NCT07557446 A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)
| NCT ID | NCT07557446 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Angitia Biopharmaceuticals Guangzhou Limited |
| Condition | Osteogenesis Imperfecta (OI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-06 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2026-06 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to evaluate the safety and efficacy of AGA2115 at three different dose regimens in Chinese adults and adolescents with Type I, III, or IV Osteogenesis imperfecta (OI).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07557446 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 75 Years, studying Osteogenesis Imperfecta (OI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07557446 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07557446 currently recruiting?
Yes, NCT07557446 is actively recruiting participants. Contact the research team at yolanda.liu@angitiabio.com for enrollment information.
Where is the NCT07557446 trial being conducted?
This trial is being conducted at Beijing, China, Shenzhen, China, Suzhou, China, Shanghai, China.
Who is sponsoring the NCT07557446 clinical trial?
NCT07557446 is sponsored by Angitia Biopharmaceuticals Guangzhou Limited. The trial plans to enroll 48 participants.