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Clinical Trial Details

Trial ID: L2708
Source ID: NCT05731544
Associated Drug: Bmf-219
Title: Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: BMF-219
Outcome Measures: Primary: Safety Assessments, Assessed by treatment emergent adverse events. (TEAEs), drug discontinuation due to TEAEs, serious adverse events, clinically significant laboratory, vital, and ECG evaluations., 52 weeks|Pharmacokinetics Assessments, Assessed by effect of fed conditions on serial and sparse pharmacokinetic data., 12 weeks|Change in HbA1c, Assess the change in HbA1c from baseline to week 26., 26 weeks | Secondary: To assess the effect on HbA1c, Proportion of subjects achieving an HbA1c \< 7% at Week 26., 26 Weeks | Other: Exploratory: To determine the effects of BMF-219 on glycemic parameters in subjects with T2D., Assess changes in plasma glucose, c-peptide, and insulin at different timepoints by both fasted and in response to OGTT., Week 26|Exploratory: To determine the impact of multiple ascending doses of BMF-219 on beta-cell function in subjects with T2D., Descriptive summaries of homeostatic model assessment beta-cell function %beta and insulin resistance (HOMA-B and HOMA- IR)., Week 26
Sponsor/Collaborators: Sponsor: Biomea Fusion Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 414
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-17
Completion Date: 2025-05
Results First Posted:
Last Update Posted: 2025-02-14
Locations: Hope Clinical Research, Canoga Park, California, 91303, United States|Ark Clinical Research, LLC, Fountain Valley, California, 92708, United States|Velocity Clinical Research, Huntington Park, California, 90255, United States|Velocity Clinical Research, La Mesa, California, 91942, United States|Ark Clinical Research, Long Beach, California, 90815, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Metro Clinical Trials, San Bernardino, California, 92404, United States|CMR of Greater New Haven, LLC, Hamden, Connecticut, 06517, United States|Southwest General Healthcare Center, Fort Myers, Florida, 33907, United States|G+C Research Group, Hialeah, Florida, 33010, United States|Sunbright Health Research Centers, Homestead, Florida, 33032, United States|Diabetes Care Center, Hudson, Florida, 24667, United States|Panax Clinical Research, Miami Lakes, Florida, 33014, United States|Avantis Clinical Research, Miami, Florida, 33155, United States|Century Research LLC, Miami, Florida, 33173, United States|Entrust Clinical Research, Miami, Florida, 33176, United States|Omega Research Orlando, Orlando, Florida, 32808, United States|David Kavtaradze MD, Inc, Cordele, Georgia, 31015, United States|Privia Medical Group, Savannah, Georgia, 31406, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|IMA Clinical Research St. Louis, Saint Louis, Missouri, 63117, United States|Santa Rosa Medical Centers of Nevada, Las Vegas, Nevada, 89119, United States|Omera Health, Brooklyn, New York, 11220, United States|IMA Clinical Research Manhattan, New York, New York, 10036, United States|Carolina Research Center, Shelby, North Carolina, 28150, United States|Wake Forest Health Network, LLC, Medical Plaza, Winston-Salem, North Carolina, 27104, United States|Diabetes and Endocrinology Associates of Stark County, Canton, Ohio, 44718, United States|Medical Care, LLC, Elizabethton, Tennessee, 37643, United States|IMA Clinical Research, Austin, Texas, 78745, United States|Velocity Clinical Research, Dallas, Texas, 75230, United States|Zenos Clinical Research, Dallas, Texas, 75230, United States|Synergy Groups Medical LLC, Houston, Texas, 77036, United States|Synergy Group Medical, Houston, Texas, 77061, United States|Synergy Group Medical, Missouri City, Texas, 77459, United States|Clinical Trials of Texas, LLC, San Antonio, Texas, 78229, United States|Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States|Simcare Medical Research, Sugar Land, Texas, 77478, United States|Velocity Clinical Research, Waco, Texas, 76710, United States|Velocity Clinical Research, Jordan, Utah, 84088, United States|Manassas Clinical Research, Manassas, Virginia, 20110, United States|BC Diabetes, Vancouver, British Columbia, V5Y 3W2, Canada|Centricity Research Brampton Endocrinology, Brampton, Ontario, L6S 0C6, Canada|Centricity Research LMC, Toronto, Ontario, M4G 3E8, Canada|BioPharma Services Inc., Toronto, M9L 3A2, Canada
URL: https://clinicaltrials.gov/show/NCT05731544

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress