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NCT05774756 (Setmelanotide in Acquired Hypothalamic Obesity): BVCT ex-ante prediction vs. reported outcome

On 20 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 7 Apr 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05774756
Acronym
TRANSCEND
Drug Name
Setmelanotide
Drug MoA
MC4R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Acquired Hypothalamic Obesity
Human Patients
120
Sponsor
Rhythm Pharmaceuticals
Phase
Phase 3

Prediction of , index 1332

Prospective Prediction
Prediction Index
1332
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
504 days in advance
Readout Data Interpretation
setmelanotide achieved a 19.8% placebo-adjusted difference in BMI reduction at week 52 (p<0.0001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Phase
Phase 3
Status
Active not recruiting
Enrollment
143
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Conditions
Hypothalamic Obesity
Interventions
DRUG: Setmelanotide; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-04-26
Primary completion
2025-03-18
Completion
2027-04-16
Results first posted
2026-05-29
Primary outcomes
  • Pivotal Cohort: Mean Percent Change From Baseline in Body Mass Index (BMI) After 52 Weeks on a Therapeutic Regimen (Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks))

NCT05774756 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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