Type 2 DiabetesPhase 2NCT07502508
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
A Phase 2 study testing icovamenib 100 mg in people with Type 2 Diabetes, run by Biomea Fusion Inc. at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- icovamenib 100 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Apr 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age ≥18 years and ≤75 years
- Have been diagnosed with T2D
- 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
- Have HbA1c ≥7.0 and ≤10.5%
- Have a BMI 25 to 45 kg/m2
- 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.
- Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
Who cannot join
- Have type 1 diabetes mellitus or a secondary form of diabetes
- Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
- 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
- Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
- 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 locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Elligo Health Research, Inc.
Austin, Texas, 78704
- Recruiting
Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama, 35205
- Recruiting
Burke Internal Medicine and Research
Burke, Virginia, 22015
- Recruiting
Hope Clinical Research
Canoga Park, California, 91303
- Recruiting
Diabetes and Endocrinology Associates of Stark County
Canton, Ohio, 44718
- Recruiting
Centricity Research, Endocrine Consultants PC
Columbus, Georgia, 31904
- Recruiting
David Kavtaradze MD, Inc
Cordele, Georgia, 31015
- Recruiting
Zenos Clinical Research
Dallas, Texas, 75230
- Recruiting
Southwest General Healthcare Center
Fort Myers, Florida, 33907
- Recruiting
Synergy Group Medical
Houston, Texas, 77061
- Recruiting
Excel Clinical Research
Las Vegas, Nevada, 89109
- Recruiting
Epic Clinical Research
Lewisville, Texas, 75057
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
- Recruiting
Panax Clinical Research
Miami Lakes, Florida, 33014
- Recruiting
Synergy Group Medical
Missouri City, Texas, 77459
- Recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
- Recruiting
Centricity Research, Lucas Research, Inc.
Morehead City, North Carolina, 28557
- Recruiting
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
- Recruiting
Paradigm Clinical Research Centers, LLC
San Diego, California, 92108
- Recruiting
Flourish Research Orlando
Winter Park, Florida, 32789
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Type 2 Diabetes
- Being tested
- icovamenib 100 mg, Placebo
- Keywords
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icovamenib 100 mgDrug
icovamenib 100 mg
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm A: icovamenib 100 mg | Experimental | 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) Receives: Drug: icovamenib 100 mg |
| Arm B: matching placebo 100 mg | Placebo comparator | 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Mean change in HbA1c from baseline
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Apr 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study uses a randomized, double-blind, placebo-controlled design with parallel assignment between 2 treatments. The trial begins with a screening period of up to 35 days. Eligible participants will be randomly assigned to 1 of 2 treatment arms using a 2:1 ratio (active to placebo). Starting on Day 1, participants will receive icovamenib 100 mg or placebo in addition to their currently prescribed GLP-1-based regimen. Treatment with icovamenib or placebo will last for 12 weeks. At Week 12, participants in each treatment arm will continue on a stable dose of their baseline GLP-1-based regimen. The total duration of the trial is approximately 57 weeks (including screening and follow-up).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomea Fusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502508
- Sponsor's protocol ID
- COVALENT-212
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07502508
- Acronym / sponsor ID
- COVALENT-212
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Biomea Fusion Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study uses a randomized, double-blind, placebo-controlled design with parallel assignment between 2 treatments. The trial begins with a screening period of up to 35 days. Eligible participants will be randomly assigned to 1 of 2 treatment arms using a 2:1 ratio (active to placebo). Starting on Day 1, participants will receive icovamenib 100 mg or placebo in addition to their currently prescribed GLP-1-based regimen. Treatment with icovamenib or placebo will last for 12 weeks. At Week 12, participants in each treatment arm will continue on a stable dose of their baseline GLP-1-based regimen. The total duration of the trial is approximately 57 weeks (including screening and follow-up).
| Arm | Type | Receives |
|---|---|---|
| Arm A: icovamenib 100 mg | Experimental | Drug: icovamenib 100 mgStarting 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) |
| Arm B: matching placebo 100 mg | Placebo comparator | Drug: PlaceboStarting 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females, age ≥18 years and ≤75 years
- Have been diagnosed with T2D
- 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
- Have HbA1c ≥7.0 and ≤10.5%
- Have a BMI 25 to 45 kg/m2
Key exclusion criteria (5 listed)
- Have type 1 diabetes mellitus or a secondary form of diabetes
- Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening
- 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
- Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| icovamenib 100 mgicovamenib 100 mg | Drug | Arm A: icovamenib 100 mg |
| PlaceboMatching placebo | Drug | Arm B: matching placebo 100 mg |
Primary outcome
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control
Time frame: 26 weeks
Mean change in HbA1c from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing icovamenib 100 mg in people with Type 2 Diabetes, run by Biomea Fusion Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biomea Fusion Inc. (8442450490, clinicaltrials@biomeafusion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.