NCT06152042

Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

Phase 2 Randomized, Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Biomea Fusion Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.

Detailed description

Study COVALENT-112 is a 52-week, Phase 2 trial designed to examine beta-cell function, insulin sensitivity, and both glucose and lipid metabolism in participants with T1D treated with BMF-219. BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BMF-219	BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Timeline

• Start date: 2023-12-28
• Primary completion: 2025-05-20
• Completion: 2025-07-18
• First posted: 2023-11-30
• Last updated: 2025-09-10

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study