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 Ozempic-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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females, age ≥18 years and ≤70 years

2. Have been diagnosed with T2D

3. Taking Ozempic (semaglutide 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

   • Participants taking metformin must be on a minimum stable dose of ≥500 mg/day
   • Participants taking Ozempic must be on a minimum stable dose of ≥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 and must be willing to have additional pregnancy tests during the study.7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.

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 GLP-1 RA other than Ozempic (semaglutide injection), dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
6. Have FPG ≥240 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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 100 mg QD in addition to their currently prescribed Ozempic (semaglutide injection)-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 56 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 icovamenib 100 mg matching placebo QD in addition to their currently prescribed Ozempic (semaglutide injection)-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 56 weeks (including screening and follow-up).

Treatment:

Drug: Placebo