A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
- Registration Number
- NCT06577935
- Lead Sponsor
- Angitia Biopharmaceuticals
- Brief 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.
- Detailed Description
This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or femoral neck and no prior history of fragility fractures.
This study includes a 12 month blinded treatment phase where participants will be randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo. At Month 12, participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen, receive a new dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12 to 24.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 350
- 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.
- History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.
- Vitamin D deficiency.
- Known intolerance to calcium or vitamin D supplements.
- Untreated hyper- or hypothyroidism.
- Current hyper- or hypoparathyroidism.
- Elevated transaminases.
- Significantly impaired renal function.
- Current hypo- or hypercalcemia.
- Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.
- Malignancy within the last 5 years.
- Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.
- Myocardial infarction or stroke within the past 12 months.
- Use of agents affecting bone metabolism.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGA2118 Dose Regimen 2 AGA2118 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. AGA2118 Dose Regimen 3 AGA2118 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. AGA2118 Dose Regimen 1 AGA2118 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. AGA2118 Dose Regimen 5 AGA2118 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 Regimen Placebo 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. AGA2118 Dose Regimen 4 AGA2118 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. AGA2118 Dose Regimen 6 AGA2118 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.
- Primary Outcome Measures
Name Time Method Percent change from Baseline to Month 12 in lumbar spine bone mineral density 12 months 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
- Secondary Outcome Measures
Name Time Method Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density 3 and 6 months 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
Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density 12 months 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
Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1 1, 3, 6, 9, and 12 months To evaluate the effect of treatment with AGA2118 versus placebo at different time points on percent change from Baseline in P1NP and CTX-1
Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12 12 months To evaluate the incidence of new clinical fractures (vertebral and nonvertebral) from Baseline to Month 12
Trial Locations
- Locations (19)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Center for Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
Klein & Associates, M.D., P.A.
🇺🇸Cumberland, Maryland, United States
Montana Medical Research, Inc
🇺🇸Missoula, Montana, United States
NM Clinical Research & Osteoporosis Center, Inc.
🇺🇸Albuquerque, New Mexico, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Puget Sound Osteoporosis Center
🇺🇸Burien, Washington, United States
Centro Integral De reumatologia del Caribe - CIRCARIBE SAS
🇨🇴Barranquilla, Colombia
Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.
🇨🇴Barranquilla, Colombia
Blue Care Salud SAS
🇨🇴Bogota, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas E.U. - CIREEM E.U
🇨🇴Bogota, Colombia
Solano & Terront Servicios Médicos SAS - Unidad Integral de Endocrinología - UNIENDO
🇨🇴Bogota, Colombia
Futuremeds Gdynia
🇵🇱Gdynia, Poland
Krakowskie Centrum Medyczne
🇵🇱Kraków, Poland
Futuremeds Warszawa Centrum
🇵🇱Warszawa, Poland
Futuremeds Targowek
🇵🇱Warszawa, Poland
Futuremeds Wroclaw
🇵🇱Wrocław, Poland
Futuremeds Lodz
🇵🇱Łódź, Poland