At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 enrolled
Drug / intervention
HU6 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating HU6 and Placebo for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
Enrollment StartApr 2021
First PostedMay 2021
Primary CompletionNov 2021
Study CompletionDec 2021
TodayJul 2026
First PostedMay 5, 2021
Enrollment StartApr 19, 2021
Primary CompletionNov 30, 2021
Study CompletionDec 15, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.2 years ago
Interventions
HU6drug
HU6 is active study drug
Placebodrug
Non-active study drug N = 20