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Phase 2Recruiting

A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH) (AMPLIFY)

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)

Sponsor
Rivus Pharmaceuticals, Inc. (Industry)
Enrollment
180 planned
Conditions
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Interventions
HU6; Placebo
Ages
adults, older adults
Registry
NCT07491458

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

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

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Registered

  5. Started