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NCT05433506
Safety and Pharmacokinetics of HU6
Phase 1 trial testing HU6 Tablet in Obese in 30 participants. Completed in 15 March 2023.
30 January 2023
Quick facts
| Lead sponsor | Rivus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 15 September 2022 |
| Primary completion | 30 January 2023 |
| Estimated completion | 15 March 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- HU6 Tablet
- HU6 Capsule
Conditions studied
- Obese — all drugs for Obese →
Sponsor
Rivus Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Obese. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Twelve subjects will be randomized (1:1) to treatment sequence to determine the order in which they will receive the tablet or capsule formulation in Period 1 and Period 2. Part 2 is an open-label study of up to 4 single, ascending dose levels of HU6 administered as the tablet formulation. Eight subjects will be enrolled to participate in all of the ascending study periods.
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 NCT05433506
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Obese
Currently open trials in the same condition.
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- NCT06562660 — The Effect of Mask Combined With High Flow Oxygen on Preoxygenation During Induction of General Anesthesia in Obese Pati · NA · recruiting
- NCT05819853 — Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome · Phase 3 · 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
- NCT04874233 — Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers · Phase 2 · 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 NCT05433506 (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: 20 March 2023
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/NCT05433506.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing