Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

Biomea Fusion

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: icovamenib 100mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07502495

COVALENT-211

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 who are not achieving glycemic targets despite antihyperglycemic medications.

Full description

This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (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. Diagnosed with T2D
3. Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose for at least 3 months prior to screening (participants taking metformin must be on a minimum stable dose of ≥500 mg/day)
4. Have HbA1c ≥7.5 and ≤10.5%
5. Have a BMI ≤32 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 positive GAD autoantibody result at screening
4. 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
5. Have personal or family history (first-degree relative) of MEN16. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, [linagliptin, saxagliptin (these 2 are drugs within DPP4I class)], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening
6. Have FPG ≥240 mg/dL
7. Have fasting triglyceride ≥500 mg/dL
8. Have an eGFR <75 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening
9. Have impaired liver function, defined as screening AST or ALT >1.2×ULN, and/or total bilirubin >ULN

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:

icovamenib 100 mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks

Treatment:

Drug: icovamenib 100mg

Arm B: matching placebo 100 mg

Placebo Comparator group

Description:

icovamenib 100 mg matching placebo QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks

Treatment:

Drug: Placebo