Top-line data show significant weight loss with HU6 in patients with obesity-related HFpEF
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Key takeaways:
- HU6, a controlled metabolic accelerator, conferred significant weight loss in patients with obesity-related HFpEF.
- The full results of the phase 2a HuMAIN trial will be presented at a meeting in September.
HU6, a controlled metabolic accelerator, met the primary endpoint of weight reduction in patients with obesity-related heart failure with preserved ejection fraction, according to top-line results of the phase 2a HuMAIN trial.
HU6 (Rivus Pharmaceuticals) is an oral, once-daily, potentially first-in-class investigational treatment designed to promote weight loss while preserving muscle mass, according to a company press release.
HuMAIN was a double-blind, placebo-controlled, parallel-group, dose-escalation phase 2a trial conducted to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of daily HU6 150 mg, 300 mg and 450 mg in 66 patients aged 30 years or older with BMI more than 30 kg/m2 and obesity-related HFpEF.
The primary efficacy endpoint was weight reduction over 134 days of daily dosing. Secondary endpoints included change in exercise capacity, quality of life, body composition, cardiac function/structure and markers of cardiometabolic dysfunction.
The HuMAIN study met its primary endpoint and several secondary efficacy and pharmacodynamic endpoints, and treatment was well-tolerated, with a favorable safety profile, according to the release.
The full results of the phase 2a HuMAIN trial will be presented in a late-breaking clinical trial plenary session at the Heart Failure Society of America Annual Scientific Meeting, to be held Sept. 27-30 in Atlanta, the company stated in the release.
The company also stated in the release that enrollment has been completed in the phase 2 M-ACCEL trial of HU6 in patients with metabolic dysfunction-associated steatohepatitis, for which topline results are expected to be released in the first half of 2025; and that it “remains on track to engage health authorities for a phase 3 study in obesity-related HFpEF in 2025.”
"Inflammation caused by visceral fat is an important driver of obesity-related HFpEF, and reductions in body fat have been shown to lead to improved outcomes in patients. The goal is to reduce body fat while preserving lean muscle mass, especially in this often fragile and elderly patient population," Jayson Dallas, MD, CEO of Rivus Pharmaceuticals, said in the release. "We believe that the HuMAIN data strongly supports the potential of HU6 to be the first disease-modifying treatment for HFpEF by enabling fat-specific weight loss while preserving muscle, reinforcing the possibility for it to be used in a broad range of cardiometabolic diseases with significant morbidity and limited treatment options."
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