← Trials/Trial dossier/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
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
Asset
Semaglutide
GLP-1 agonist
Listed sites
16
Recruiting sites
16
Enrollment
60
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI 25-40•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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
Glycemic / diabetes
4 endpointsTo 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
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
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
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 endpointsTo compare the safety and tolerability of icovamenib versus placebo
Time frame:52 weeks
Treatment-emergent AEs (any)
event count, event
To compare the safety and tolerability of icovamenib versus placebo
Time frame:16 weeks
Treatment-emergent AEs (any)
event count, event
To compare the safety and tolerability of icovamenib versus placebo
Time frame:52 weeks
Serious AEs (any)
event count, event
To compare the safety and tolerability of icovamenib versus placebo
Time frame:12 weeks
Discontinuation due to AE
event count, event
To characterize the pharmacokinetics of icovamenib
Time frame:10 weeks
AUC₀–∞
concentration, descriptive
To characterize the pharmacokinetics of icovamenib
Time frame:10 weeks
Cmax
concentration, descriptive
Provenance
Sources
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.