Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

Summary

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.

Timeline

Start

2022-10-30

Primary completion

2024-05-24

Completion

2024-05-30

Outcome

Met primary endpoint

paper HU6 (vs placebo) significantly decreased weight (between-group difference, -2.86 kg; 95% CI, -4.68 to -1.04 kg; P = .003) PMID 40072462 ↗

Publications

• Pandey A, Lewis GD, Borlaug BA, Shah SJ, Sauer AJ, Litwin S, Sharma K, Jorkasky DK, Tarka EA, Khan SM, Kitzman DW. Novel Controlled Metabolic Accelerator for Obesity-Related HFpEF: The HuMAIN-HFpEF Randomized Clinical Trial. JAMA Cardiol. 2025 Jun 1;10(6):609-616. doi: 10.1001/jamacardio.2025.0103.

Drugs

Indications