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Covalent Menin Inhibitor
BMF-219 for Type 2 Diabetes
Verified Trial
Phase 1 & 2
Recruiting
Research Sponsored by Biomea Fusion Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All subjects must be willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.
Diagnosed with T2DM within the last 7 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new pill called BMF-219 that targets a protein named menin. It includes healthy adults and those with Type 2 Diabetes to see if it helps control blood sugar levels.
Who is the study for?
Adults aged 18-65 with Type 2 Diabetes Mellitus (T2DM) and a BMI of 25-40 kg/m^2, or healthy adults within the same age range but with a BMI of 18-35 kg/m^2. Participants must not be pregnant, should use contraception if applicable, and have stable health as determined by medical history and tests. Treated T2DM subjects may be on up to three anti-diabetic medications.
What is being tested?
The trial is testing BMF-219, an oral covalent menin inhibitor. It's a randomized, double-blind study comparing the effects of BMF-219 against a placebo in both healthy adults and those with T2DM to assess safety, tolerability, how the body processes it (pharmacokinetics), and its effectiveness (pharmacodynamics).
What are the potential side effects?
While specific side effects for BMF-219 are not listed here, common side effects from similar diabetes medications can include low blood sugar levels (hypoglycemia), digestive issues like nausea or diarrhea, potential liver enzyme changes, fatigue or headache.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of fed conditions on PK and TEAEs following a single and multiple doses of BMF-219 in healthy subjects.
Treatment of emergent adverse events and observed in single and multiple ascending oral doses of BMF-219 in healthy subjects and subjects with T2DM.
Secondary study objectives
Pharmacokinetics of BMF-219 single and multiple ascending doses of BMF-219 in healthy subjects and subjects with T2DM.
To assess the effect of multiple ascending doses of BMF-219 on body composition in subjects with T2DM.
To determine the impact of multiple ascending doses of BMF-219 on beta-cell function in subjects with T2DM.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 (MAD Cohorts)Experimental Treatment1 Intervention
Phase 2 comprises of 1 cohort of 16 healthy adult subjects randomized at 3:1 (active and placebo) and 7 cohorts of T2DM adult subjects randomized at 5:1 (active and placebo) to obtain further safety and efficacy data to identify the potential optimal biological dose (OBD)/recommended Phase 2 dose (RP2D).
Group II: Phase 1 single dose, 3-period crossover, food effect substudy in 2 cohorts.Experimental Treatment1 Intervention
Each cohort comprises of 12 healthy adult subjects randomized at 1:1:1:1:1:1 in a 3-period crossover study with 6 treatment sequences.
Group III: Phase 1 (SAD Cohorts)Experimental Treatment1 Intervention
Phase 1 comprises of randomized healthy adult subjects in 4 cohorts. 10 subjects will be randomized at 7:3 (active and placebo) in sequential order in 4 dose escalating cohorts. Each cohort is composed of 2 sentinel subjects randomized at 1:1 (active and placebo), followed by 8 additional subjects randomized at 3:1 (active and placebo).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Type 2 Diabetes (T2DM) work through various mechanisms to control blood glucose levels. Metformin decreases hepatic glucose production and increases insulin sensitivity.
Sulfonylureas stimulate insulin secretion from pancreatic beta cells. DPP-4 inhibitors prolong the action of incretin hormones, which increase insulin release and decrease glucagon levels.
GLP-1 receptor agonists enhance glucose-dependent insulin secretion and slow gastric emptying. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion.
Insulin therapy directly supplements or replaces endogenous insulin. These mechanisms are crucial for T2DM patients as they address different aspects of the disease's pathophysiology, providing comprehensive glycemic control.
BMF-219, a covalent menin inhibitor, represents a novel approach by potentially targeting specific molecular pathways involved in T2DM, although its exact mechanism in this context requires further elucidation.
The Mystery of Diabetic Cardiomyopathy: From Early Concepts and Underlying Mechanisms to Novel Therapeutic Possibilities.Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.
The Mystery of Diabetic Cardiomyopathy: From Early Concepts and Underlying Mechanisms to Novel Therapeutic Possibilities.Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline.Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Biomea Fusion Inc.Lead Sponsor
4 Previous Clinical Trials
567 Total Patients Enrolled
Stephen Morris, MDStudy DirectorBiomea Fusion Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are taking metformin, you must have been taking at least 500mg per day consistently before the screening visit.You smoke more than 5 cigarettes a day and you are a healthy individual.If you're a healthy individual, you're taking medication that can't be stopped during the screening process.If you are a healthy person, you cannot be taking proton pump inhibitors.If you drink too many beverages containing methylxanthine, you cannot participate.You have a known or suspected allergy to the trial product or its ingredients.If you are a healthy person, you cannot have a history of severe allergies to multiple drugs.If you are a healthy person, you are not currently dieting or taking any weight management medications.You have type 2 diabetes and a personal or family history of multiple endocrine neoplasia type 1.If you have Type 2 Diabetes, you will be excluded from the study if you have a history of acute or chronic pancreatitis.You have type 2 diabetes, but you cannot participate if you have current infections of HIV, HCV, HBV, or COVID-19.If you have type 2 diabetes, you cannot be currently dieting or taking medication for weight loss.If you have type 2 diabetes, you cannot take proton pump inhibitors.You have type 2 diabetes and are allergic to the trial product, similar compounds, or ingredients.Your blood sugar level (measured by HbA1c) must be between 7.0% and 10%.If you have type 2 diabetes, you cannot have untreated or uncontrolled thyroid problems.You have type 2 diabetes and have severe nerve damage.If you have type 2 diabetes, you cannot have been diagnosed with or treated for any cancer in the past 2 years.If you have Type 2 Diabetes, you are excluded if you have a history of cirrhosis.You have type 2 diabetes and smoke more than 3 cigarettes per day.You are in good health based on your medical history, physical exam, ECG, and lab results.Your body mass index (BMI) falls between 18 and 35, which is considered a healthy weight range.You are between 18 and 65 years old, regardless of your gender.Female participants must not be pregnant or breastfeeding. If they can still have children, they must have a negative pregnancy test and use birth control during the study and for about 90 days after the study ends. They must also agree not to donate eggs or undergo fertility treatments during the study.You need to be able to understand and sign a paper that explains the study procedures and agree to follow them.If you are a man with a female partner who could become pregnant, you must agree to use at least two effective methods of birth control during the study and for 90 days after the study ends. You should also avoid donating sperm during this time. If you want to have children in the future, you should talk to your doctor about sperm donation and freezing before starting the treatment.You have been diagnosed with type 2 diabetes within the past 15 years.You manage your diabetes with diet and exercise or take up to three specific medications. You have been taking the same dose of these medications for at least two months before the screening.If you are a healthy person, you cannot participate in the study if you or a family member has a condition called multiple endocrine neoplasia Type 1.You have Type 2 Diabetes Mellitus or any other forms of diabetes, but not Type 1 Diabetes Mellitus. You should not have a history of diabetic ketoacidosis.You have type 2 diabetes and cannot have used any drugs except marijuana, or eaten any poppy seed-containing products 48 hours before the study.If you have type 2 diabetes, you cannot have taken corticosteroids by mouth or injection in the past 60 days before starting the study.If you have Type 2 Diabetes, you will be excluded if you have a history of severe drug allergies or multiple allergies.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 (SAD Cohorts)
- Group 2: Phase 1 single dose, 3-period crossover, food effect substudy in 2 cohorts.
- Group 3: Phase 2 (MAD Cohorts)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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