Rivus Pharmaceuticals Announces Positive Phase 2a HuMAIN Trial Results for HU6 in Obesity-Related Heart Failure with Preserved Ejection Fraction

13 March 2025 | Thursday | News

HU6 demonstrated significant reductions in body weight and visceral fat, offering potential as a transformative treatment for patients with obesity-driven HFpEF, with low rates of adverse events in the study.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Rivus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to treating cardiometabolic diseases driven by obesity, announced the publication of results of the Phase 2a HuMAIN clinical trial of HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) in JAMA Cardiology. The study met the primary endpoint of reduction in body weight with HU6 compared to placebo over the 19-week period. This reduction was driven by decreases in fat mass and visceral fat while preserving lean mass, highlighting improved body composition with HU6. Overall rates of serious adverse events (AEs) and treatment discontinuation with HU6 were low.

HU6, a novel, once-daily, oral investigational medicine, is part of Rivus' portfolio of Controlled Metabolic Accelerators (CMAs). HU6, the company's lead program, increases metabolic rate in a controlled manner enabling sustained fat loss while preserving muscle mass, the primary engine of caloric utilization in the body. Excess body fat plays a key role in the underlying pathology of HFpEF, an increasingly common disorder that affects a growing population of patients for whom few effective treatments are available.

"I am excited to see the potential of HU6 in significantly reducing visceral adiposity and total body fat without affecting lean mass in patients with obesity and HFpEF," said Ambarish Pandey, M.D., a cardiologist, lead-author of the publication and member of the HuMAIN study Steering Committee. "As we know, visceral adiposity is causally implicated in the development and progression of HFpEF and having a therapy that can directly target this could be transformative in HFpEF treatment."

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