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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Osteogenesis Imperfecta (OI)
• Intervention / Treatment: Drug: AGA2115

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yolanda Liu; Phone Number: +86 13911537795; Email: yolanda.liu@angitiabio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100005
      • Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
      • Principal Investigator: Mei Li
  • Guangdong
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong-Shenzhen Hospital
      • Principal Investigator: Kai Tsun Michael To
  • Jiangsu
    • Suzhou, Jiangsu, China, 215025
      • Children's Hospital of Soochow University
      • Principal Investigator: Ting Chen
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200233
      • Shanghai sixth people's hospital
      • Principal Investigator: Zhenlin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Adult participants will receive AGA2115 Dose Regimen 1.	Drug: AGA2115; Participants will receive AGA2115 administered by subcutaneous injection
Experimental: Cohort 2; Adult participants will receive AGA2115 Dose Regimen 2.	Drug: AGA2115; Participants will receive AGA2115 administered by subcutaneous injection
Experimental: Cohort 3; Adult participants will receive AGA2115 Dose Regimen 3.	Drug: AGA2115; Participants will receive AGA2115 administered by subcutaneous injection
No Intervention: Cohort 4; Adult participants will only receive AGA2115 Dose Regimen 2 in the second year.
Experimental: Cohort 5; Adolescent participants will receive AGA2115 Dose Regimen 1.	Drug: AGA2115; Participants will receive AGA2115 administered by subcutaneous injection
Experimental: Cohort 6; Adolescent participants will receive AGA2115 Dose Regimen 2.	Drug: AGA2115; Participants will receive AGA2115 administered by subcutaneous injection
Experimental: Cohort 7; Adolescent participants will receive AGA2115 Dose Regimen 3.	Drug: AGA2115; Participants will receive AGA2115 administered by subcutaneous injection
No Intervention: Cohort 8; Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of Treatment-Emergent Adverse Events (TEAEs)	Baseline to Month 27 (Cohorts 1 and 5); Baseline to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8)

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	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.	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	Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures between Baseline and Month 12	Baseline to Month 12
Annualized fracture rate for incident fractures occurring between Baseline and Month 12	Baseline to Month 12
AGA2115 observed concentration for the treatment groups	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	Day 1 to Month 27 (Cohorts 1 and 5); Day 1 to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8).

Collaborators and Investigators

• Sponsor: Angitia Biopharmaceuticals Guangzhou Limited

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Phase 2; Osteogenesis Imperfecta; dose regimen finding
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Collagen Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Osteogenesis Imperfecta
• Other Study ID Numbers: ACT24-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No