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

NCT06152042 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: COVALENT-112
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 11

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• To assess the effect on endogenous insulin secretion

  Mean change from baseline in stimulated C-peptide AUC.

  26 Weeks

Secondary Outcomes (7)

• To assess the effect on endogenous insulin secretion

  26 Weeks

• To assess the effect on additional glycemic parameters

  26 Weeks of treatment

• To assess the effect on additional glycemic parameters

  26 Weeks

• To assess hypoglycemia events

  26 weeks

• To assess the effect on insulin doses

  26 Weeks

Study Arms (3)

Part 1

EXPERIMENTAL

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

Part 2

EXPERIMENTAL

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

Placebo Comparator

PLACEBO COMPARATOR

Part 2 Study Double Blind Arm C matching placebo for 12 weeks.

Drug: BMF-219

Interventions

BMF-219 DRUG

BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Part 1; Part 2; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age ≥18 and ≤70 years.
• 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.
• 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)
• HbA1c ≥6.5 and ≤10.0% at screening.
• 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.
• Documented history of at least 1 T1D1-related autoantibody.
• If treated with lipid-lowering therapy, the dose must be stable for at least 30 days prior to screening.

You may not qualify if:

• Diagnosis of MODY, T2D or any other subtype of diabetes mellitus other than T1D.
• Have had recurrence (≥2 episodes) of severe hypoglycemia
• Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1.
• Use of diabetes medications except insulin within 2 months prior to screening.
• Any significant cardiovascular disease or QTcF prolongation within the last 6 months prior to screening.
• Participants with fasting triglyceride ≥500 mg/dL.
• Have an eGFR \<60 mL/min/1.73 m2 by the CKDEPI Creatinine Equation at screening.
• Impaired liver function, defined as screening AST or ALT \>1.5 × ULN, Total bilirubin \>1.5 × ULN with the exception of Gilbert's Syndrome.
• History of acute or chronic pancreatitis, complete pancreatectomy or pancreas transplants.
• Serum lipase and/or amylase above 1.5 x ULN.
• Known positive test for HIV, HBV surface antigen and COVID-19.
• 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.
• Active (symptomatic) celiac disease.
• History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs.
• History of cirrhosis.

Sponsors & Collaborators

• Biomea Fusion Inc.: lead

Study Sites (11)

Oceanic Research Group

North Miami Beach, Florida, 33169, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28577, United States

Location

Alliance for Multispecialty Research, LLC.

Norman, Oklahoma, 73069, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Texas Diabetes & Endocrinology

Round Rock, Texas, 78681, United States

Location

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Dr. T.G Elliott Inc. dba BC Diabetes

Vancouver, British Columbia, Canada

Location

Centricity Research

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Juan Pablo Frias, MD

  Biomea Fusion Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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%).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 30, 2023
• Study Start: December 28, 2023
• Primary Completion: May 20, 2025
• Study Completion: July 18, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (9)