Join Trial Studying Beta Cell Stimulation for Type 1 Diabetes
A trial is recruiting adults with type 1 diabetes to investigate BMF-219, a new oral medication that stimulates beta cell growth. The drug has already shown promising results in type 2 diabetes, improving time in range and glycemic control.
Clinical Trials Identifier: NCT06152042
Trial Name: Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus (BF-MNN-112)
Diabetes Type: Adults with type 1 diabetes
Trial Sponsor: Biomea Fusion Inc.
What is the trial researching?
This trial is studying how the investigational medication BMF-219 affects insulin sensitivity, beta cell function, and glucose and lipid metabolism in adults with type 1 diabetes.
BMF-219 is a type of drug called a menin inhibitor. It works by blocking menin, a protein that prevents beta cells from growing too much. Researchers hypothesize that blocking menin may stimulate beta cell regeneration in people with diabetes. Researchers will measure how BMF-219 affects insulin secretion, as well as other measures of diabetes management like A1C, fasting plasma glucose, and the number of low blood sugar (hypoglycemia) events.
The FDA put a brief hold on BMF-219 research in June 2024 due to concerns about liver toxicity, but after a safety review, the trial is back on track. The study is expected to enroll approximately 190 participants and last about a year. Participants will receive BMF-219 or a placebo for 12 weeks, followed by a 40-week monitoring period with no treatment.
Why is this trial important?
Type 1 diabetes is defined as the loss of beta cells due to an attack by the body’s immune system. Researchers at Biomea Fusion are pursuing a novel approach to beta cell regeneration with BMF-219. Since menin acts as a “brake” on beta cell growth, researchers hypothesize that inhibiting menin could stimulate the regeneration of normal, healthy beta cells.
Initial results in type 2 diabetes have shown that BMF-219 has the potential to restore beta cell mass, lower blood glucose, and improve time in range.
If approved, BMF-219 would be the first disease-modifying therapy for treating type 1 diabetes. As an oral drug, it could potentially help reduce the burden of diabetes management, as it is much simpler and easier than insulin injections.
Currently, the only other disease-modifying therapy for type 1 diabetes is Tzield (teplizumab), a 14-day infusion approved to delay the onset of type 1 diabetes in eligible individuals at high risk for diabetes. Tzield is not for those who already have diabetes.
This study is important as other approaches to restore beta cells in type 1 diabetes, such as Vertex’s VX-880 stem cell therapy, are more invasive and require participants to take immunosuppressants for the rest of their lives.
Are you interested?
You may be eligible to participate if you have:
- Type 1 diabetes and are between 18-60 years of age
- An A1C between 6.5-10%
- A BMI of up to 40
- Used only insulin to manage your diabetes for at least the previous two months
The trial is currently recruiting in several locations throughout the U.S. and Canada. See a full list of inclusion/exclusion criteria here. People with type 2 diabetes are not eligible for this trial. Biomea Fusion is conducting a different trial for people with type 2.
For more information: Contact Dr. Christina Guzman at [email protected] or by phone at 1-844-245-0490.
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