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
New Drug Trial for Type 2 Diabetes Patients on Ozempic
Plain English Summary
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy is a Phase 2 clinical trial sponsored by Biomea Fusion Inc. studying Type 2 Diabetes. This trial tests a new drug called icovamenib to see if it can help people with Type 2 Diabetes control their blood sugar better when current treatments aren't enough. It's for adults with Type 2 Diabetes who are already taking Ozempic but still have high blood sugar levels. Participants will receive either icovamenib or a placebo (a dummy pill) for 12 weeks, with regular check-ups. Alternatives include adjusting current medications, adding other diabetes drugs, or lifestyle changes. The trial aims to enroll 60 participants.
Official 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 Ozempic-based therapy.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 70 years old, have Type 2 Diabetes, and are taking Ozempic with other diabetes medications. You cannot join if you have Type 1 Diabetes, a history of severe low blood sugar, or certain other medical conditions like MEN1/MEN2. Your blood sugar levels (HbA1c) should be between 7.5% and 9.5%, and your BMI should be between 25 and 40. Women who can become pregnant must have negative pregnancy tests and agree to use contraception. This trial is studying Type 2 Diabetes, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if icovamenib lowers blood sugar more effectively than a placebo over 26 weeks, meaning it could offer a better way to manage diabetes for some patients. The specific primary outcome measures are: To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control (26 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a significant need for new treatments for Type 2 Diabetes patients who don't reach their blood sugar goals with existing therapies like Ozempic. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Type 2 Diabetes, where improved treatment options are needed.
Investor Insight
This Phase 2 trial by Biomea Fusion Inc. is a crucial step in developing a new diabetes medication, with a potential market of millions of patients worldwide who struggle with glycemic control. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of icovamenib, and how it might interact with your current medications. Participation involves regular visits for blood tests, physical exams, and taking the study drug or placebo daily. You'll need to commit to the study schedule for about 52 weeks, including follow-up visits. This trial is currently recruiting participants. The trial is being conducted at 14 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 60 participants
Interventions
- DRUG: icovamenib 100 mg — icovamenib 100 mg
- DRUG: Placebo — Matching placebo
Primary Outcomes
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control (26 weeks)
Secondary Outcomes
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control (12 weeks)
- To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control (52 weeks)
- To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period (26 weeks)
- To compare the safety and tolerability of icovamenib versus placebo (52 weeks)
- To compare the safety and tolerability of icovamenib versus placebo (16 weeks)
Full Eligibility Criteria
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 Locations
- Central Research Associates, LLC dba Flourish Research, Birmingham, Alabama, United States
- Hope Clinical Research, Canoga Park, California, United States
- Ark Clinical Research, Long Beach, California, United States
- Paradigm Clinical Research Centers, LLC, San Diego, California, United States
- Southwest General Healthcare Center, Fort Myers, Florida, United States
- Panax Clinical Research, Miami Lakes, Florida, United States
- David Kavtaradze MD, Inc, Cordele, Georgia, United States
- Excel Clinical Research, Las Vegas, Nevada, United States
- Diabetes and Endocrinology Associates of Stark County, Canton, Ohio, United States
- Elligo Health Research, Inc., Austin, Texas, United States
- ...and 4 more locations
Frequently Asked Questions
What is clinical trial NCT07502508?
NCT07502508 is a Phase 2 INTERVENTIONAL study titled "Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy." It is currently recruiting and is sponsored by Biomea Fusion Inc.. The trial targets enrollment of 60 participants.
What conditions does NCT07502508 study?
This trial investigates treatments for Type 2 Diabetes. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT07502508?
The interventions being studied include: icovamenib 100 mg (DRUG), Placebo (DRUG). icovamenib 100 mg
What does Phase 2 mean for NCT07502508?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07502508?
This trial is currently "Recruiting." It started on 2026-04. The estimated completion date is 2027-07.
Who is sponsoring NCT07502508?
NCT07502508 is sponsored by Biomea Fusion Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07502508?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT07502508 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07502508?
The primary outcome measures are: To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control (26 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07502508 being conducted?
This trial is being conducted at 14 sites, including Birmingham, Alabama; Canoga Park, California; Long Beach, California; San Diego, California and 10 more sites (United States).
Where can I find official information about NCT07502508?
The official record for NCT07502508 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07502508. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07502508 testing in simple terms?
This trial tests a new drug called icovamenib to see if it can help people with Type 2 Diabetes control their blood sugar better when current treatments aren't enough. It's for adults with Type 2 Diabetes who are already taking Ozempic but still have high blood sugar levels.
Why is this trial significant?
This trial addresses a significant need for new treatments for Type 2 Diabetes patients who don't reach their blood sugar goals with existing therapies like Ozempic.
What are the potential risks of participating in NCT07502508?
Common side effects may include nausea, vomiting, diarrhea, and headache. There is a risk of low blood sugar (hypoglycemia), especially when combined with other diabetes medications. The long-term effects of icovamenib are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07502508?
Ask your doctor about the potential benefits and risks of icovamenib, and how it might interact with your current medications. Participation involves regular visits for blood tests, physical exams, and taking the study drug or placebo daily. You'll need to commit to the study schedule for about 52 weeks, including follow-up visits. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07502508 signal from an investment perspective?
This Phase 2 trial by Biomea Fusion Inc. is a crucial step in developing a new diabetes medication, with a potential market of millions of patients worldwide who struggle with glycemic control. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive either icovamenib or a placebo (a dummy pill) for 12 weeks, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.