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

NCT04874233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-01

Study results available
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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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

HU6

HU6 is active study drug

DRUG

Placebo

Non-active study drug N = 20

Sponsors & Collaborators

  • Rivus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Amy Eastenson · Prism Clinic Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
28 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-11-30
Completion
2021-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04874233 on ClinicalTrials.gov