Type 1 Diabetes MellitusPhase 2NCT06152042
Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus
A Phase 2 study testing BMF-219 in people with Type 1 Diabetes Mellitus, run by Biomea Fusion Inc. at 11 sites in 2 countries.
Trial summary
Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- BMF-219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 28 Dec 2023to 18 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
- 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.
- Women who are not pregnant or lactating.
Who cannot join
- 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.
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- 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.
- Currently participating in a formal weight loss program and/or are currently using any drugs for weight management within 2 months of screening.
- Use of Proton pump inhibitors (PPIs) is prohibited.
- Treatment with a moderate or strong CYP3A4 inhibitor, inducer, or substrate within a week prior to dosing on Day 1.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37411
Velocity Clinical Research
Dallas, Texas, 75230
Manassas Clinical Research Center
Manassas, Virginia, 20110
Lucas Research, Inc.
Morehead City, North Carolina, 28577
Alliance for Multispecialty Research, LLC.
Norman, Oklahoma, 73069
Oceanic Research Group
North Miami Beach, Florida, 33169
Texas Diabetes & Endocrinology
Round Rock, Texas, 78681
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Canada2 sites
Centricity Research
Toronto, Ontario
Dr. T.G Elliott Inc. dba BC Diabetes
Vancouver, British Columbia
About this study
Official title: Phase 2 Randomized, Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus
Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- BMF-219
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMF-219Drug
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: BMF-219 |
| Placebo Comparator | Placebo comparator | Part 2 Study Double Blind Arm C matching placebo for 12 weeks. Receives: Drug: BMF-219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect on endogenous insulin secretion
Mean change from baseline in stimulated C-peptide AUC.
Measured: 26 Weeks
Secondary outcomes (7)
To assess the effect on endogenous insulin secretion
Maximum stimulated C-peptide: the highest value at any time point during the 4-hour MMTT.
Measured: 26 Weeks
To assess the effect on additional glycemic parameters
Mean change from baseline in HbA1c.
Measured: 26 Weeks of treatment
To assess the effect on additional glycemic parameters
Mean change from baseline in FPG.
Measured: 26 Weeks
To assess hypoglycemia events
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.
Measured: 26 weeks
To assess the effect on insulin doses
Change from baseline in mean daily insulin dosing.
Measured: 26 Weeks
Rate of symptomatic hypoglycemic episodes
Evaluation and comparison of the number of symptomatic (both minor and severe) hypoglycemic episodes with BMF-219 vs placebo during the study.
Measured: 26 Weeks and during study duration
Incidence of adverse events
Evaluation and comparison of the number of adverse events with BMF-219 vs placebo during the study.
Measured: 26 Weeks and during study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start28 Dec 2023
- Primary completion20 May 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomea Fusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152042
- Sponsor's protocol ID
- COVALENT-112
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Double-blind Trial of BMF-219 Compared to Placebo in Participants With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06152042
- Acronym / sponsor ID
- COVALENT-112
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Biomea Fusion Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: BMF-219Part 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 |
| Part 2 | Experimental | Drug: BMF-219Part 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 |
| Placebo Comparator | Placebo comparator | Drug: BMF-219Part 2 Study Double Blind Arm C matching placebo for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males or females, age ≥18 and ≤70 years.
- Diagnosed with stage 3 T1D within the following timeframes:
- Treated with insulin only for at least 2 months prior to screening and proficient in the following in the opinion of the investigator:
- HbA1c ≥6.5 and ≤10.0% at screening.
- Fasting or stimulated C-peptide Concentration at Screening as follows:
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMF-219BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. | Drug | Part 1, Part 2, Placebo Comparator |
Primary outcome
To assess the effect on endogenous insulin secretion
Time frame: 26 Weeks
Mean change from baseline in stimulated C-peptide AUC.
7 secondary outcomes
To assess the effect on endogenous insulin secretion
Time frame: 26 Weeks
To assess the effect on additional glycemic parameters
Time frame: 26 Weeks of treatment
To assess the effect on additional glycemic parameters
Time frame: 26 Weeks
To assess hypoglycemia events
Time frame: 26 weeks
To assess the effect on insulin doses
Time frame: 26 Weeks
Rate of symptomatic hypoglycemic episodes
Time frame: 26 Weeks and during study duration
Incidence of adverse events
Time frame: 26 Weeks and during study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMF-219 in people with Type 1 Diabetes Mellitus, run by Biomea Fusion Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect on endogenous insulin secretion (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.