NCT07502508

Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy

Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Biomea Fusion Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite Ozempic-based therapy.

Detailed description

This study is a 52-week, phase 2 trial designed to examine whether treatment with icovamenib in participants with T2D who are currently on an Ozempic-based therapy will result in a greater reduction in HbA1c than Ozempic-based therapy alone. The current trial investigates participants who have used Ozempic for at least 3 months prior to screening whose HbA1c remains above the target established by the ADA.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	icovamenib 100 mg	icovamenib 100 mg
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2026-03-31
• Last updated: 2026-04-08

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study