A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS
NCT Number: NCT06577935
Acronym: ARTEMIS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Postmenopausal Osteoporosis
Interventions: DRUG: AGA2118|OTHER: Placebo
Sponsor: Angitia Incorporated Limited
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-08
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States|Del Sol Research Management, LLC, Tucson, Arizona, 85715, United States|Center for Advanced Research & Education, Gainesville, Georgia, 30501, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Montana Medical Research, Inc, Missoula, Montana, 59808, United States|NM Clinical Research & Osteoporosis Center, Inc., Albuquerque, New Mexico, 87160, United States|Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States|Puget Sound Osteoporosis Center, Burien, Washington, 98166, United States|UMHAT Plovdiv AD, Plovdiv, Bulgaria|Diagnostic-consultative center Ascendent EOOD, Sofia, Bulgaria|Aarhus University Hospital, Aarhus N, Denmark|Aalborg University Hospital, Gistrup, Denmark|Center for Clinical and Basic Research AS, Tallinn, Estonia|East Tallinn Central Hospital, Tallinn, Estonia|MediTrials 505-855-5505, Tartu, Estonia|Zdrowie Osteo-Medic sc A i L Racewicz, Białystok, 15-351, Poland|Futuremeds Gdynia, Gdynia, 81-384, Poland|Krakowskie Centrum Medyczne, Kraków, 31-501, Poland|Velocity Skierniewice, Skierniewice, 96-100, Poland|PIM MSWiA, Warsaw, 02-507, Poland|Futuremeds Warszawa Centrum, Warszawa, 00-215, Poland|Futuremeds Targowek, Warszawa, 03-291, Poland|Futuremeds Wroclaw, Wrocław, 53-673, Poland|ETG Zamosc, Zamość, 22-400, Poland|Futuremeds Lodz, Łódź, 91-363, Poland|Lubelskie Centrum Diagnostyczne, Świdnik, 21-040, Poland

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.

Primary Outcome Measures: Percent change from Baseline to Month 12 in lumbar spine bone mineral density, To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in bone mineral density at the lumbar spine in postmenopausal women with low bone mineral density, 12 months
Secondary Outcome Measures: Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density, To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius, 3 and 6 months|Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density, To evaluate the effect of treatment with AGA2118 versus placebo at different timepoints on percent change from Baseline in bone mineral density at the lumbar spine, total hip, femoral neck, and one-third distal radius, 12 months|Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1, To evaluate the effect of treatment with AGA2118 versus placebo at different time points on percent change from Baseline in P1NP and CTX-1, 1, 3, 6, 9, and 12 months|Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12, To evaluate the incidence of new clinical fractures (vertebral and nonvertebral) from Baseline to Month 12, 12 months
Other Outcome Measures: Assessment of TEAEs (collection and documentation of all adverse events occurring during the study), Baseline to 24 months|Number of participants who develop anti-AGA2118 antibodies, To assess the formation of anti-AGA2118 antibodies, Baseline to 24 months|Evaluation of AGA2118 observed serum concentration levels for the AGA2118 treatment groups at Week 1 post-treatment and trough levels prior to dosing, To characterize the pharmacokinetic parameters of the different AGA2118 doses, Baseline to 24 months