A few years ago, the idea of a medication for weight loss that actually works was something people could only dream of. However, with the rise of glucagon-like peptide-1 (GLP-1) inhibitors, this has become a reality. While several of these well-known treatments, like Ozempic and Mounjaro, are only indicated to treat type 2 diabetes, they are often prescribed off-label and have sister drugs (Wegovy and Zepbound, respectively) that are, in fact, indicated for chronic weight management. But regardless of what patients take them for, there is an outstanding concern: the muscle loss that often accompanies rapid weight loss. But now, there's a new treatment currently in clinical trials, which has patients losing weight without also losing muscle.
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Data from the phase 2 HuMAIN Trial was recently presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, revealing more about Rivus Pharmaceuticals' one-daily oral drug, HU6. According to a Sept. 30 press release, the latest trial met its primary endpoint, demonstrating that the treatment resulted in "statistically significant weight loss" for participants.
All 66 patients enrolled in the trial had obesity-related heart failure with preserved ejection fraction (HFpEF)—a type of heart failure that occurs with obesity. Those who took 450 mg of HU6 (the highest dose) lost 6.8 pounds in three months and experienced "fat-selective weight loss." By comparison, those taking placebo lost 6.3 pounds.
While this difference may not seem as staggering, the study also found that patients treated with HU6 experienced a "significant reduction in fat mass loss" and a significant reduction in visceral fat (belly fat found in the abdomen). Even better, those who took HU6 didn't have a reduction in lean body mass compared with those taking the placebo.
HU6 is a Controlled Metabolic Accelerator (CMA), a class of therapies specifically designed to reduce body fat while preserving muscle. To do so, HU6 increases the body's metabolism while it's at rest, helping to burn energy, mainly from fat, the press release explains.
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"The Phase 2a HuMAIN results showing significant reductions in body fat and visceral fat in patients with obesity-related HFpEF, who typically have excess fat throughout their cardiovascular system and systemic inflammation, are extremely promising given that the study participants had obesity, were older, with multiple medical conditions," Ambarish Pandey, MD, cardiologist, trial investigator, and member of the HuMAIN study Steering Committee, said in the release.
Pandey continued, “We were also encouraged to see the preservation of lean muscle mass, which is particularly important for older patients with HFpEF, who are often frail and have low muscle mass."
The positive effect didn't stop there, either. According to the press release, HU6 also improved patients' systolic and diastolic blood pressure and inflammation. The treatment was "generally well tolerated" among the study population, which was primarily elderly and obese with comorbidities. The most common treatment-emergent adverse events (TEAEs) were diarrhea, COVID-19, and shortness of breath.
