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

Last updated: May 15, 2025
Sponsor: Angitia Biopharmaceuticals
Overall Status: Active - 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: 350
Treatment Group(s): 2
Primary Treatment: AGA2118
Phase: 2
Study Start date:
October 31, 2024
Estimated Completion Date:
August 31, 2027

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

  • 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, 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

  • Krakowskie Centrum Medyczne

    Kraków, 31-501
    Poland

    Site Not Available

  • Velocity Skierniewice

    Skierniewice, 96-100
    Poland

    Site Not Available

  • PIM MSWiA

    Warsaw, 02-507
    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

    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

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Del Sol Research Management, LLC

    Tucson, Arizona 85715
    United States

    Active - Recruiting

  • Center for Advanced Research & Education

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Klein & Associates, M.D., P.A.

    Cumberland, Maryland 21502
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Montana Medical Research, Inc

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • NM Clinical Research & Osteoporosis Center, Inc.

    Albuquerque, New Mexico 87160
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Puget Sound Osteoporosis Center

    Burien, Washington 98166
    United States

    Active - Recruiting

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