NASH CRN 2. Total liver fat content of = 8% as measured by MRI-PDFF Exclusion Criteria: 1. Clinically significant acute or chronic liver disease of an etiology other than NASH 2. Evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis 3. History or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters 4. Prior or pending liver transplantation Other protocol-defined inclusion/exclusion criteria could apply. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | NGM Clinical Study Site | San Juan | |
| United States | NGM Clinical Study Site | Ann Arbor | Michigan |
| United States | NGM Clinical Study Site | Austin | Texas |
| United States | NGM Clinical Study Site | Baltimore | Maryland |
| United States | NGM Clinical Study Site | Baton Rouge | Louisiana |
| United States | NGM Clinical Study Site | Boca Raton | Florida |
| United States | NGM Clinical Study Site | Chandler | Arizona |
| United States | NGM Clinical Study Site | Chicago | Illinois |
| United States | NGM Clinical Study Site | Durham | North Carolina |
| United States | NGM Clinical Study Site | Edinburg | Texas |
| United States | NGM Clinical Study Site | Fayetteville | North Carolina |
| United States | NGM Clinical Study Site | Flowood | Mississippi |
| United States | NGM Clinical Study Site | Fresno | California |
| United States | NGM Clinical Study Site | Germantown | Tennessee |
| United States | NGM Clinical Study Site | Hermitage | Tennessee |
| United States | NGM Clinical Study Site | Houston | Texas |
| United States | NGM Clinical Study Site | Jackson | Mississippi |
| United States | NGM Clinical Study Site | Kansas City | Missouri |
| United States | NGM Clinical Study Site | La Jolla | California |
| United States | NGM Clinical Study Site | Lakewood Ranch | Florida |
| United States | NGM Clinical Study Site | Los Angeles | California |
| United States | NGM Clinical Study Site | Los Angeles | California |
| United States | NGM Clinical Study Site | New York | New York |
| United States | NGM Clinical Study Site | North Little Rock | Arkansas |
| United States | NGM Clinical Study Site | Port Orange | Florida |
| United States | NGM Clinical Study Site | Poway | California |
| United States | NGM Clinical Study Site | Rialto | California |
| United States | NGM Clinical Study Site | Richmond | Virginia |
| United States | NGM Clinical Study Site | Richmond | Virginia |
| United States | NGM Clinical Study Site | Saint Louis | Missouri |
| United States | NGM Clinical Study Site | San Antonio | Texas |
| United States | NGM Clinical Study Site | San Antonio | Texas |
| United States | NGM Clinical Study Site | Sarasota | Florida |
| United States | NGM Clinical Study Site | The Villages | Florida |
| United States | NGM Clinical Study Site | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| NGM Biopharmaceuticals, Inc |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants achieving a histologic treatment effect (histologic response) as determined by the NASH CRN criteria after 24 weeks of NGM282 or matched placebo. | 24 weeks | ||
| Primary | Evaluate safety and tolerability of NGM282 in participants with NASH as a function of dose level after up to 24 weeks of treatment with NGM282. | 24 weeks |
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