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NCT06152042 (BMF-219 in Type 1 Diabetes Mellitus): BVCT ex-ante prediction vs. reported outcome

On 29 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient (hepatotoxicity).

Clinical Trial

NCTID
NCT06152042
Acronym
COVALENT-112
Drug Name
BMF-219
Drug MoA
oral small molecule MENIN inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Type 1 Diabetes Mellitus
Human Patients
190
Sponsor
Biomea Fusion
Phase
Phase 2

Prediction of , index 1492

Prospective Prediction
Prediction Index
1492
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit for T1DM patients)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
98 days in advance
Readout Data Interpretation
full clinical hold due to hepatotoxicity
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient (hepatotoxicity)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Phase 2 Randomized, Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus
Phase
Phase 2
Status
Completed
Enrollment
37
Lead sponsor
Biomea Fusion Inc.
Conditions
Type 1 Diabetes Mellitus
Interventions
DRUG: BMF-219
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2023-12-28
Primary completion
2025-05-20
Completion
2025-07-18
Primary outcomes
  • To assess the effect on endogenous insulin secretion (26 Weeks)

NCT06152042 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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