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NCT05284617: HFpEF
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
Phase 2 trial testing HU6 in Heart Failure With Preserved Ejection Fraction in 67 participants. Completed in 30 May 2024.
24 May 2024
Quick facts
| Lead sponsor | Rivus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 30 October 2022 |
| Primary completion | 24 May 2024 |
| Estimated completion | 30 May 2024 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- HU6 — full drug profile →
- Placebo
Conditions studied
- Heart Failure With Preserved Ejection Fraction — all drugs for Heart Failure With Preserved Ejection Fraction →
Sponsor
Rivus Pharmaceuticals, Inc. — full company profile →
Who can join
40 and older, any sex, with Heart Failure With Preserved Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within \~14 days of the last dose.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
2023 Consensus of Taiwan Society of Cardiology on the Pharmacological Treatment of Chronic Heart Failure.
Chiang CE, Hung CL, Wu YW, Lin TH, et al · · 2023 · cited 17× · PMID 37229331 · DOI 10.6515/acs.202305_39(3).20230301a -
Precision Medicine: Therapeutically Targeting Mitochondrial Alterations in Heart Failure.
Parker AM, Lees JG, Murray AJ, Velagic A, et al · · 2025 · cited 5× · PMID 40845481 · DOI 10.1016/j.jacbts.2025.101345 -
Novel Controlled Metabolic Accelerator for Obesity-Related HFpEF: The HuMAIN-HFpEF Randomized Clinical Trial.
Pandey A, Lewis GD, Borlaug BA, Shah SJ, et al · · 2025 · cited 4× · PMID 40072462 · DOI 10.1001/jamacardio.2025.0103 -
Obesity and Heart Failure: A New Era Begins.
Borlaug BA, Kindel TL. · · 2024 · cited 2× · PMID 38447633 · DOI 10.1016/j.cardfail.2024.02.009 -
Regulation of mitochondrial biogenesis and energy metabolism in the heart.
She P, Mo F, Zhu P, Zhong TP. · · 2026 · PMID 41680976 · DOI 10.1097/cm9.0000000000004011 -
The role of transmembrane proton transport rates in mild mitochondrial uncoupling by arylamide substituted fatty acids.
Pacchini E, McNaughton DA, Pye A, Wilson KA, et al · · 2026 · PMID 41451303 · DOI 10.1039/d5sc06530e
Verify or expand the search:
- PubMed search for NCT05284617
- 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
- NCT04874233 — Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers · 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 Heart Failure With Preserved Ejection Fraction
Currently open trials in the same condition.
- NCT06833138 — Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillati · NA · recruiting
- NCT06937827 — Transitions of Care Clinic (TOCC) · NA · recruiting
- NCT07037459 — Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity · Phase 3 · recruiting
- NCT06702501 — The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF) · NA · recruiting
- NCT06616974 — A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction · 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
- NCT05433506 — Safety and Pharmacokinetics of HU6 · Phase 1 · 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 NCT05284617 (US National Library of Medicine, public domain)
- 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: 26 August 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/NCT05284617.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing