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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Osteogenesis Imperfecta (OI)

In brief

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

Key facts

Study ID

NCT07062588

Run by

Angitia Incorporated Limited

People needed

80

Starts

2025-12-12

Expected to finish

2029-02-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro — Buenos Aires, Argentina (enrolling)
• Monash University-Monash Medical Centre (MMC) — Melbourne, Australia (enrolling)
• Royal Melbourne Hospital — Parkville, Australia (enrolling)
• Royal North Shore Hospital (RNSH) — Saint Leonards, Australia (enrolling)
• Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology — Indianapolis, Indiana, United States (enrolling)
• University Health Network - Toronto General Hospital - Osteoporosis Clinic — Toronto, Ontario, Canada (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC) — Albuquerque, New Mexico, United States (enrolling)
• Phoenix Children's — Phoenix, Arizona, United States (enrolling)
• Hopital Edouard Herriot — Lyon, France
• Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere — Paris, France
• Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit — Leiden, Netherlands
• Erasmus MC — Rotterdam, Netherlands
• Isala ziekenhuizen — Zwolle, Netherlands
• Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital — Cambridge, United Kingdom
• Lothian Health Board, Western General Hospital — Edinburgh, United Kingdom
• Royal National Orthopaedic Hospital NHS Trust — London, United Kingdom
• Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• The Ohio State University Wexner Medical Center (OSUWMC) — Columbus, Ohio, United States
• Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic — Portland, Oregon, United States
• Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic — Nashville, Tennessee, United States
• Adults Westmead Hospital — Westmead, Australia
• Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade — Aarhus, Denmark

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.