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NCT07062588PHASE2Recruiting

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

Angitia Incorporated Limited

Start Date

12/12/2025

Completion Date

2/1/2029

Summary

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

Detailed Description

This Phase 2 dose-ranging study will evaluate the safety and efficacy of AGA2115 at a range of doses in adults with Type I, III, or IV osteogenesis imperfecta. The study will last 27 months with a 24-month treatment period and a 3-month follow-up period. During the first 12 months of the study, participants will be randomized 1:1:1:1 to receive either placebo or one of three dose levels of AGA2115 doses; treatment assignment will be double-blind. Months 12 to 24 will be open-label, and all participants will receive AGA2115. Participants will attend visits where safety and efficacy parameters will be evaluated.

Eligibility Criteria

Age Range: 18 years to 75 years

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)

Interventions

DRUG

AGA2115

OTHER

Placebo

Interested in This Trial?

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Conditions

Osteogenesis Imperfecta (OI)

Locations

Phoenix Children's

Phoenix, Arizona 85016

United States

Yale University School of Medicine

New Haven, Connecticut 06510

United States

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware 19803

United States

Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology

Indianapolis, Indiana 46202

United States

Washington University School of Medicine in St. Louis

St Louis, Missouri 63110

United States

New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)

Albuquerque, New Mexico 87160

United States

The Ohio State University Wexner Medical Center (OSUWMC)

Columbus, Ohio 43210

United States

Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic

Portland, Oregon 97239

United States

Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic

Nashville, Tennessee 37232

United States

Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro

Buenos Aires,

Argentina

Monash University-Monash Medical Centre (MMC)

Melbourne,

Australia

Royal Melbourne Hospital

Parkville,

Australia

Royal North Shore Hospital (RNSH)

Saint Leonards,

Australia

Adults Westmead Hospital

Westmead,

Australia

University Health Network - Toronto General Hospital - Osteoporosis Clinic

Toronto, Ontario M5G 2C4

Canada

Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade

Aarhus,

Denmark

Odense Universitetshospital

Odense,

Denmark

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