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

Phase 2

Recruiting

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: AGA2118; Other: Placebo

• 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.

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Study Start: 2024-10-31
• Status Verified: 2024-12
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

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.

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 (25)

Centro Médico Arsema; 🇦🇷 Buenos Aires, Argentina

Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada; 🇦🇷 Buenos Aires, Argentina

Consultorio de Investigacion Clinica EMO SRL; 🇦🇷 Buenos Aires, Argentina

IDIM; 🇦🇷 Buenos Aires, Argentina

Investigaciones Reumatologicas y Osteologicas SRL; 🇦🇷 Buenos Aires, Argentina

Stat Research; 🇦🇷 Buenos Aires, Argentina

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

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