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NCT06282458 (Enobosarm in Muscle Loss Obesity): BVCT ex-ante prediction vs. reported outcome

On 13 Oct 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 27 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially maybe insufficient (weak efficacy).

Clinical Trial

NCTID
NCT06282458
Acronym
QUALITY
Drug Name
Enobosarm
Drug MoA
nonsteroidal selective androgen receptor modulator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Muscle Loss Obesity
Human Patients
150
Sponsor
Veru
Phase
Phase 2

Prediction of , index 1717

Prospective Prediction
Prediction Index
1717
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit with inferior-to-semaglutide reduction in total fat mass)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in lowering the reduction of total lean body mass with the toxicity of weakening muscle strength)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
106 days in advance
Readout Data Interpretation
Enobosarm achieved a placebo-adjusted 2.9% reduction of muscle loss (p=0.002) superior to semaglutide; yet a placebo-adjusted 2.3% improvement of fat loss (p=0.096) non-superior to semaglutide; and a placebo-adjusted 0.3kg less weight loss slightly inferior to semaglutide
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially maybe insufficient (weak efficacy)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2 Dose-Finding and Proof-of-Concept Study to Evaluate the Effect on Body Composition and Safety of Enobosarm in Patients Treated With Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists for Chronic Weight Management
Phase
Phase 2
Status
Completed
Enrollment
168
Lead sponsor
Veru Inc.
Conditions
Muscle Loss; Obesity
Interventions
DRUG: Enobosarm; DRUG: Semaglutide
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2024-04-29
Primary completion
2025-04-11
Completion
2025-08-22
Primary outcomes
  • The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. (Day 112)

NCT06282458 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials