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RecruitingPhase 2

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

Lead sponsor

Biomea Fusion Inc.

Asset

Semaglutide

GLP-1 agonist

Listed sites

16

Recruiting sites

16

Enrollment

60

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI 25-40HbA1c 7.5-9.5%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07502508
Org study IDCOVALENT-212

Timeline

Milestones

Study first posted2026-03-31actual
Last update posted2026-05-12actual
Study start2026-04estimated (month precision)
Primary completion2027-06estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Key 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

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.

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 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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Glycemic / diabetes
4

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

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

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period

Time frame:26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

To compare the safety and tolerability of icovamenib versus placebo

Time frame:52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

To compare the safety and tolerability of icovamenib versus placebo

Time frame:16 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

To compare the safety and tolerability of icovamenib versus placebo

Time frame:52 weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

To compare the safety and tolerability of icovamenib versus placebo

Time frame:12 weeks

Discontinuation due to AE

event count, event

Other/protocol endpoint

To characterize the pharmacokinetics of icovamenib

Time frame:10 weeks

AUC₀–∞

concentration, descriptive

Other/protocol endpoint

To characterize the pharmacokinetics of icovamenib

Time frame:10 weeks

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.