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

Biomea Fusion

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: icovamenib 100 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07502508

COVALENT-212

Details and patient eligibility

About

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 GLP-1-based therapy.

Full 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 a GLP-1-based therapy will result in a greater reduction in HbA1c than GLP-1 based therapy alone. The current trial investigates participants who have used GLP-1 for at least 3 months prior to screening whose HbA1c remains above the target established by the ADA.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Males or females, age ≥18 years and ≤75 years
2. Have been diagnosed with T2D
3. Taking FDA-approved GLP-1 based therapy (administered as subcutaneous injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with a stable dose of all medications for at least 3 months prior to screening
4. Have HbA1c ≥7.0 and ≤10.5%
5. Have a BMI 25 to 45 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.

Key Exclusion Criteria:

1. Have type 1 diabetes mellitus or a secondary form of diabetes
2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
3. Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator
4. Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
5. Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

Arm A: icovamenib 100 mg

Experimental group

Description:

Starting on Day 1, participants will receive icovamenib or placebo 100 mg QD in addition to their currently prescribed GLP-1or GIP/GLP-1 RA based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of their baseline Ozempic-based regimen. The total duration of the trial is approximately 57 weeks (including screening and follow-up)

Treatment:

Drug: icovamenib 100 mg

Arm B: matching placebo 100 mg

Placebo Comparator group

Description:

Starting on Day 1, participants will receive matching placebo QD in addition to their currently prescribed GLP-1-based regimen. Treatment will last for 12 weeks. At Week 12, participants will continue on a stable dose of allowable GLP-1-based regimen. The total duration of the trial is approximately 57 weeks (including screening and follow-up).

Treatment:

Drug: Placebo