A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Start Date
2/13/2026
Completion Date
2/1/2028
Summary
Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.
Detailed Description
This is a 2-part randomized, double-blind, placebo-controlled, multicenter trial with an open label extension (OLE) to evaluate the safety and exposure of HU6 as well as the effect of HU6 on liver fat and other symptoms associated with MASH. The 2-part trial design consists of a blinded intervention period and, for participants who completed the blinded intervention period, an option to continue in an OLE intervention period. The blinded trial design consists of a screening period, a blinded intervention period, an end of treatment (EOT)/early termination (ET) visit, a safety follow-up visit, and two long-term follow up visits.
Eligibility Criteria
Age Range: 30 years to No maximum
Interventions
HU6
Placebo
Conditions
Locations
Arizona Liver Health - Chandler
Chandler, Arizona 85224
United States
Arizona Liver Health - Peoria
Peoria, Arizona 85381
United States
Arizona Liver Health - Tucson
Tucson, Arizona 85712
United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas 72205
United States
National Institute of Clinical Research
Garden Grove, California 92844
United States
Catalina Research Institute
Montclair, California 91763
United States
Knowledge Research Center
Orange, California 92868
United States
Charter Research LLC - Orlando
Orlando, Florida 32803
United States
Charter Research LLC - Chicago
Chicago, Illinois 60618
United States
Delta Research Partners of Bastrop, LLC
Bastrop, Louisiana 71220
United States
Delta Research Partners of West Monroe, LLC
West Monroe, Louisiana 71291
United States
Clinical Research Institute of Michigan
Clinton Township, Michigan 48038
United States
Nucleus Network Minneapolis
Saint Paul, Minnesota 55114
United States
Kansas City Research Institute
Kansas City, Missouri 64131
United States
KAD Clinical Research
St Louis, Missouri 63123
United States
Jubilee Clinical Research, LLC.
Las Vegas, Nevada 89106
United States
Coastal Research Institute
Fayetteville, North Carolina 28304
United States
Clinical Research Institute of Ohio, LLC (CRIOH)
Westlake, Ohio 44145
United States
Tekton Research - Yukon
Yukon, Oklahoma 73099
United States
Innovative Clinical Research, LLC
Clarksville, Tennessee 37040
United States
IMA Clinical Research (Austin)
Austin, Texas 78745
United States
Pinnacle Clinical Research - Austin
Austin, Texas 78757
United States
Bellaire Clinical Research, LLC
Bellaire, Texas 77401
United States
Pinnacle Clinical Research - Corpus Christi
Corpus Christi, Texas 78404
United States
Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626
United States
HRI - Medical Center, LLC
Houston, Texas 77030
United States
Houston Research Institute
Houston, Texas 77079
United States
HRI - Pasadena, LLC
Pasadena, Texas 77505
United States
Quality Research
San Antonio, Texas 78209
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229
United States
HRI - Sugarland, LLC
Sugar Land, Texas 77478
United States