Veru, the company developing enobosarm (ostarine, MK-2866), says its Phase 2b PLATEAU trial of enobosarm with semaglutide is fully enrolled. The trial is testing whether adding enobosarm 3 mg to semaglutide (the drug in Wegovy) helps older adults with obesity keep muscle and break through the weight-loss plateau. About 200 people aged 65 or older with a BMI of 35 or more, who are starting semaglutide, have been randomized to enobosarm or placebo. Interim results are expected in the first quarter of 2027, according to the company.
What the trial tests
| Design | Phase 2b, double-blind, placebo-controlled |
|---|---|
| People | About 200 adults aged 65+ with BMI 35 or more, starting semaglutide |
| Treatment | Enobosarm 3 mg vs placebo, on top of semaglutide |
| Main goal | Percent change in total body weight at 68 weeks |
| Key secondary goals | Fat mass, lean mass, physical function (stair climb), mobility, bone density, HbA1c and insulin resistance |
| Timeline (company) | First patient March 2026; fully enrolled 27 July 2026; interim DXA results (32 weeks) Q1 2027; topline Q4 2027 |
Veru also said that in June 2026 it signed a clinical supply agreement with Novo Nordisk, the maker of Wegovy, for the trial.
Why weight loss is now the main goal
The trial’s main endpoint is extra weight loss, not lean mass. In September 2025, Veru said the FDA had told it that incremental weight loss with enobosarm on top of a GLP-1 drug, compared with the GLP-1 drug alone, would be an acceptable primary endpoint to support approval, and that 3 mg was an acceptable dose. That is the company’s account of the meeting; the FDA does not publish such feedback.
What came before: the QUALITY trial
PLATEAU follows the Phase 2b QUALITY trial in 168 adults over 60 on semaglutide. In its January 2025 topline report, Veru said enobosarm cut lean-mass loss by 71% compared with semaglutide alone over 16 weeks (p=0.002) and increased fat loss by 27% (p=0.096, not statistically significant), with similar total weight loss. Those results have not yet been published in a peer-reviewed journal. We covered them in ostarine preserves muscle on Wegovy and Ozempic.
What it means
Enobosarm is still not approved anywhere, and PLATEAU will not report until 2027. It is the most advanced attempt to turn a SARM into an approved drug: earlier, two Phase 3 trials in lung cancer missed their main goals, and a Phase 3 breast cancer trial was stopped in 2024 for business reasons. The safety signals from earlier trials still apply: lower total testosterone, SHBG and HDL cholesterol, dose-dependent liver-enzyme rises, and case reports of liver injury with ostarine bought online. See the ostarine fact sheet.
Frequently asked questions
Is enobosarm the same as ostarine?
YesEvidence: Law
Enobosarm is the official name for ostarine (also MK-2866), a SARM developed by GTx and now by Veru.
When will PLATEAU results be available?
2027 (company timeline)Evidence: Limited
Veru expects interim body-composition results in the first quarter of 2027 and topline results in the fourth quarter of 2027.
Is enobosarm approved for weight loss?
NoEvidence: Law
It is still not approved anywhere; it is in a Phase 2b trial with semaglutide that will not report until 2027.
What did the earlier QUALITY trial find?
Less lean-mass loss (company data)Evidence: Trial
In a company topline report, enobosarm with semaglutide cut lean-mass loss by 71% vs semaglutide alone over 16 weeks; the extra fat loss was not statistically significant. It has not been published in a journal.
Sources
- Veru Announces Full Enrollment for Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss (press release, 27 July 2026)
- Veru Enrolls First Patient in Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination (press release, 9 March 2026)
- Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 RA (press release, 23 September 2025)
- Veru Announces Positive Topline Data from Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass in Patients Receiving WEGOVY (Semaglutide) for Weight Reduction (press release, 27 January 2025)
- ClinicalTrials.gov NCT06282458: Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 (QUALITY)
- The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial
- GTx, Inc. Provides Corporate Update And Reports 2013 Financial Results (press release, 4 March 2014)
- ClinicalTrials.gov NCT04869943: Efficacy Evaluation of Enobosarm Monotherapy in AR+/ER+/HER2- Metastatic Breast Cancer (ARTEST, Phase 3, terminated)