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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 who are not achieving glycemic targets despite antihyperglycemic medications.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Males or females, age ≥18 years and ≤75 years 2. Diagnosed with T2D 3. Have been treated with lifestyle management with 1 to 3 antihyperglycemic medications: metformin, SGLT2i, alogliptin, or sitagliptin with a stable dose 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) 4. Have HbA1c ≥7.5 and ≤10.5% 5. Have a BMI ≤32 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, and 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.

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 positive GAD autoantibody result within 60 days prior to screening 4. 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 5. Have personal or family history (first-degree relative) of MEN1 6. Use of GLP-1 RA, dual GIP/GLP-1 RA, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, [linagliptin, saxagliptin (these 2 are drugs within DPP-4i class)], bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin in the 3 months prior to screening 7. Have fasting triglyceride ≥500 mg/dL 8. Have an eGFR <60 mL/min/1.73 m2 by the CKD-EPI Creatinine Equation at screening 9. Have impaired liver function, defined as screening AST or ALT >1.2×ULN, and/or total bilirubin >ULN

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 antihyperglycemic medication(s). Treatment with icovamenib or placebo will last for 12 weeks. At Week 12, participants in each treatment arm will continue on their currently prescribed antihyperglycemic medication(s). 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 		icovamenib 100 mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks
  • Drug: icovamenib 100mg
    icovamenib 100mg
Placebo Comparator
Arm B: placebo matching 100 mg 		placebo matching 100mg QD in addition to their currently prescribed antihyperglycemic medication(s) for 12 weeks. At Week 12, participants will continue on their currently prescribed antihyperglycemic medication(s). The total duration of the trial is approximately 56 weeks
  • Drug: Placebo
    Matching placebo

Recruiting Locations

Central Research Associates, LLC dba Flourish Research
Birmingham, Alabama 35205

Hope Clinical Research
Canoga Park, California 91303

Ark Clinical Research
Fountain Valley, California 92708

Ark Clinical Research
Long Beach, California 90815

Catalina Research Institute, LLC
Montclair, California 91763

Paradigm Clinical Research Centers, LLC
San Diego, California 92108

Southwest General Healthcare Center
Fort Myers, Florida 33907

Panax Clinical Research
Miami Lakes, Florida 33014

Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida 32789

David Kavtaradze MD, Inc
Cordele, Georgia 31015

Excel Clinical Research
Las Vegas, Nevada 89109

Diabetes and Endocrinology Associates of Stark County
Canton, Ohio 44718

Elligo Health Research, Inc.
Austin, Texas 78704

Zenos Clinical Research
Dallas, Texas 75230

Synergy Groups Medical
Houston, Texas 77061

Epic Clinical Research
Lewisville, Texas 75057

Synergy Group Medical LLC
Missouri City, Texas 77459

Manassas Clinical Research Center
Manassas, Virginia 20110

More Details

Status
Recruiting
Sponsor
Biomea Fusion Inc.

Study Contact

Biomea Fusion Inc.
1-844-245-0490
clinicaltrials@biomeafusion.com

Detailed Description

This study is a 52-week, Phase 2 trial is designed to examine whether treatment with icovamenib in participants with T2D who are currently on standard-of-care antihyperglycemic medications (metformin, SGLT2 inhibitor, alogliptin, or sitagliptin) plus lifestyle management will result in a greater reduction in HbA1c than those therapies alone. The trial investigates participants who have been on a stable dose of their antihyperglycemic medication(s) for at least 3 months prior to screening whose HbA1c remains above the target established by the American Diabetes Association (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.