Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes
Brief 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.
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 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.
Interventions
DRUGicovamenib 100 mg
icovamenib 100 mg
DRUGPlacebo
Matching placebo
Sponsors
Biomea Fusion Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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 28 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 Ozempic (semaglutide injection)-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 Ozempic-based regimen. The total duration of the trial is approximately 56 weeks (including screening and follow-up).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control | 26 weeks | Mean change in HbA1c from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control | 12 weeks | Mean change in HbA1c from baseline |
| To compare the change in fasting plasma glucose with icovamenib versus placebo during the off-treatment Follow-up Period | 26 weeks | Mean change in fasting plasma glucose from baseline |
| To compare the safety and tolerability of icovamenib versus placebo | 52 weeks | Incidence of AEs |
Countries
United States
Contacts
CONTACTBiomea Fusion Inc.
Outcome results
None listed