NCT04874233

Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers

A 61-day Randomized, Double Blind, Placebo-controlled Trial to Assess the Safety and Efficacy of Three Doses of HU6 in Subjects With Elevated Liver Fat and High Body Mass Index (28 to 45 kg/m2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 28 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat.

Detailed description

This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects with high BMI and evidence of elevated liver fat. Subjects will be screened over a 45 day period to determine their eligibility based on specific history, physical, laboratory and imaging evaluations as per the Schedule of Assessments. Due to scheduling of the procedures, multiple visits will likely be necessary to complete the screening process. However, if all screening assessments and procedures, including the MRI, can be completed within 30 days of the first dose, then a single screening visit is permissible.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	HU6	HU6 is active study drug
DRUG	Placebo	Non-active study drug N = 20

Timeline

• Start date: 2021-04-19
• Primary completion: 2021-11-30
• Completion: 2021-12-15
• First posted: 2021-05-05
• Last updated: 2024-03-01
• Results posted: 2024-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study