BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04963231 (Setmelanotide in 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 4 Nov 2024 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
NCT04963231
Acronym
DAYBREAK
Drug Name
Setmelanotide
Drug MoA
MC4R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Hypothalamic Obesity
Human Patients
164
Sponsor
Rhythm Pharmaceuticals
Phase
Phase 2

Prediction of , index 1330

Prospective Prediction
Prediction Index
1330
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
350 days in advance
Readout Data Interpretation
setmelanotide achieved 55% placebo-adjusted higher proportion of patients who achieved 5% BMI reduction
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 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway
Phase
Phase 2
Status
Completed
Enrollment
164
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Conditions
Genetic Obesity
Interventions
DRUG: Setmelanotide; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2021-11-30
Primary completion
2023-08-04
Completion
2024-09-30
Results first posted
2024-10-24
Primary outcomes
  • Stage 1: Number of Participants by Genotype Who Demonstrated a Significant Clinically Meaningful Response to Setmelanotide at the End of Stage 1 (Baseline to Week 16)

NCT04963231 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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