Veru's enobosarm GLP-1 muscle study closes enrollment above target

Veru's registry listing for its proof-of-concept study of enobosarm, taken alongside a GLP-1 receptor agonist, changed status from recruiting to active, not recruiting, and its target enrollment was revised upward from 200 to 239 participants ^[1]. The change was recorded on September 4, 2026, in the ClinicalTrials.gov record for the study ^[1].

Enobosarm is an oral selective androgen receptor modulator, or SARM, that Veru is developing to be taken with GLP-1 drugs such as semaglutide. The company says the drug is designed to be anabolic in muscle and bone while remaining catabolic in fat, so that weight lost on a GLP-1 drug comes from fat rather than lean tissue ^[2].

In an earlier Phase IIb trial that enrolled 239 patients over age 60 who were starting semaglutide for the first time, Veru tested 3-milligram and 6-milligram doses of enobosarm against placebo, with all patients also taking semaglutide ^[2]. During a 16-week weight-loss period, the 3-milligram dose preserved lean mass while patients lost weight, and the company said that weight loss was made up entirely of fat, unlike GLP-1 treatment alone, which can also reduce lean tissue ^[2]. The 6-milligram dose did not add more muscle protection but did produce more fat loss ^[2].

Veru also highlighted a functional measure called stair climb power. In that trial, 44% of patients on semaglutide plus placebo saw more than a 10% decline in stair climb power after 16 weeks, a decline the company said is roughly equivalent to seven to eight years of natural age-related decline ^[2]. Adding the 3-milligram dose of enobosarm cut the rate of that decline by up to 60%, according to the company ^[2]. On safety, Veru said there were no additional gastrointestinal side effects, one patient on the 3-milligram dose had a liver enzyme (ALT) rise that resolved while staying on treatment, and there were no bilirubin elevations or cases of Hy's Law across the study ^[2].

Why it matters for patients

Muscle loss during rapid weight loss is a known concern with GLP-1 drugs, especially for older adults who may already have less muscle mass and are more vulnerable to falls, fractures or loss of physical function ^[2]. A therapy designed to protect muscle while a GLP-1 drug reduces fat could, if it works and is eventually approved, address that concern for some patients.

But this is still investigational. Enobosarm is not approved for this or any other use, and the current study is a Phase II trial, not a completed program that has shown a drug works safely in a large, diverse population over the long term ^[1][2]. A study reaching its enrollment target and moving to "active, not recruiting" only means new patients are no longer being signed up, not that results are in or that the drug has been shown to work ^[1]. Veru said it expects a Phase III program of roughly 4,500 patients would be needed before any approval could be considered ^[2], and the company's financial position — about $24 million in cash as of June 30, enough to fund operations into mid-2027 — reflects the early-stage financing pressures common to smaller drug developers ^[2].

What happens next

Veru said an interim analysis from its longer, 68-week Phase IIb study, using DEXA scans to measure lean and fat mass, is expected in the first quarter of 2027 ^[2]. The company also said it received a U.S. patent on September 1 covering combined use of enobosarm and semaglutide through 2044, and that it has a clinical supply agreement with Novo Nordisk that gives Novo a 90-day first right of negotiation on any licensing deal involving a Novo product and enobosarm ^[2]. Whether the drug moves toward a larger Phase III trial, and what a final readout would show, is not yet known.