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
Biomea Fusion Inc.
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.
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 an Ozempic-based therapy will result in a greater reduction in HbA1c than Ozempic-based therapy alone. The current trial investigates participants who have used Ozempic for at least 3 months prior to screening whose HbA1c remains above the target established by the ADA.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 particip…
Interventions
- Drugicovamenib 100 mg
icovamenib 100 mg
- DrugPlacebo
Matching placebo
Locations (14)
- Central Research Associates, LLC dba Flourish ResearchBirmingham, Alabama
- Hope Clinical ResearchCanoga Park, California
- Ark Clinical ResearchLong Beach, California
- Paradigm Clinical Research Centers, LLCSan Diego, California
- Southwest General Healthcare CenterFort Myers, Florida
- Panax Clinical ResearchMiami Lakes, Florida