A Phase 2 interventional study of AGA2115 in Osteogenesis Imperfecta (OI), sponsored by Angitia Biopharmaceuticals Guangzhou Limited. Recruiting at 5 sites in China. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Angitia Biopharmaceuticals Guangzhou Limited · Phase 2, Interventional, and Treatment
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).
This Phase 2 study will evaluate the safety and efficacy of AGA2115 in three different dosing regimens in Chinese adults and adolescents with Type I, III, or IV OI. Participants will be in the study for 24 or 27 months depending on their assigned cohort. During the first 12 months of the study, adult and adolescent participants will be randomized separately in a 1:1:1:1 ratio to one of three AGA2115 dosing regimens or control cohort. During months 12 to 24 or 27, all participants will receive AGA2115 and attend visits for the evaluation of safety and efficacy parameters.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's planned enrollment of 48 is above the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →This is the only study on the registry with Angitia Biopharmaceuticals Guangzhou Limited as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants will receive AGA2115 Dose Regimen 1.
Drug: AGA2115
Adult participants will receive AGA2115 Dose Regimen 2.
Drug: AGA2115
Adult participants will receive AGA2115 Dose Regimen 3.
Drug: AGA2115
Adult participants will only receive AGA2115 Dose Regimen 2 in the second year.
Adolescent participants will receive AGA2115 Dose Regimen 1.
Drug: AGA2115
Adolescent participants will receive AGA2115 Dose Regimen 2.
Drug: AGA2115
Adolescent participants will receive AGA2115 Dose Regimen 3.
Drug: AGA2115
Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year.
Participants will receive AGA2115 administered by subcutaneous injection
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline to Month 27 (Cohorts 1 and 5); Baseline to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8)
Percent change from Baseline at Month 3, 6, 9 and 12 in Bone Mineral Density (BMD) at lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) for adults and adolescents.
Time frame: Months 3, 6, 9, and 12
Change from Baseline at Month 3, 6, 9, and 12 in BMD Z-score at lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) for adolescents.
Time frame: Month 3, 6, 9, and 12
Percent Change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in bone turnover markers CTX-1 and P1NP
Time frame: Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures between Baseline and Month 12
Time frame: Baseline to Month 12
Annualized fracture rate for incident fractures occurring between Baseline and Month 12
Time frame: Baseline to Month 12
AGA2115 observed concentration for the treatment groups
Time frame: Day 1 to Month 27 (Cohorts 1 and 5); Day 1 to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8).
Serum anti-AGA2115 antibodies
Time frame: Day 1 to Month 27 (Cohorts 1 and 5); Day 1 to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8).
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Apr 2028, 21 months after the start.
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Studies of the drug tested here: Humanized bispecific antibody neutralizing both sclerostin AND DICKKOPF-1 (AGA-2115)