Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants (NCT07223216) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants
United States80 participantsStarted 2025-10-23
Plain-language summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-650 in Otherwise Healthy Overweight or Obese Participants.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
✓. Must be willing and able to comply with all study requirements
✓. Healthy males or non-pregnant, non-lactating healthy females with obesity or overweight.
✓. For Part 1 (SAD cohorts), BMI of 25.0 to 40.0 kg/m2 as measured at screening, with no chronic health conditions.
✓. For Part 2 (MAD cohorts), BMI of 30.0 to 45.0 kg/m2, as measured at screening with no chronic health conditions.
✓. Have a stable body weight (less than or equal to 5% body weight gain or loss) for 3 months prior to screening.
✓. HbA1c ≤ 6.5%
Exclusion criteria
✕. Known self or family history (first-degree relative) of medullary thyroid cancer and/or multiple endocrine neoplasia Type 2 (MEN2).
✕. History of stomach or intestinal surgery or resection and/or gastroparesis (except that appendectomy and/or hernia repair will be allowed).
✕. Significant history of or currently have major depressive disorder or psychiatric disorder or suicidal ideation within the last 2 years.
✕. Severe uncontrolled treated or untreated hypertension (systolic blood pressure \[BP\] \>150 mmHg or diastolic BP \>90 mmHg).