NCT07062588 Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
| NCT ID | NCT07062588 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Angitia Incorporated Limited |
| Condition | Osteogenesis Imperfecta (OI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-12 |
| Primary Completion | 2027-11 |
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 80 participants in total. It began in 2025-12-12 with a primary completion date of 2027-11.
⚠ 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 will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Eligibility Criteria
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)
Contact & Investigator
Heather Byers, MD
STUDY DIRECTOR
Angitia Incorporated Limited
Frequently Asked Questions
Who can join the NCT07062588 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT07062588 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 NCT07062588 currently recruiting?
Yes, NCT07062588 is actively recruiting participants. Contact the research team at clinicaltrials@angitiabio.com for enrollment information.
Where is the NCT07062588 trial being conducted?
This trial is being conducted at Phoenix, United States, New Haven, United States, Wilmington, United States, Indianapolis, United States and 11 additional locations.
Who is sponsoring the NCT07062588 clinical trial?
NCT07062588 is sponsored by Angitia Incorporated Limited. The principal investigator is Heather Byers, MD at Angitia Incorporated Limited. The trial plans to enroll 80 participants.