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Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06152042
Recruitment Status : Suspended (Clinical Hold by the US FDA)
First Posted : November 30, 2023
Last Update Posted : June 18, 2024
Sponsor:
Information provided by (Responsible Party):
Biomea Fusion Inc.

Brief Summary:
Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: BMF-219 Phase 2

Detailed Description:
Study COVALENT-112 is a 52-week, Phase 2 trial designed to examine beta-cell function, insulin sensitivity, and both glucose and lipid metabolism in participants with T1D treated with BMF-219. BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: COVALENT-112 consists of two parts. Part 1 is a single-arm, open-label study; Part 2 is a randomized, double-blind, placebo-controlled study. Both will enroll adults with Stage 3 T1D (HbA1c ≥6.5 and ≤ 10.0%).
Primary Purpose: Treatment
Official Title: Phase 2 Randomized, Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus
Actual Study Start Date : December 28, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Part 1

Part 1 uses a randomized, open-label design with parallel assignment between 2 treatment arms in each cohort. The Part 1 Eligible participants will be randomly assigned by cohort to 1 of 2 treatment arms:

  • Cohort 1: Participants with T1D diagnosed within 3 years with C-peptide concentration ≥0.2 nmol/L
  • Arm A: BMF-219 100 mg QD for 12 weeks
  • Arm B: BMF-219 200 mg QD for 12 weeks
  • Cohort 2: Participants with T1D diagnosed between 3 to 15 years with C-peptide concentration ≥0.08 nmol/L.
  • Arm A: BMF-219 100 mg QD for 12 weeks
  • Arm B: BMF-219 200 mg QD for 12 weeks
Drug: BMF-219
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Experimental: Part 2

Part 2

Part 2 uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. Eligible participants will be randomly assigned to 1 of 3 arms using a 1:1:1 ratio:

  • Arm A: BMF-219 100 mg QD for 12 weeks
  • Arm B: BMF-219 200 mg QD for 12 weeks
Drug: BMF-219
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Placebo Comparator: Placebo Comparator
Part 2 Study Double Blind Arm C matching placebo for 12 weeks.
Drug: BMF-219
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.




Primary Outcome Measures :
  1. To assess the effect on endogenous insulin secretion [ Time Frame: 26 Weeks ]
    Mean change from baseline in stimulated C-peptide AUC.


Secondary Outcome Measures :
  1. To assess the effect on endogenous insulin secretion [ Time Frame: 26 Weeks ]
    Maximum stimulated C-peptide: the highest value at any time point during the 4-hour MMTT.

  2. To assess the effect on additional glycemic parameters [ Time Frame: 26 Weeks of treatment ]
    Mean change from baseline in HbA1c.

  3. To assess the effect on additional glycemic parameters [ Time Frame: 26 Weeks ]
    Mean change from baseline in FPG.

  4. To assess hypoglycemia events [ Time Frame: 26 weeks ]
    Percentage of participants with hypoglycemic episodes (with confirmed self-plasma glucose monitoring) including level 2 hypoglycemic events (<54 mg/dL regardless of symptoms) and level 3 (severe) hypoglycemia across different timepoints.

  5. To assess the effect on insulin doses [ Time Frame: 26 Weeks ]
    Change from baseline in mean daily insulin dosing.

  6. Rate of symptomatic hypoglycemic episodes [ Time Frame: 26 Weeks and during study duration ]
    Evaluation and comparison of the number of symptomatic (both minor and severe) hypoglycemic episodes with BMF-219 vs placebo during the study.

  7. Incidence of adverse events [ Time Frame: 26 Weeks and during study duration ]
    Evaluation and comparison of the number of adverse events with BMF-219 vs placebo during the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, age ≥18 and ≤70 years.
  2. Diagnosed with stage 3 T1D within the following timeframes:

    • Part 1 Cohort 1: Participants diagnosed within 3 years prior to screening.
    • Part 1 Cohort 2: Participants diagnosed between 3 to 15 years prior to screening
    • Part 2 : Participants diagnosed within 15 years prior to screening.
  3. Treated with insulin only for at least 2 months prior to screening and proficient in the following in the opinion of the investigator:

    • Counting carbohydrates
    • Adjusting meal and correction boluses based on glucose readings with a stable insulin/carbohydrate ratio as well as correction factors
    • Adjusting insulin and dietary therapy during special situations (eg, exercise, stress, intermittent diseases)
  4. HbA1c ≥6.5 and ≤10.0% at screening.
  5. Fasting or stimulated C-peptide Concentration at Screening as follows:

    • C-peptide concentration ≥0.2 nmol/L if diagnosed within 3 years prior to screening.
    • C-peptide concentration ≥0.08 nmol/L if diagnosed between 3 and 15 years prior to screening.
  6. Documented history of at least 1 T1D1-related autoantibody.
  7. If treated with lipid-lowering therapy, the dose must be stable for at least 30 days prior to screening.
  8. Men and women of childbearing potential must use adequate birth control measures for the duration of the trial and at least 90 days after discontinuing study treatment.
  9. Women who are not pregnant or lactating.

Exclusion Criteria:

  1. Diagnosis of MODY, T2D or any other subtype of diabetes mellitus other than T1D.
  2. Have had recurrence (≥2 episodes) of severe hypoglycemia
  3. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.
  4. Use of diabetes medications except insulin within 2 months prior to screening.
  5. Any significant cardiovascular disease or QTcF prolongation within the last 6 months prior to screening.
  6. Participants with fasting triglyceride ≥500 mg/dL.
  7. Have an eGFR <60 mL/min/1.73 m2 by the CKDEPI Creatinine Equation at screening.
  8. Impaired liver function, defined as screening AST or ALT >1.5 × ULN, Total bilirubin >1.5 × ULN with the exception of Gilbert's Syndrome.
  9. History of acute or chronic pancreatitis, complete pancreatectomy or pancreas transplants.
  10. Serum lipase and/or amylase above 1.5 x ULN.
  11. Known positive test for HIV, HBV surface antigen and COVID-19.
  12. Diagnosis of, or treatment for, any cancer within the last 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy.
  13. Active (symptomatic) celiac disease.
  14. History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs.
  15. History of cirrhosis.
  16. Currently participating in a formal weight loss program and/or are currently using any drugs for weight management within 2 months of screening.
  17. Use of Proton pump inhibitors (PPIs) is prohibited.
  18. Treatment with a moderate or strong CYP3A4 inhibitor, inducer, or substrate within a week prior to dosing on Day 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06152042


Locations
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Sponsors and Collaborators
Biomea Fusion Inc.
Investigators
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Study Director: Juan Pablo Frias, MD Biomea Fusion Inc.
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Responsible Party: Biomea Fusion Inc.
ClinicalTrials.gov Identifier: NCT06152042    
Other Study ID Numbers: COVALENT-112
First Posted: November 30, 2023    Key Record Dates
Last Update Posted: June 18, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases