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Recruiting Phase 2

Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)

NCT07062588 · tracked via the Priya Life Science France tracker
Sponsor
Angitia Incorporated Limited
Phase
Phase 2
Started
2025-12-12
Last updated
2026-10-14

Condition(s) studied

Osteogenesis Imperfecta (OI)

Investigational drug(s) / intervention(s)

AGA2115 →Placebo

AGA2115: Subcutaneous injection

Placebo: Subcutaneous injection

Study summary

This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol * BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck Exclusion Criteria: * Vitamin D deficiency * Concomitant uncontrolled diseases or conditions that could affect bone metabolism such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, abnormal thyroid function or thyroid disease, or other endocrine disorders * Current hyper- or hypocalcemia * History of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures * Treatment with bisphosphonates within the past 6 months * Treatment with teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months * Treatment with denosumab (or denosumab biosimilars) within the past 2 years * Treatment with anti-sclerostin antibody medications (romosozumab, setrusumab, blosozumab) at any time * History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant) within the past 12 months * Malignancy within the last 5 years * Pregnant or breastfeeding women, or women planning to become pregnant during the study * Participation in any clinical study within the past 12 months during which the participant was administered any IP (participant must also agree not to enroll in any other clinical study concurrently in which IP is administered)

Primary outcome measure(s)

  • Percent change from Baseline at Month 12 in lumbar spine BMD — 12 months

Trial sites (26)

FacilityCityRegionStatus
Phoenix Children's Phoenix Arizona Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
Nemours/Alfred I. duPont Hospital for Children Wilmington Delaware Recruiting
Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology Indianapolis Indiana Recruiting
Washington University School of Medicine in St. Louis St Louis Missouri Not Yet Recruiting
New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC) Albuquerque New Mexico Recruiting
The Ohio State University Wexner Medical Center (OSUWMC) Columbus Ohio Not Yet Recruiting
Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic Portland Oregon Recruiting
Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic Nashville Tennessee Not Yet Recruiting
Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro Buenos Aires Argentina Recruiting
Monash University-Monash Medical Centre (MMC) Melbourne Australia Recruiting
Royal Melbourne Hospital Parkville Australia Recruiting
Royal North Shore Hospital (RNSH) Saint Leonards Australia Recruiting
Adults Westmead Hospital Westmead Australia Not Yet Recruiting
University Health Network - Toronto General Hospital - Osteoporosis Clinic Toronto Ontario Recruiting
Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade Aarhus Denmark Not Yet Recruiting
Odense Universitetshospital Odense Denmark Not Yet Recruiting
Hopital Edouard Herriot Lyon France Not Yet Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere Paris France Not Yet Recruiting
Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit Leiden Netherlands Not Yet Recruiting
Erasmus MC Rotterdam Netherlands Not Yet Recruiting
Isala ziekenhuizen Zwolle Netherlands Not Yet Recruiting
Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital Cambridge United Kingdom Not Yet Recruiting
Lothian Health Board, Western General Hospital Edinburgh United Kingdom Recruiting
Royal National Orthopaedic Hospital NHS Trust London United Kingdom Recruiting
Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom Not Yet Recruiting
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 NCT07062588 on ClinicalTrials.gov ↗ ← All trials in France