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NCT05093634 (Setmelanotide in rare, genetically-driven obesities of the MC4R…): BVCT ex-ante prediction vs. reported outcome

On 20 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 Mar 2026 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05093634
Acronym
EMANATE
Drug Name
Setmelanotide
Drug MoA
MC4R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
rare, genetically-driven obesities of the MC4R pathway
Human Patients
296
Sponsor
Rhythm Pharmaceuticals
Phase
Phase 3

Prediction of , index 1331

Prospective Prediction
Prediction Index
1331
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
847 days in advance
Readout Data Interpretation
setmelanotide failed to achieve placebo-adjusted statistically significant BMI reduction at week 52 in the modified IIT population
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of setmelanotide’s MoA for MC4R-mutant-driven obesity that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients With POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway
Phase
Phase 3
Status
Completed
Enrollment
296
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Conditions
Obesity; Genetic Obesity
Interventions
DRUG: Setmelanotide; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-12-10
Primary completion
2025-12-22
Completion
2026-06-30
Primary outcomes
  • Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMI (Baseline to 52 weeks)

NCT05093634 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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