Rivus Pharmaceuticals has released data showing the muscle-sparing benefit of its weight loss drug in a Phase IIa in obese patients with heart failure with preserved ejection fraction (HFpEF).
Patients treated with HU6 saw statistically significant reductions in fat mass and visceral fat, with no change in lean body mass in the HU6 450mg dose. Muscle-sparing is particularly important in patients with heart failure and can be linked to increased mortality.
In August, the company announced the Phase IIa HuMAIN trial (NCT05284617), evaluating HU6 in patients with obesity-related HFpEF, met its primary endpoint of statistically significant weight loss.
The trial also showed benefit in several key secondary endpoints, including systolic and diastolic blood pressure, and key markers of atherosclerotic cardiovascular disease as well as in echo and MRI measures of cardiac structure and function.
The Phase IIa, double-blind, placebo controlled, dose escalation trial, enrolled 67 patients across 15 sites in the US.
Dr. Ambarish Pandey, 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) Annual Scientific Meeting 2024 in Atlanta.
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 versus placebo, as well as a trend toward improvement in the 6-minute walk distance (6MWD). HU6 was generally well tolerated, consistent with previous studies.
HU6 is a novel, oral, once-daily, potentially first-in-class investigational treatment which promotes sustained body fat loss while preserving muscle mass.
The weight loss field is heavily dominated by Novo Nordisk’s Weogovy/Ozempic (semaglutide) and Eli Lilly’s Zepbound/Mounjaro (tirzepatide), which are both glucagon-like peptide-1 receptor agonists.
GlobalData predicts GLP-1 sales to reach $125bn by 2033 in both obesity and type 2 diabetes. The drugs are also being investigated in other indications considered to be associated with the metabolic diseases including cardiac and respiratory conditions.
