What this study is
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
What's being tested
- AGA2115
Intervention · DRUG
- Placebo
Intervention · OTHER
Both interventions
Subcutaneous injection
Study details
- Official title
- 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
- Conditions
- Osteogenesis Imperfecta (OI)
- Enrolling
- 80 people
- Starts
- 2025-12-12
- Est. completion
- 2029-02
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (26)
26 openPhoenix Children's
Phoenix, Arizona, United States
- Maegan Wallace · Principal investigator
RecruitingYale University School of Medicine
New Haven, Connecticut, United States
- Peter Tebben · Principal investigator
RecruitingNemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
- Mahim Jain · Principal investigator
RecruitingIndiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
Indianapolis, Indiana, United States
- Eric Imel · Principal investigator
RecruitingWashington University School of Medicine in St. Louis
St Louis, Missouri, United States
- Gary Gottesman · Principal investigator
Not yet recruitingNew Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
Albuquerque, New Mexico, United States
- E. Michael Lewiecki · Principal investigator
RecruitingThe Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, United States
- Steve Ing · Principal investigator
RecruitingOregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
Portland, Oregon, United States
- Eric Orwoll · Principal investigator
RecruitingVanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
Nashville, Tennessee, United States
- Kathryn Dahir · Principal investigator
Not yet recruiting
17 sites outside the US
Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro
Buenos Aires, Argentina
- Maria Belen Zanchetta · Principal investigator
RecruitingMonash University-Monash Medical Centre (MMC)
Melbourne, Australia
- Chin Yao Tan · Principal investigator
RecruitingRoyal Melbourne Hospital
Parkville, Australia
- Cherie Chiang · Principal investigator
RecruitingRoyal North Shore Hospital (RNSH)
Saint Leonards, Australia
- Roderick Clifton-Bligh · Principal investigator
RecruitingAdults Westmead Hospital
Westmead, Australia
- Christian Girgis · Principal investigator
Not yet recruitingUniversity Health Network - Toronto General Hospital - Osteoporosis Clinic
Toronto, Ontario, Canada
- Shirine Usmani · Principal investigator
RecruitingAarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade
Aarhus, Denmark
- Bente Langdahl · Principal investigator
Not yet recruitingOdense Universitetshospital
Odense, Denmark
- Lars Folkestad · Principal investigator
Not yet recruitingHopital Edouard Herriot
Lyon, France
- Roland Chapurlat · Principal investigator
Not yet recruitingAssistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
Paris, France
- Martine Cohen-Solal · Principal investigator
Not yet recruitingLeiden University Medical Center (LUMC) - Centrum voor botkwaliteit
Leiden, Netherlands
- Natasha Appelman · Principal investigator
Not yet recruitingErasmus MC
Rotterdam, Netherlands
- Evert van Velsen · Principal investigator
Not yet recruitingIsala ziekenhuizen
Zwolle, Netherlands
- Hans Feenstra · Principal investigator
Not yet recruitingCambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital
Cambridge, United Kingdom
- Kenneth Poole · Principal investigator
Not yet recruitingLothian Health Board, Western General Hospital
Edinburgh, United Kingdom
- Stuart Ralston · Principal investigator
RecruitingRoyal National Orthopaedic Hospital NHS Trust
London, United Kingdom
- Richard Keen · Principal investigator
RecruitingOxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
- Kassim Javaid · Principal investigator
Not yet recruiting
Study team
Sponsor
Angitia Incorporated Limited
Study ID ACT24-001
Study director
Heather Byers, MD
Angitia Incorporated Limited
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.