Clinical Trial Tests New Technique to Stimulate Beta Cells
By April Hopcroft
Join a study investigating a new oral medication, BMF-219, that could stimulate beta cell growth in people with type 2 diabetes. A study in type 1 diabetes is on the horizon, following FDA clearance earlier this month.
Clinical Trials Identifier: NCT05731544
Trial Name: Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (COVALENT-111)
Diabetes Type: Adults with type 2 diabetes
Trial Sponsor: Biomea Fusion Inc.
What is the trial researching?
This trial is studying the safety, tolerability, and mechanism of action of the investigational medication BMF-219 in adults with type 2 diabetes, as well as healthy volunteers.
BMF-219 is a menin inhibitor. Menin is a protein that acts as a tumor suppressor in the endocrine organs, which prevents beta cells from growing too fast in healthy people. Based on menin’s role in barring excess growth of beta cells, researchers hypothesize that blocking menin may lead to beta cell growth in people with diabetes.
The study will enroll 188 participants and will last roughly 14-18 months.
Why is this important?
Loss of beta cell mass is a key cause of both types of diabetes. In type 1 diabetes, this is due to autoimmune destruction and in type 2 diabetes this is caused by metabolic dysfunction. According to Biomea Fusion, menin acts as a “brake” on beta cell growth. This suggests that inhibiting menin could stimulate regeneration of normal, healthy beta cells.
Indeed, BMF-219 demonstrated the potential to restore beta cell mass in early, preclinical studies. These studies also found that BMF-219 significantly lowered blood glucose compared to placebo. In addition to promising reductions on blood glucose, BMF-219 led to dramatic improvements in time in range in two case reports presented at ADA 2023.
If approved, BMF-219 would be the first disease-modifying therapy for type 2 diabetes, meaning that the medication delays or slows progression of the disease. In other words, this treatment addresses the underlying cause of disease, rather than simply treating the symptoms.
Are you interested?
You may be eligible for the study in type 2 diabetes if you:
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Are between 18-65 years old.
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Have been diagnosed with type 2 diabetes within the last 15 years.
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Manage your diabetes with lifestyle changes with or without at most three diabetes medications (metformin, SGLT-2 inhibitors, GLP-1 receptor agonists, or DPP-4 inhibitors).
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Have an A1C of 7% or greater and 10% or less.
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Have a BMI of 25 or greater and 40 or less.
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Are not pregnant or breastfeeding.
People with type 1 diabetes, recurrent severe hypoglycemia within the past six months, or a cardiovascular event in the past six months are not eligible for this study. See a full list of inclusion/exclusion criteria here.
This study is currently recruiting in several locations across the U.S. and Canada. To learn more about this trial, contact the study team at [email protected] or call (+)1-844-245-0490.
An upcoming study will investigate BMF-219 in type 1 diabetes
In October 2023, Biomea Fusion announced that the FDA approved a phase 2 trial of BMF-219 in type 1 diabetes. This study, COVALENT-112, will investigate the safety and efficacy of BMF-219 in restoring beta cell function in 150 adults with type 1 diabetes.
Participants will receive treatment with either BMF-219 or placebo for 12 weeks, followed by a 40-week “off-treatment” period, so the study will last about one year. Although this trial is not yet recruiting, it’s slated to begin soon.
Learn more about new treatments for diabetes here:
