AGA2115 treatment for adults with osteogenesis imperfecta caused by COL1A1 or COL1A2 variants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 dose-ranging, randomized, double-blind study for the first 12 months followed by a 12-month open-label period and a 3-month follow-up, totaling 27 months. Adults with Type I, III, or IV osteogenesis imperfecta and documented COL1A1 or COL1A2 variants who meet bone density criteria will be randomized 1:1:1:1 to placebo or one of three AGA2115 dose levels for 12 months. From months 12–24 all participants receive AGA2115 in an open-label fashion, with regular visits to monitor safety and efficacy measures. The trial excludes people with vitamin D deficiency, certain endocrine or metabolic bone conditions, recent bisphosphonate use, or other conditions that could affect bone metabolism.

Why it matters

Who can join: the full rules

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)

Where it's running

• Phoenix Children's
  Phoenix, Arizona, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• Nemours/Alfred I. duPont Hospital for Children
  Wilmington, Delaware, United States Recruiting
• Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
  Indianapolis, Indiana, United States Recruiting
• New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
  Albuquerque, New Mexico, United States Recruiting
• The Ohio State University Wexner Medical Center (OSUWMC)
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Kimberly Brown
• Email: clinicaltrials@angitiabio.com
• Phone: 818-862-2068

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dose-finding study of AGA2115 in Chinese adults and adolescents with osteogenesis imperfecta

  This study tests three different dosing regimens of AGA2115 in Chinese adults and adolescents with Osteogenesis Imperfecta to see how safe it is and how well it works.

  Recruiting at 2 sites Phase 2 Angitia Biopharmaceuticals · Beijing, Beijing Municipality and 4 other locations · NCT07557446

• Heart structure and function in children and adults with Osteogenesis Imperfecta

  This project will follow children and adults with Osteogenesis Imperfecta to see how their heart structure and function change over a five-year period.

  Recruiting Istituto Ortopedico Rizzoli · Bologna, Emilia-Romagna · NCT07287241

• Using REMS ultrasound to check bone density in children and teens with conditions that lower bone strength

  This project will test whether REMS, a radiation-free ultrasound method, can measure bone mineral density in children and adolescents aged 5–18 who have conditions that weaken their bones.

  Recruiting Meyer Children's Hospital IRCCS · Florence, Tuscany · NCT07412782

• Pediatric safety follow-up after romosozumab treatment for osteogenesis imperfecta

  This follow-up tests the safety of romosozumab in children and adolescents with osteogenesis imperfecta who previously received romosozumab in an earlier trial.

  Recruiting at 4 sites Phase 3 Amgen · Indianapolis, Indiana and 3 other locations · NCT07366086

• Adapted physical activity program for children and teenagers with Osteogenesis Imperfecta

  This study tests if a special 6-month exercise program can help children and teenagers with Osteogenesis Imperfecta improve their energy levels and overall fitness.

  Recruiting University Hospital, Toulouse · Montpellier and 1 other locations · NCT05927389

• Evaluating hearing and balance in children and young adults with Osteogenesis Imperfecta

  This study is testing how Osteogenesis Imperfecta affects hearing and balance in kids and young adults aged 12 to 20 to better understand the condition's impact.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT05419960

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.