NCT06577935

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Angitia Biopharmaceuticals · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	AGA2118	Subcutaneous injection
OTHER	Placebo	Subcutaneous injection

Timeline

• Start date: 2024-10-31
• Primary completion: 2026-12-01
• Completion: 2028-03-01
• First posted: 2024-08-29
• Last updated: 2026-02-10

Locations

23 sites across 4 countries: United States, Argentina, Poland, Ukraine

Regulatory

• FDA-regulated drug study