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NCT04709913
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
Phase 1 trial testing HU6 in NASH - Nonalcoholic Steatohepatitis in 30 participants. Completed in 30 July 2021.
30 April 2021
Quick facts
| Lead sponsor | Rivus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 4 January 2021 |
| Primary completion | 30 April 2021 |
| Estimated completion | 30 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- HU6 — full drug profile →
Conditions studied
- NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
Sponsor
Rivus Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 45, any sex, with NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04709913
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HU6
Trials testing the same drug.
- 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
- NCT04874233 — Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers · Phase 2 · 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
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04709913 (US National Library of Medicine, public domain)
- 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: 16 August 2021
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/NCT04709913.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing