Rivus Pharmaceuticals Unveils Promising Phase 2a Results for HU6 in Obesity-Related Heart Failure Patients
Clinical Trial Success:
Rivus Pharmaceuticals' Phase 2a HuMAIN trial of HU6 in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) met its primary endpoint, demonstrating statistically significant weight loss.
Weight Loss Data:
Patients taking 450 mg of HU6 experienced significant weight loss from baseline (-6.8 pounds, p<0.0001) and compared with placebo-treated patients (-6.3 pounds, p=0.003).
Fat-Selective Weight Loss:
HU6 treatment resulted in significant reductions in fat mass and visceral fat, with no change in lean body mass, indicating fat-selective weight loss.
Secondary Endpoints:
The trial also showed improvements in secondary efficacy endpoints, including systolic and diastolic blood pressure, and markers of atherosclerotic cardiovascular disease.
Safety Profile:
HU6 was generally well tolerated, with side effects mainly mild or moderate in severity, in a patient population with advanced disease and multiple comorbidities.
Future Development:
Rivus plans to engage with regulatory authorities for a Phase 3 study in obesity-related HFpEF in 2025, following the successful Phase 2a results.
Mechanism of Action:
HU6, a controlled metabolic accelerator (CMA), works by safely leveraging mitochondrial uncoupling to promote sustained body fat loss while preserving muscle mass.