Enobosarm + semaglutideOral tablet · Daily tablet + weekly injection
Phase 2U.S. PLATEAU study fully enrolled; results pending
← Therapy pipeline
Investigational · Obesity development
Enobosarm
Ostarine · MK-2866 · GTx-024 · VERU-024 · Veru
Oral selective androgen receptor modulator studied with semaglutide for lean-mass preservation and weight reduction in older adults with obesity.
Androgen receptor
Other study areas
Body compositionWeight maintenance / switching
Selected program areas, not approvals. See the full profile for individual trials.Obesity stagePhase 2
Phase 1Phase 2Phase 3Regulatory review
Updated as of November 2026SponsorVeru
TargetsAndrogen receptor
RouteOral tablet
DevelopmentObesity-specific
Selected study results
QUALITY · 16-week pooled body-composition resultsBody composition during weight management1.2% · 16 weeks · Phase 2b
Phase 2b · Oral · Sponsor-reported results
Lean-mass loss by DXA · primary endpoint · 16 weeks
Less lean-mass loss; similar scale-weight loss in this pooled comparison.
Adults aged ≥60 with obesity or overweight and a weight-related condition · Enobosarm 3 mg or 6 mg daily, pooled; both groups received semaglutide · Trial N=168 · Sponsor-reported descriptive mean changes; pooled efficacy sample 100 active versus 48 placebo; adjusted primary comparison p=0.002. Results & methods ↗
| Measure | Enobosarm + semaglutide | Placebo + semaglutide |
|---|---|---|
| DXA lean mass | −1.2% | −4.1% |
| DXA fat mass | −10.9% | −8.6% |
| Body weight | −4.4 kg | −4.7 kg |
| Participants with ≥10% stair-climb-power decline | 19.4% (98 evaluated) | 42.6% (47 evaluated) |
Additional results or analyses from this same study
- Statistical interpretationThe fat-mass comparison had p=0.096; the stair-climb responder comparison had p=0.0049. Table values are descriptive means, while the sponsor’s statistical comparisons used adjusted models. The pooled analysis combines two doses and is not an estimate for 3 mg alone.
- 12-week extension after semaglutide withdrawalWeight regain during the extension was 1.41% with 3 mg, 2.87% with 6 mg and 2.57% with placebo; the 3-mg comparison had p=0.038. These are changes after withdrawal, not total weight loss from the original study baseline. Follow-up source ↗
- Safety disclosureALT elevations were more frequent at 6 mg. See the safety context below and the sponsor’s separate safety report. Follow-up source ↗
The relative reduction in lean-mass loss is not a weight-loss percentage. DXA lean mass is not identical to skeletal muscle or strength. Short-term findings in older adults should not be generalized to all GLP-1 users; PLATEAU must establish longer-term weight and functional outcomes.
Each graphic shows results within one study. Alternate analyses and follow-up from that study are labeled together. Study averages are not individual predictions or cross-trial comparisons.
Safety context
In QUALITY, the sponsor reported mild ALT elevations in 0/56 placebo recipients, 1/56 receiving 3 mg and 6/56 receiving 6 mg. No Hy’s-law liver injury or treatment-related serious adverse events were reported in that disclosure. These short-term findings do not establish long-term safety; the subsequent PLATEAU study uses 3 mg.
Mechanism at a glance
GLP-1GLP-1—
GIPGIP—
GCGglucagon—
AMYamylin—
OTHOther targetsTargeted
Body-composition and other targets appear alongside hormone pathways in this overview.
Explore the hormone anatomy ↗Obesity stage by formulation
Milestone → next
Latest: The Phase 2b PLATEAU trial has enrolled 239 participants. Earlier QUALITY results showed less lean-mass loss, with similar scale-weight loss in the pooled 16-week comparison.
Next: Sponsor expects PLATEAU interim DXA results in Q1 2027 and final topline results in Q4 2027; these are anticipated dates, not reported outcomes.
Clinical study records
Obesity and weight-management studies appear first. Related-condition trials follow by phase, with focus labels to show what each study evaluates. Study stage and results reporting are listed separately. Results summarized above are identified as peer-reviewed or sponsor reported. Otherwise, the label states whether results were posted to a registry or reported in the linked source.
Obesity and weight-management studies
Phase 2 studies2 records
PLATEAU
Weight managementStudy: OngoingResults: Phase 2b results pendingStatus reviewed November 2026
U.S. randomized, blinded study in 239 adults aged 65 or older with BMI ≥35. Enobosarm 3 mg daily or oral placebo, each with weekly semaglutide, for 68 weeks. Primary endpoint: percent body-weight change at week 68; body composition and physical function are additional measures. Registry remains active, not recruiting (last update September 4, 2026).
QUALITY
Weight managementStudy: CompletedResults: Sponsor-reported 16-week and extension results shown aboveStatus reviewed November 2026
Completed U.S. randomized study in 168 adults aged 60 or older with obesity or overweight plus a weight-related condition. Enobosarm 3 mg, 6 mg or placebo daily with semaglutide for 16 weeks; primary endpoint: DXA lean-mass change. A further 12-week extension stopped semaglutide and continued the assigned oral treatment. Sponsor results are available; no registry results posted at this check.