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Phase 2 Icovamenib for Type 2 Diabetes Not Meeting Glycemic Targets

This study is testing a drug called icovamenib (100 mg) to see if it can help people with Type 2 Diabetes (T2D) better control their blood sugar. You might be able to join if you are between 18 and 70 years old, have T2D, and are currently taking Ozempic (semaglutide injection) but your blood sugar levels are still too high. The main goal is to see if icovamenib is better than a placebo (an inactive substance) at improving blood sugar control after 12 weeks, with results measured at 26 weeks. The study is currently unclear about its recruitment status.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 26 weeks to measure the primary outcome.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Biomea Fusion Inc.
~60 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:icovamenib 100 mgPlacebo

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Measured over 26 weeks

Conditions

Type 2 Diabetes

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

17 sites across 8 states
Texas5
California4
Florida3
Alabama1
Georgia1
Nevada1
Ohio1
Virginia1

Who to contact

Biomea Fusion Inc.
[email protected]
8442450490
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

If participants are taking metformin, they must be on a minimum stable dose of ≥500 mg/day
Participants must be on a minimum stable dose of Ozempic ≥0.5 mg/week 4. Have HbA1c ≥7.5 and ≤9.5% 5. Have a BMI 25 to 40 kg/m2 6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, must agree to the sex and contraception requirements. 7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

What this trial measures

  • To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control26 weeks

    Mean change in HbA1c from baseline