A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.