16 September 2026 editorial review · Trial
COVALENT-112: icovamenib (oral menin inhibitor) in type 1 diabetes: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Current registry now completed August 28, with 37 actual participants; previously terminated status corrected throughout. Prior five-person uncontrolled sponsor signal retained with limitations; no posted outcome tables or confirmatory efficacy implied.
Registry: NCT06152042; COMPLETED; updated 2026-08-28; enrollment 37 (ACTUAL); results not posted.
Endpoint comparison: To assess the effect on endogenous insulin secretion (26 Weeks).
Sources for this record: COVALENT-112: BMF-219 in participants with type 1 diabetes (NCT06152042) (registry); Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes (manufacturer); Biomea Fusion Presents New Clinical and Translational Data for Icovamenib at the ADA 86th Scientific Sessions (conference); Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold (manufacturer); FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials (manufacturer).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.