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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
HU6 is being evaluated for efficacy in MASH
Placebo comparator
Arizona Liver Health - Chandler
Chandler, Arizona, United States
RECRUITINGArizona Liver Health - Peoria
Peoria, Arizona, United States
RECRUITINGArizona Liver Health - Tucson
Tucson, Arizona, United States
RECRUITINGBaptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Number and Percentage of Adverse Events (AEs)
Time frame: 26 weeks
Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF
Time frame: 26 weeks
Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF
Time frame: 26 weeks
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: 26 weeks
Trough Plasma Concentration (Ctrough)
Time frame: 26 weeks
Maximum Observed Plasma Concentration (Cmax)
Time frame: 26 weeks
Time to Maximum Plasma Concentration (Tmax)
Time frame: 26 weeks
Plasma Clearance of drug after extravascular administration (CL/F)
Time frame: 26 weeks
Volume of distribution after extravascular administration (V/F)
Time frame: 26 weeks
Drug elimination half-life (t½)
Time frame: 26 weeks
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National Institute of Clinical Research
Garden Grove, California, United States
RECRUITINGCatalina Research Institute
Montclair, California, United States
RECRUITINGKnowledge Research Center
Orange, California, United States
RECRUITINGCharter Research LLC - Orlando
Orlando, Florida, United States
RECRUITINGCharter Research LLC - Chicago
Chicago, Illinois, United States
RECRUITINGDelta Research Partners of Bastrop, LLC
Bastrop, Louisiana, United States
RECRUITING...and 21 more locations