Veru's enobosarm muscle study closes enrollment in GLP-1 users

Veru Inc. says its study of the experimental drug enobosarm in people taking a GLP-1 receptor agonist for weight loss is fully enrolled, and a registry tracker shows the trial's status changing from "recruiting" to "active, not recruiting" on September 4, 2026, along with a change to its enrollment figure ^[1]. The listing is a Phase 2 proof-of-concept study of enobosarm in patients treated with a GLP-1 receptor agonist for weight loss, sponsored by Veru ^[1].

At the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 9, 2026, Veru management said the Phase IIb QUALITY trial enrolled 239 patients over 60 who were starting semaglutide for the first time, and that an ongoing PLATEAU trial is also fully enrolled with 239 patients and designed to run 68 weeks ^[2]. It has not been reported whether those company descriptions refer to the same study as the registry entry that changed status ^[1][2].

What the company reported

In QUALITY, patients were assigned to 3-milligram enobosarm, 6-milligram enobosarm or placebo, and all received semaglutide ^[2]. During a 16-week weight-loss period, the 3-milligram dose preserved lean mass while patients lost weight, and management said the weight lost was made up entirely of fat ^[2]. The 6-milligram dose did not add more muscle preservation but did produce greater fat loss ^[2]. Veru said the 3-milligram dose was chosen for future work because of its safety profile and the larger clinical database behind it ^[2].

On function, Veru said 44% of patients taking semaglutide plus placebo had more than a 10% decline in stair climb power at 16 weeks, and that adding 3-milligram enobosarm reduced that incidence by up to 60%, a result management called highly statistically significant ^[2]. The company said a 10% decline in stair climb power is roughly equal to seven to eight years of natural age-related decline ^[2].

On safety, Veru said one patient on the 3-milligram dose had a threefold increase in ALT, a liver enzyme, which resolved while the patient stayed on treatment; the 6-milligram group had more liver enzyme elevations but the same pattern of resolution ^[2]. The company reported no bilirubin elevations and no cases of Hy's Law, and said there were no added gastrointestinal side effects ^[2]. Veru also said enobosarm has been studied in about 2,000 patients across 27 clinical trials ^[2]. These are company statements from a conference presentation; full results from the newly enrolled study have not been released.

Why it matters for patients

Weight loss from GLP-1 drugs can include lean tissue along with fat, and Veru is betting that older adults care most about what that means for strength and daily function. Chief executive Mitch said, "The FDA is not interested in making a cosmetic statement that you held onto lean. You have to show what does that mean to the patient" ^[2].

Veru framed the market as the roughly 40 million Americans over 65, about half of whom it says could benefit from a weight-loss drug, arguing that patients in this group are more likely to lose function if they lose muscle quickly ^[2]. Whether preserving lean mass on a GLP-1 drug actually reduces falls, fractures or hospital stays has not been established by the studies described ^[2].

Enobosarm is an oral selective androgen receptor modulator, or SARM, and it is not approved for muscle preservation or any weight-related use. The findings described so far come from a Phase IIb trial reported by the company, not from a completed late-stage program ^[2].

What happens next

Veru said a PLATEAU interim analysis is scheduled for the first quarter of 2027, at the 32-week mark, measuring lean and fat mass by DEXA scans in patients over 65 with a BMI above 35 ^[2]. Management said the interim will not carry a statistical penalty because weight is not part of that readout, and described it as a "temperature check" ^[2].

The company said it expects a Phase III program of about 4,500 patients ^[2]. Veru reported about $24 million in cash as of June 30, which it said should fund operations into mid-2027 ^[2]. A U.S. patent issued September 1 covers the concurrent use of enobosarm and semaglutide through 2044, and Veru has a clinical supply agreement with Novo Nordisk that includes a first right of negotiation with a 90-day decision window ^[2].