A Parallel Treatment Group, Phase 2a, Double-blind, 4-arm Trial to Evaluate the Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Male and Female Participants Aged 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH) (AMPLIFY)

NCT07491458 Phase 2 RECRUITING

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.

Details

Lead sponsor	Rivus Pharmaceuticals, Inc.
Phase	Phase 2
Status	RECRUITING
Enrolment	180
Start date	2026-02-13
Completion	2028-02

Conditions

• MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions

• HU6
• Placebo

Primary outcomes

• Number and Percentage of Adverse Events (AEs) — 26 weeks
• Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF — 26 weeks
• Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF — 26 weeks
• Area Under the Plasma Concentration-Time Curve (AUC) — 26 weeks
• Trough Plasma Concentration (Ctrough) — 26 weeks
• Maximum Observed Plasma Concentration (Cmax) — 26 weeks

Countries

United States