A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 55
Maximum Age: 80
Healthy Volunteers: f
View:
• Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80.
• BMD T-score of ≤ -2.5 to \> -3.5 at the lumbar spine, total hip, or femoral neck.
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Del Sol Research Management, LLC
RECRUITING
Tucson
Georgia
Center for Advanced Research & Education
RECRUITING
Gainesville
Maryland
Klein & Associates, M.D., P.A.
RECRUITING
Cumberland
Montana
Montana Medical Research, Inc
RECRUITING
Missoula
New Mexico
NM Clinical Research & Osteoporosis Center, Inc.
RECRUITING
Albuquerque
Pennsylvania
Altoona Center for Clinical Research
RECRUITING
Duncansville
Washington
Puget Sound Osteoporosis Center
RECRUITING
Burien
Other Locations
Argentina
Centro Médico Arsema
NOT_YET_RECRUITING
Buenos Aires
Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada
NOT_YET_RECRUITING
Buenos Aires
Consultorio de Investigacion Clinica EMO SRL
NOT_YET_RECRUITING
Buenos Aires
IDIM
NOT_YET_RECRUITING
Buenos Aires
Investigaciones Reumatologicas y Osteologicas SRL
NOT_YET_RECRUITING
Buenos Aires
Stat Research
NOT_YET_RECRUITING
Buenos Aires
Colombia
Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.
NOT_YET_RECRUITING
Barranquilla
Centro Integral De reumatologia del Caribe - CIRCARIBE SAS
NOT_YET_RECRUITING
Barranquilla
Blue Care Salud SAS
NOT_YET_RECRUITING
Bogotá
Centro de Investigacion en Reumatologia y Especialidades Medicas E.U. - CIREEM E.U
NOT_YET_RECRUITING
Bogotá
Solano & Terront Servicios Médicos SAS - Unidad Integral de Endocrinología - UNIENDO
NOT_YET_RECRUITING
Bogotá
Poland
Futuremeds Gdynia
NOT_YET_RECRUITING
Gdynia
Krakowskie Centrum Medyczne
NOT_YET_RECRUITING
Krakow
Futuremeds Lodz
NOT_YET_RECRUITING
Lodz
Futuremeds Targowek
NOT_YET_RECRUITING
Warsaw
Futuremeds Warszawa Centrum
NOT_YET_RECRUITING
Warsaw
Futuremeds Wroclaw
NOT_YET_RECRUITING
Wroclaw
Contact Information
Primary
Deborah Lium
clinicaltrials@angitiabio.com
818-862-2068
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2027-08
Participants
Target number of participants: 350
Treatments
Experimental: AGA2118 Dose Regimen 1
AGA2118 selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Experimental: AGA2118 Dose Regimen 2
AGA2118 selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Experimental: AGA2118 Dose Regimen 3
AGA2118 selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Experimental: AGA2118 Dose Regimen 4
AGA2118 selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Experimental: AGA2118 Dose Regimen 5
AGA2118 selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Experimental: AGA2118 Dose Regimen 6
AGA2118 selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Placebo_comparator: Placebo Regimen
Placebo selected dose~Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
Related Therapeutic Areas
Sponsors
Leads: Angitia Biopharmaceuticals