The trial enrolled a total of 66 subjects with a BMI greater than 30kg/m² at 22 clinical sites in the US. Credit: Mihiripix/Shutterstock.

Rivus Pharmaceuticals has announced that its Phase IIa HuMAIN clinical trial of the new controlled metabolic accelerator (CMA) HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) met its primary and secondary endpoints.

The company concluded subject enrolment in the trial in January this year.

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The randomised, double-blind, placebo-controlled, parallel-group, dose-escalation trial assessed the safety, tolerability, pharmacodynamics, and pharmacokinetics of ascending doses of HU6 (150mg, 300mg, and 450mg daily) over 134 days.

It enrolled a total of 66 subjects with a BMI greater than 30kg/m² at 22 US clinical sites.

Weight reduction was the primary efficacy endpoint while secondary endpoints comprised improvements in exercise capacity, quality of life measures, variations in body composition and cardiac function/structure, and cardiometabolic dysfunction markers.

According to the findings, patients treated with HU6 experienced a statistically significant weight reduction and the therapy was well tolerated, with a favourable safety profile.

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Secondary efficacy and pharmacodynamic endpoints were also met in the trial.

Rivus is now preparing to discuss a Phase III study in obesity-related HFpEF with health authorities, aiming for a start date next year.

In addition, the company completed subject enrolment in the Phase II M-ACCEL trial of HU6 in patients with metabolic dysfunction-associated steatohepatitis (MASH), with topline results expected in the first half of 2025.

Rivus Pharmaceuticals CEO Jayson Dallas said: “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.

“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.”