Veru announces first patients enrolled in phase 2b trial for weight loss treatment

Betsy Goodfellow | May 1, 2024 | News story | Research and Development Obesity, Veru, Wegovy, enobosarm, weight loss 

Veru has announced that it has enrolled the first patients into its phase 2b clinical trial of enobosarm, an oral selective androgen receptor modulator (SARM), to avoid muscle loss and to augment fat loss in combination with Wegovy (semaglutide).

The phase 2b, multi-centre, double-blind, placebo-controlled, randomised, dose-finding trial has the aim of assessing the safety and efficacy of enobosarm in 3mg and 6mg doses compared to a placebo. Its primary endpoint is the difference in total lean body mass measured by DEXA, with key secondary endpoints being differences in total body fat mass measured by DEXA and physical function measured by a stair climb test at 16 weeks.

Results from the trial are expected in the fourth quarter of 2024.

Mitchell Steiner MD, chairman, president and chief executive officer of Veru, commented: “We are excited to enrol the first patients in the phase 2b clinical trial, marking an important milestone in the development of enobosarm for high quality weight loss. There is a significant unmet medical need to have a drug that may effectively preserve muscle in patients undergoing weight loss therapy with GLP-1 drugs. Patients receiving GLP-1 drugs lose significant muscle as part of the weight loss which can lead to muscle weakness in older patients with both obesity and low muscle reserves. Muscle weakness is associated with mobility disability and loss of balance resulting in a higher risk for falls and hip and pelvic fractures. In fact, the package insert for Wegovy has been updated based on the recently reported SELECT (Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity) cardiovascular outcomes clinical trial to highlight the four-fold increase in pelvic and hip fractures that was observed in patients greater than 75 years of age receiving Wegovy compared to placebo.”

Betsy Goodfellow

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