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

Last updated: February 6, 2026
Sponsor: Angitia Biopharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Post-menopausal Osteopenia

Osteoporosis

Treatment

AGA2118

Placebo

Clinical Study ID

NCT06577935
ACT23-001
  • Ages 55-80
  • Female

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 Criteria

Inclusion

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

Exclusion Criteria:

  • History of vertebral fracture, or fragility fracture of the wrist, humerus, proximalfemur, 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 increasesrisk of cancer.

  • Myocardial infarction or stroke within the past 12 months.

  • Use of agents affecting bone metabolism.

Study Design

Total Participants: 379
Treatment Group(s): 2
Primary Treatment: AGA2118
Phase: 2
Study Start date:
October 31, 2024
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

  • Centro Médico Arsema

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • Consultorio de Investigacion Clinica EMO SRL

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • IDIM

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • Investigaciones Reumatologicas y Osteologicas SRL

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • Mautalen - Salud e Investigacion (Expertia S.A.)

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • Stat Research

    Buenos Aires 3435910, Argentina
    Argentina

    Site Not Available

  • Instituto Médico Strusberg

    Córdoba 3860259, Argentina
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucumán 3836873, Argentina
    Argentina

    Site Not Available

  • Centro Médico Arsema

    Buenos Aires,
    Argentina

    Site Not Available

  • Centro Médico Dra Laura Maffei e Investigación Cliínica Aplicada

    Buenos Aires,
    Argentina

    Site Not Available

  • Consultorio de Investigacion Clinica EMO SRL

    Buenos Aires,
    Argentina

    Site Not Available

  • IDIM

    Buenos Aires,
    Argentina

    Site Not Available

  • Investigaciones Reumatologicas y Osteologicas SRL

    Buenos Aires,
    Argentina

    Site Not Available

  • Stat Research

    Buenos Aires,
    Argentina

    Site Not Available

  • CER Instituto Medico

    Buenos Aires 3435910,
    Argentina

    Site Not Available

  • CIDIIM

    Córdoba 3860259,
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Mar del Plata CIM

    Mar del Plata 3430863,
    Argentina

    Site Not Available

  • UMHAT Plovdiv AD

    Plovdiv,
    Bulgaria

    Site Not Available

  • Diagnostic-consultative center Ascendent EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • Centro Integral De reumatologia del Caribe - CIRCARIBE SAS

    Barranquilla 3689147, Colombia 080002
    Colombia

    Site Not Available

  • Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.

    Barranquilla 3689147, Colombia
    Colombia

    Site Not Available

  • Blue Care Salud SAS

    Bogotá 3688689, Colombia
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialidades Medicas E.U. - CIREEM E.U

    Bogotá 3688689, Colombia
    Colombia

    Site Not Available

  • Solano & Terront Servicios Médicos SAS - Unidad Integral de Endocrinología - UNIENDO

    Bogotá 3688689, Colombia
    Colombia

    Site Not Available

  • Centro Integral De reumatologia del Caribe - CIRCARIBE SAS

    Barranquilla, 080002
    Colombia

    Site Not Available

  • Centro de Investigación Médico Asistencial S.A.S. - CIMEDICAL S.A.S.

    Barranquilla,
    Colombia

    Site Not Available

  • Blue Care Salud SAS

    Bogota,
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialidades Medicas E.U. - CIREEM E.U

    Bogota,
    Colombia

    Site Not Available

  • Solano & Terront Servicios Médicos SAS - Unidad Integral de Endocrinología - UNIENDO

    Bogota,
    Colombia

    Site Not Available

  • Aarhus University Hospital

    Aarhus N,
    Denmark

    Site Not Available

  • Aalborg University Hospital

    Gistrup,
    Denmark

    Site Not Available

  • Center for Clinical and Basic Research AS

    Tallinn,
    Estonia

    Site Not Available

  • East Tallinn Central Hospital

    Tallinn,
    Estonia

    Site Not Available

  • MediTrials 505-855-5505

    Tartu,
    Estonia

    Site Not Available

  • Zdrowie Osteo-Medic sc A i L Racewicz

    Białystok, 15-351
    Poland

    Site Not Available

  • Futuremeds Gdynia

    Gdynia, 81-384
    Poland

    Site Not Available

  • Futuremeds Gdynia

    Gdynia 3099424, 81-384
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne

    Krakow 3094802, 31-501
    Poland

    Site Not Available

  • Krakowskie Centrum Medyczne

    Kraków, 31-501
    Poland

    Site Not Available

  • Futuremeds Lodz

    Lodz 3093133, 91-363
    Poland

    Site Not Available

  • Velocity Skierniewice

    Skierniewice, 96-100
    Poland

    Site Not Available

  • PIM MSWiA

    Warsaw, 02-507
    Poland

    Site Not Available

  • Futuremeds Targowek

    Warsaw 756135, 03-291
    Poland

    Site Not Available

  • Futuremeds Warszawa Centrum

    Warsaw 756135, 00-215
    Poland

    Site Not Available

  • Futuremeds Targowek

    Warszawa, 03-291
    Poland

    Site Not Available

  • Futuremeds Warszawa Centrum

    Warszawa, 00-215
    Poland

    Site Not Available

  • Futuremeds Wroclaw

    Wroclaw 3081368, 53-673
    Poland

    Site Not Available

  • Futuremeds Wroclaw

    Wrocław, 53-673
    Poland

    Site Not Available

  • ETG Zamosc

    Zamość, 22-400
    Poland

    Site Not Available

  • Futuremeds Lodz

    Łódź, 91-363
    Poland

    Site Not Available

  • Lubelskie Centrum Diagnostyczne

    Świdnik, 21-040
    Poland

    Site Not Available

  • CE "Hospital #1" of Zhytomyr City Council

    Kyiv 703448, Ukraine
    Ukraine

    Site Not Available

  • Medical Center Universal Clinic "Oberig" of "Kapytal" LCC

    Kyiv 703448, Ukraine
    Ukraine

    Site Not Available

  • PSSE Medical Centre Pulse

    Vinnytsia 689558, Ukraine
    Ukraine

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Del Sol Research Management, LLC

    Tucson 5318313, Arizona 5551752 85715
    United States

    Site Not Available

  • Center for Advanced Research & Education

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Center for Advanced Research & Education

    Gainesville 4196586, Georgia 4197000 30501
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Klein & Associates, M.D., P.A.

    Cumberland 4352681, Maryland 4361885 21502
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Montana Medical Research, Inc

    Missoula, Montana 59808
    United States

    Site Not Available

  • Montana Medical Research, Inc

    Missoula 5666639, Montana 5667009 59808
    United States

    Site Not Available

  • NM Clinical Research & Osteoporosis Center, Inc.

    Albuquerque, New Mexico 87160
    United States

    Site Not Available

  • NM Clinical Research & Osteoporosis Center, Inc.

    Albuquerque 5454711, New Mexico 5481136 87160
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Site Not Available

  • Puget Sound Osteoporosis Center

    Burien, Washington 98166
    United States

    Site Not Available

  • Puget Sound Osteoporosis Center

    Burien 5788516, Washington 5815135 98166
    United States

    Site Not Available

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