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

August 13, 2026 updated by: Angitia Incorporated Limited

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro
        • Principal Investigator:
          • Maria Belen Zanchetta
  • Australia
      • Melbourne, Australia
        • Recruiting
        • Monash University-Monash Medical Centre (MMC)
        • Principal Investigator:
          • Chin Yao Tan
      • Parkville, Australia
        • Recruiting
        • Royal Melbourne Hospital
        • Principal Investigator:
          • Cherie Chiang
      • Saint Leonards, Australia
        • Recruiting
        • Royal North Shore Hospital (RNSH)
        • Principal Investigator:
          • Roderick Clifton-Bligh
      • Westmead, Australia
        • Not yet recruiting
        • Adults Westmead Hospital
        • Principal Investigator:
          • Christian Girgis
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network - Toronto General Hospital - Osteoporosis Clinic
        • Principal Investigator:
          • Shirine Usmani
  • Denmark
      • Aarhus, Denmark
        • Not yet recruiting
        • Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade
        • Principal Investigator:
          • Bente Langdahl
      • Odense, Denmark
        • Not yet recruiting
        • Odense Universitetshospital
        • Principal Investigator:
          • Lars Folkestad
  • France
      • Lyon, France
        • Not yet recruiting
        • Hôpital Edouard Herriot
        • Principal Investigator:
          • Roland Chapurlat
      • Paris, France
        • Not yet recruiting
        • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
        • Principal Investigator:
          • Martine Cohen-Solal
  • Netherlands
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit
        • Principal Investigator:
          • Natasha Appelman
      • Rotterdam, Netherlands
        • Not yet recruiting
        • Erasmus MC
        • Principal Investigator:
          • Evert van Velsen
      • Zwolle, Netherlands
        • Not yet recruiting
        • Isala ziekenhuizen
        • Principal Investigator:
          • Hans Feenstra
  • United Kingdom
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital
        • Principal Investigator:
          • Kenneth Poole
      • Edinburgh, United Kingdom
        • Not yet recruiting
        • Lothian Health Board, Western General Hospital
        • Principal Investigator:
          • Stuart Ralston
      • London, United Kingdom
        • Not yet recruiting
        • Royal National Orthopaedic Hospital NHS Trust
        • Principal Investigator:
          • Richard Keen
      • Oxford, United Kingdom
        • Not yet recruiting
        • Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Kassim Javaid
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's
        • Principal Investigator:
          • Maegan Wallace
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine
        • Principal Investigator:
          • Peter Tebben
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Not yet recruiting
        • Nemours/Alfred I. duPont Hospital for Children
        • Principal Investigator:
          • Mahim Jain
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
        • Principal Investigator:
          • Eric Imel
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine in St. Louis
        • Principal Investigator:
          • Gary Gottesman
    • New Mexico
      • Albuquerque, New Mexico, United States, 87160
        • Recruiting
        • New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
        • Principal Investigator:
          • E. Michael Lewiecki
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • The Ohio State University Wexner Medical Center (OSUWMC)
        • Principal Investigator:
          • Steve Ing
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
        • Principal Investigator:
          • Eric Orwoll
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
        • Principal Investigator:
          • Kathryn Dahir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGA2115 Dose Regimen 1
Participants that complete the double-blind period receiving AGA2115 Dose 1 from study start to Month 12 will continue to a 12-month open-label period. Participants will then receive AGA2115 Dose 2 for Months 12 to 24.
Drug: AGA2115
Subcutaneous injection
Experimental: AGA2115 Dose Regimen 2
Participants that complete the double-blind period receiving AGA2115 Dose 2 from study start to Month 12 will continue to a 12-month open-label period. Participants will be kept on the same AGA2115 dose for Months 12 to 24.
Drug: AGA2115
Subcutaneous injection
Experimental: AGA2115 Dose Regimen 3
Participants that complete the double-blind period receiving AGA2115 Dose 3 from study start to Month 12 will continue to a 12-month open-label period. Participants will receive the same AGA2115 dose for Months 12 to 24.
Drug: AGA2115
Subcutaneous injection
Placebo Comparator: Placebo
Participants that complete the double-blind period receiving placebo from study start to Month 12 will continue to a 12-month open-label period. Participants will receive AGA2115 Dose 3 for Months 12 to 24.
Other: Placebo
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from Baseline at Month 12 in lumbar spine BMD
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from Baseline at Month 3 and 6 in lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Time Frame: 3 and 6 months
3 and 6 months
Percent change from Baseline at Month 12 in total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Time Frame: 12 months
12 months
Percent change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in P1NP and CTX-1
Time Frame: Week 1, Month 1, 3, 6, 9, and 12
Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures during the double-blind treatment period
Time Frame: up to 12 months
up to 12 months
Annualized fracture rate for incident fractures occurring during the double-blind treatment period (total, long-bone, vertebral, peripheral)
Time Frame: up to 12 months
up to 12 months

Other Outcome Measures

Outcome Measure
Time Frame
Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)
Time Frame: Baseline to 24 months
Baseline to 24 months
Evaluation of AGA2115 observed serum concentration levels for the AGA2115 treatment groups
Time Frame: Baseline to 24 months
Baseline to 24 months
Number of participants who develop anti-AGA2115 antibodies
Time Frame: Baseline to 24 months
Baseline to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angitia Incorporated Limited

Investigators

  • Study Director: Heather Byers, MD, Angitia Incorporated Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

July 1, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT24-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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