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NCT06445075 (Apitegromab in GLP1RA-related Muscle Preservation for Overweight and…): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 18 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (85% fat mass/15% lean mass compared to tirzepatide alone (70% fat mass/30% lean mass).

Clinical Trial

NCTID
NCT06445075
Acronym
EMBRAZE
Drug Name
Apitegromab
Drug MoA
latent myostatin inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
GLP1RA-related Muscle Preservation for Overweight and Obesity
Human Patients
100
Sponsor
Scholar Rock
Phase
Phase 2

Prediction of , index 1720

Prospective Prediction
Prediction Index
1720
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in weight reduction; total lean body mass preservation; and total fat body mass reduction; superior to semaglutide/tirzepatide monotherapy)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in weight reduction; total lean body mass preservation; and total fat body mass reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
316 days in advance
Readout Data Interpretation
apitegromab achieved a placebo-adjusted 15.6% reduction of muscle loss percentage (p=0.001) at week 24 superior to tirzepatide; and a placebo-adjusted 15.8% increase of fat loss percentage at week 24 superior to tirzepatide; and a placebo-adjusted 1.1% weight gain at week 24 compared with tirzepatide
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (85% fat mass/15% lean mass compared to tirzepatide alone (70% fat mass/30% lean mass)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects
Phase
Phase 2
Status
Completed
Enrollment
102
Lead sponsor
Scholar Rock, Inc.
Conditions
Overweight and Obesity
Interventions
DRUG: Apitegromab; DRUG: Placebo; DRUG: Tirzepatide
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-05-21
Primary completion
2025-03-04
Completion
2025-06-17
Primary outcomes
  • Change from Baseline in total Lean Body Mass (kg) at 24 weeks (Baseline and 24 weeks)

NCT06445075 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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