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

NCT07557446 | Not Yet Recruiting Phase 2

• 1 other identifier: ACT24-003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

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).

Conditions

Osteogenesis Imperfecta (OI)

Keywords

Osteogenesis Imperfecta; dose regimen finding; Phase 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (8)

Cohort 1

EXPERIMENTAL

Adult participants will receive AGA2115 Dose Regimen 1.

Drug: AGA2115

Cohort 2

EXPERIMENTAL

Adult participants will receive AGA2115 Dose Regimen 2.

Drug: AGA2115

Cohort 3

EXPERIMENTAL

Adult participants will receive AGA2115 Dose Regimen 3.

Drug: AGA2115

Cohort 4

NO INTERVENTION

Adult participants will only receive AGA2115 Dose Regimen 2 in the second year.

Cohort 5

EXPERIMENTAL

Adolescent participants will receive AGA2115 Dose Regimen 1.

Drug: AGA2115

Cohort 6

EXPERIMENTAL

Adolescent participants will receive AGA2115 Dose Regimen 2.

Drug: AGA2115

Cohort 7

EXPERIMENTAL

Adolescent participants will receive AGA2115 Dose Regimen 3.

Drug: AGA2115

Cohort 8

NO INTERVENTION

Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year.

Interventions

AGA2115 DRUG

Participants will receive AGA2115 administered by subcutaneous injection

Cohort 1; Cohort 2; Cohort 3; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angitia Biopharmaceuticals Guangzhou Limited: lead

Study Sites (4)

Chinese Academy of Medical Sciences, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215025, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yolanda Liu

CONTACT

+86 13911537795; yolanda.liu@angitiabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)