Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07557446

A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Osteogenesis Imperfecta (OI) Bone Diseases Bone Diseases, Developmental Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Osteogenesis Imperfecta Skin and Connective Tissue Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGA2115

Drug

Participants will receive AGA2115 administered by subcutaneous injection

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Percentage of participants with fractures between Baseline and Month 12

    Time frame: Baseline to Month 12

  5. Annualized fracture rate for incident fractures occurring between Baseline and Month 12

    Time frame: Baseline to Month 12

  6. 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).

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yolanda Liu

CONTACT

[email protected]

+86 13911537795

Sponsors and collaborators

Lead sponsor

Angitia Biopharmaceuticals Guangzhou Limited

Industry

Registry information

Official study title

A Phase 2 Multi-center, Randomized, Open-Label, Dose Regimen-Finding Study of AGA2115 in Chinese Adults and Adolescents With Type I, III, or IV Osteogenesis Imperfecta

Acronym: EIR

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 29, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.