NASH - Nonalcoholic Steatohepatitis Clinical Trial
— HarmonyOfficial title:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
| Verified date | April 2023 |
| Source | Akero Therapeutics, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
| Status | Active, not recruiting |
| Enrollment | 128 |
| Est. completion date | May 2024 |
| Est. primary completion date | July 25, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Males and non-pregnant, non-lactating females between 18 - 75 years of age inclusive, based on the date of the screening visit. - Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes. - FibroScan® measurement > 8.5 kPa. - Biopsy-proven NASH. Must have had a liver biopsy obtained = 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of = 4 with at least a score of 1 in each of the following NAS components: - Steatosis (scored 0 to 3), - Ballooning degeneration (scored 0 to 2), and - Lobular inflammation (scored 0 to 3). Exclusion Criteria: - Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer. - Presence of cirrhosis on liver biopsy (stage 4 fibrosis). - Type 1 or uncontrolled Type 2 diabetes. Other inclusion and exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Akero Clinical Study Site | San Juan | |
| United States | Akero Clinical Study Site | Arlington | Texas |
| United States | Akero Clinical Study Site | Austin | Texas |
| United States | Akero Clinical Study Site | Baton Rouge | Louisiana |
| United States | Akero Clinical Study Site | Cedar Park | Texas |
| United States | Akero Clinical Study Site | Chandler | Arizona |
| United States | Akero Clinical Study Site | Charlotte | North Carolina |
| United States | Akero Clinical Study Site | Charlottesville | Virginia |
| United States | Akero Clinical Study Site | Chula Vista | California |
| United States | Akero Clinical Study Site | Cincinnati | Ohio |
| United States | Akero Clinical Study Site | Dallas | Texas |
| United States | Akero Clinical Study Site | Dallas | Texas |
| United States | Akero Clinical Study Site | Durham | North Carolina |
| United States | Akero Clinical Study Site | Edinburg | Texas |
| United States | Akero Clinical Study Site | Flowood | Mississippi |
| United States | Akero Clinical Study Site | Fort Myers | Florida |
| United States | Akero Clinical Study Site | Fort Worth | Texas |
| United States | Akero Clinical Study Site | Fresno | California |
| United States | Akero Clinical Study Site | Garland | Texas |
| United States | Akero Clinical Study Site | Glendale | Arizona |
| United States | Akero Clinical Study Site | Greenville | South Carolina |
| United States | Akero Clinical Study Site | Hermitage | Tennessee |
| United States | Akero Clinical Study Site | Houston | Texas |
| United States | Akero Clinical Study Site | Inverness | Florida |
| United States | Akero Clinical Study Site | Jackson | Mississippi |
| United States | Akero Clinical Study Site | La Jolla | California |
| United States | Akero Clinical Study Site | Lakewood Ranch | Florida |
| United States | Akero Clinical Study Site | Las Vegas | Nevada |
| United States | Akero Clinical Study Site | Los Angeles | California |
| United States | Akero Clinical Study Site | Los Angeles | California |
| United States | Akero Clinical Study Site | Los Angeles | California |
| United States | Akero Clinical Study Site | Marietta | Georgia |
| United States | Akero Clinical Study Site | Marrero | Louisiana |
| United States | Akero Clinical Study Site | Miami | Florida |
| United States | Akero Clinical Study Site | Miami | Florida |
| United States | Akero Clinical Study Site | Miami Lakes | Florida |
| United States | Akero Clinical Study Site | Morehead City | North Carolina |
| United States | Akero Clinical Study Site | Nashville | Tennessee |
| United States | Akero Clinical Study Site | North Little Rock | Arkansas |
| United States | Akero Clinical Study Site | Ocala | Florida |
| United States | Akero Clinical Study Site | Orange | California |
| United States | Akero Clinical Study Site | Panorama City | California |
| United States | Akero Clinical Study Site | Rialto | California |
| United States | Akero Clinical Study Site | Richmond | Virginia |
| United States | Akero Clinical Study Site | Richmond | Virginia |
| United States | Akero Clinical Study Site | San Antonio | Texas |
| United States | Akero Clinical Study Site | San Antonio | Texas |
| United States | Akero Clinical Study Site | San Antonio | Texas |
| United States | Akero Clinical Study Site | San Marcos | Texas |
| United States | Akero Clinical Study Site | Santa Ana | California |
| United States | Akero Clinical Study Site | Sarasota | Florida |
| United States | Akero Clinical Study Site | Topeka | Kansas |
| United States | Akero Clinical Study Site | Tucson | Arizona |
| United States | Akero Clinical Study Site | Webster | Texas |
| United States | Akero Clinical Study Site | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Akero Therapeutics, Inc |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system | 24 Weeks | ||
| Secondary | Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system | 24 Weeks, 96 Weeks | ||
| Secondary | Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system | 96 Weeks | ||
| Secondary | Responder based on NASH CRN: patients who had a decrease of = one point in fibrosis score | 24 Weeks, 96 Weeks | ||
| Secondary | Change from baseline in hepatic fat fraction | 24 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of markers of glycemic control - HbA1c | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of markers of glycemic control - C-Peptide | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of markers of glycemic control - Adiponectin | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of markers of glycemic control - HOMA-IR | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of non-invasive fibrosis biomarkers - ELF | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of non-invasive fibrosis biomarkers - Pro-C3 | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of non-invasive fibrosis biomarkers - NIS-4 | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®) | 24 Weeks, 48 Weeks, 96 Weeks | ||
| Secondary | Change from baseline of body weight | 24 Weeks, 48 Weeks, 96 Weeks |
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