Adults 28 to 65, any sex, with NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Change From Baseline in Liver Fat Content as Assessed by MRI-PDFFPrimary· Baseline and 61 days;
Percentage of Change from Baseline in Liver Fat Content as Assessed by MRI-PDFF at Day 61
Group
Value
95% CI
Active Treatment: HU6 150 mg
-26.8
± 17.4
Active Treatment: HU6 300 mg;
-35.6
± 13.8
Active Treatment: HU6 450 mg;
-33.0
± 18.4
Placebo Comparator Non-active Study Drug
5.4
± 19.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 61 days of dosing.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07170189 — Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6
· Phase 1
· completed
NCT05284617 — Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for S
· Phase 2
· completed
NCT04709913 — Multiple Ascending Dose Study of HU6 in High BMI Volunteers
· Phase 1
· completed
NCT04463017 — Ascending Dose Study of HU6 in Healthy Volunteers
· Phase 1
· completed
Other recruiting trials for NASH - Nonalcoholic Steatohepatitis
Currently open trials in the same condition.
NCT05499949 — The Franciscus Obesity NASH Study
· active not recruiting
NCT05023044 — Nonalcoholic Fatty Liver Disease in HIV Database
· active not recruiting
NCT04232566 — Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
· recruiting
NCT05165446 — Novel MRE Technique to Assess a Risk Factor for Liver Cancer
· active not recruiting
NCT04697810 — Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
· Phase 2
· recruiting
Other Rivus Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT07170189 — Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6
· Phase 1
· completed
NCT06486558 — Relative Bioavailability Study of HU6
· Phase 1
· completed
NCT06325930 — A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6
· Phase 1
· completed
NCT05284617 — Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for S
· Phase 2
· completed
NCT05433506 — Safety and Pharmacokinetics of HU6
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rivus Pharmaceuticals, Inc.
Last refreshed: 1 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04874233.