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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts 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 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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).
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: icovamenib 100 mg 		Starting on Day 1, participants will receive icovamenib 100 mg QD in addition to their currently prescribed Ozempic (semaglutide injection)-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 56 weeks (including screening and follow-up)
  • Drug: icovamenib 100 mg
    icovamenib 100 mg
Placebo Comparator
Arm B: matching placebo 100 mg 		Starting on Day 1, participants will receive icovamenib 100 mg matching placebo QD in addition to their currently prescribed Ozempic (semaglutide injection)-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 56 weeks (including screening and follow-up).
  • Drug: Placebo
    Matching placebo

Recruiting Locations

Hope Clinical Research
Canoga Park, California 91303

Ark Clinical Research
Long Beach, California 90815

Southwest General Healthcare Center
Fort Myers, Florida 33907

Panax Clinical Research
Miami Lakes, Florida 33014

Synergy Group Medical
Houston, Texas 77061

Alliance Clinical Lewisville
Lewisville, Texas 75057

More Details

Status
Recruiting
Sponsor
Biomea Fusion Inc.

Study Contact

Biomea Fusion Inc.
8442450490
clinicaltrials@biomeafusion.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.