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Clinical Trials in the USA / NCT06577935
Active, not recruiting Phase 2

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

NCT06577935 · tracked via the Priya Life Science USA tracker
Sponsor
Angitia Biopharmaceuticals
Phase
Phase 2
Started
2024-10-31
Last updated
2026-02-10

Condition(s) studied

Postmenopausal Osteoporosis

Investigational drug(s) / intervention(s)

AGA2118Placebo

AGA2118: Subcutaneous injection

Placebo: Subcutaneous injection

Study 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.

Eligibility

Sex
FEMALE
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Center for Advanced Research & Education Gainesville Georgia
NM Clinical Research & Osteoporosis Center, Inc. Albuquerque New Mexico
Altoona Center for Clinical Research Duncansville Pennsylvania
Puget Sound Osteoporosis Center Burien Washington
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
Mautalen - Salud e Investigacion (Expertia S.A.) Buenos Aires Argentina
Stat Research Buenos Aires Argentina
Instituto Médico Strusberg Córdoba Argentina
CIDIIM Córdoba Argentina
Centro de Investigaciones Medicas Mar del Plata CIM Mar del Plata Argentina
Futuremeds Gdynia Gdynia Poland
Krakowskie Centrum Medyczne Krakow Poland
Futuremeds Lodz Lodz Poland
Futuremeds Warszawa Centrum Warsaw Poland
Futuremeds Targowek Warsaw Poland
Futuremeds Wroclaw Wroclaw Poland
CE "Hospital #1" of Zhytomyr City Council Kyiv Ukraine
Medical Center Universal Clinic "Oberig" of "Kapytal" LCC Kyiv Ukraine
PSSE Medical Centre Pulse Vinnytsia Ukraine
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06577935 on ClinicalTrials.gov ↗ ← All trials in the USA