Rivus data demonstrates muscle-sparing benefits of weight loss medications in Phase IIa

Rivius Pharmaceuticals has released data that supports claims that its weight-loss drug also has muscle-sparing benefits. Photo credit: Shutterstock / Artem Stepanov

Rivus Pharmaceuticals has published data demonstrating the muscle-sparing benefit of its weight loss drug in Phase IIa in obese patients with heart failure with preserved ejection fraction (HFpEF).

Patients treated with HU6 experienced a statistically significant reduction in fat mass and visceral fat at the HU6 dose of 450 mg, with no change in lean body mass. Muscle rest is particularly important in patients with heart failure and may be associated with increased mortality.

In August, the company announced that the Phase IIa HuMAIN trial (NCT05284617), evaluating HU6 in patients with obesity-related HFpEF, met its primary endpoint of statistically significant weight loss.

The study also showed benefits in several key secondary endpoints, including systolic and diastolic blood pressure and key markers of atherosclerotic cardiovascular disease, as well as echo and MRI measurements of cardiac structure and function.

The Phase IIa, double-blind, placebo-controlled, dose-escalation study enrolled 67 patients at 15 sites in the United States.

Dr. Ambarish Pandey, a cardiologist and trial investigator at the University of Texas Southwestern Medical Center, presented the data during a Late Breaking Clinical Trial Plenary Session at the Heart Failure Society of America (HFSA) 2024 Annual Scientific Meeting in Atlanta.

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Data showed a trend toward improvement in inflammation in the intention-to-treat (ITT) population, with a 3 mg/L improvement in high-sensitivity C-reactive protein (CRP) in the HU6-treated population compared to placebo, as well as a trend toward improvement in 6-minute walk distance (6MWD). HU6 was generally well tolerated, consistent with previous studies.

HU6 is a novel, once-daily, potentially first-in-class investigational treatment that promotes sustained body fat loss while maintaining muscle mass.

The weight loss space is heavily dominated by Novo Nordisk's Weogovy/Ozempic (semaglutide) and Eli Lilly's Zepbound/Mounjaro (tirzepatide), both of which are glucagon-like peptide-1 receptor agonists.

GlobalData predicts that GLP-1 sales will reach $125 billion by 2033 in both obesity and type 2 diabetes. The drugs are also being studied in other indications suspected of being linked to metabolic diseases, including cardiac and respiratory diseases.