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

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 Phase 2 interventional trial compares three dosing regimens of AGA2115 to a control in Chinese participants aged 12–75 with OI types I, III, or IV. Participants are randomized 1:1:1:1 to the four arms during the first year, then all receive AGA2115 with ongoing safety and efficacy assessments through 24–27 months. The study includes bone-health assessments and monitoring for adverse events to determine a tolerable and effective dose strategy. Enrollment focuses on confirmed COL1A1/COL1A2 mutation carriers with documented bone mineral density criteria. Eligibility excludes significant metabolic or skeletal disorders beyond OI and active thyroid or calcium abnormalities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults (18-75 years) or adolescents (12-17 years) with a confirmed diagnosis of Osteogenesis Imperfecta (OI) Type I, III, or IV with genetic confirmation of pathogenic variants in COL1A1 or COL1A2 genes
* BMD T-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adults) or BMD Z-score of ≤-1.0 at the lumbar spine, total hip, or femoral neck (adolescents)
* 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

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, osteomalacia, or other significant skeletal disorders (excluding OI) leading to long-bone deformities and/or increased risk of fractures.
* Use of bisphosphonates within the past 6 months.
* Use of teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months.
* Use of denosumab (or denosumab biosimilars) within the past 2 years.
* Use of 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 or within 4 months after the last dose of IP.

Where it's running

• Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• The University of Hong Kong-Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Not yet recruiting
• Children's Hospital of Soochow University
  Suzhou, Jiangsu, China Not yet recruiting
• Shanghai Sixth People's Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Yolanda Liu
• Email: yolanda.liu@angitiabio.com
• Phone: +86 13911537795

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

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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.