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

NCT07062588 | Recruiting Phase 2 FDA Drug

• 1 other identifier: ACT24-001
• Study Type: interventional
• Target: 80
• Locations: 8 countries
• Sites: 27

Brief Summary

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

Conditions

Osteogenesis Imperfecta (OI)

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (5)

• 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

  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

  12 months

• Percent change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in P1NP and CTX-1

  Week 1, Month 1, 3, 6, 9, and 12

• Percentage of participants with fractures during the double-blind treatment period

  up to 12 months

• Annualized fracture rate for incident fractures occurring during the double-blind treatment period (total, long-bone, vertebral, peripheral)

  up to 12 months

Other Outcomes (3)

• Assessment of TEAEs (collection and documentation of all adverse events occurring during the study)

  Baseline to 24 months

• Evaluation of AGA2115 observed serum concentration levels for the AGA2115 treatment groups

  Baseline to 24 months

• Number of participants who develop anti-AGA2115 antibodies

  Baseline to 24 months

Study Arms (4)

AGA2115 Dose Regimen 1

EXPERIMENTAL

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

AGA2115 Dose Regimen 2

EXPERIMENTAL

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

AGA2115 Dose Regimen 3

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo OTHER

Subcutaneous injection

Placebo

AGA2115 DRUG

Subcutaneous injection

AGA2115 Dose Regimen 1; AGA2115 Dose Regimen 2; AGA2115 Dose Regimen 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Angitia Incorporated Limited: lead

Study Sites (27)

Phoenix Children's

Phoenix, Arizona, 85016, United States

NOT YET RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

NOT YET RECRUITING

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

Indianapolis, Indiana, 46202, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

University of Nebraska Medical Center (UNMC) - Diabetes and Endocrinology Center

Omaha, Nebraska, 68131, United States

NOT YET RECRUITING

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

Albuquerque, New Mexico, 87160, United States

RECRUITING

The Ohio State University Wexner Medical Center (OSUWMC)

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

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

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro

Buenos Aires, Argentina

NOT YET RECRUITING

Monash University-Monash Medical Centre (MMC)

Melbourne, Australia

NOT YET RECRUITING

Royal Melbourne Hospital

Parkville, Australia

NOT YET RECRUITING

Royal North Shore Hospital (RNSH)

Saint Leonards, Australia

NOT YET RECRUITING

Adults Westmead Hospital

Westmead, Australia

NOT YET RECRUITING

University Health Network - Toronto General Hospital - Osteoporosis Clinic

Toronto, Ontario, M5G 2C4, Canada

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

NOT YET RECRUITING

Royal National Orthopaedic Hospital NHS Trust

London, United Kingdom

NOT YET RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Heather Byers, MD

  Angitia Incorporated Limited

  STUDY DIRECTOR

Central Study Contacts

Kimberly Brown

CONTACT

818-862-2068; clinicaltrials@angitiabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 14, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

AR (1); CA (1); US (10); DK (2); NL (3); GB (4); AU (4); FR (2)