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NCT05731544 (BMF-219 in Type 2 Diabetes Mellitus): BVCT ex-ante prediction vs. reported outcome

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

Clinical Trial

NCTID
NCT05731544
Acronym
COVALENT-111
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 2 Diabetes Mellitus
Human Patients
414
Sponsor
Biomea Fusion
Phase
Phase 1 Phase 2

Prediction of , index 1047

Prospective Prediction
Prediction Index
1047
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit for T2DM patients)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
6 days in advance
Readout Data Interpretation
-0.4% to -1.4% HbA1c at week 26; which is inferior to tirzepatide's -1.6 to -2.4% HbA1c at week 26; full clinical hold due to hepatotoxicity
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, PK, and PD of BMF-219, an Oral Covalent Menin Inhibitor, in Healthy Adults and Adults With T2D
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
443
Lead sponsor
Biomea Fusion Inc.
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG: BMF-219
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-08-17
Primary completion
2024-11-18
Completion
2025-07-08
Primary outcomes
  • Safety Assessments (52 weeks)
  • Pharmacokinetics Assessments (12 weeks)
  • Change in HbA1c (26 weeks)

NCT05731544 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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