RecruitingPhase 2NCT07062588

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

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)

Sponsor

Angitia Incorporated Limited

Enrollment

80 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Osteogenesis Imperfecta (OI)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AGA2115 and Placebo for people with osteogenesis imperfecta (oi). The study is currently recruiting participants at 26 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAGA2115

Subcutaneous injection

OTHERPlacebo

Subcutaneous injection

Locations(26)

Phoenix Children's

Phoenix, Arizona, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

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

Indianapolis, Indiana, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

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

Albuquerque, New Mexico, 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

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, 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

View Full Details on ClinicalTrials.gov

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NCT07062588

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