Osteogenesis Imperfecta (OI)Phase 2EIRNCT07557446
A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)
A Phase 2 study testing AGA2115 in people with Osteogenesis Imperfecta (OI), run by Angitia Biopharmaceuticals Guangzhou Limited at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Osteogenesis Imperfecta (OI)
- What is being tested?
- AGA2115
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesChina
- Study dates
- 14 Jul 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Mei Li
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Zhongjian Xie
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Zhenlin Zhang
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
Kai Tsun Michael To
- Not yet recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215025
Ting Chen
About this study
Official 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
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).
Read the 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.
- Conditions
- Osteogenesis Imperfecta (OI)
- Being tested
- AGA2115
- Keywords
- Osteogenesis Imperfecta, dose regimen finding, Phase 2
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGA2115Drug
Participants will receive AGA2115 administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Adult participants will receive AGA2115 Dose Regimen 1. Receives: Drug: AGA2115 |
| Cohort 2 | Experimental | Adult participants will receive AGA2115 Dose Regimen 2. Receives: Drug: AGA2115 |
| Cohort 3 | Experimental | Adult participants will receive AGA2115 Dose Regimen 3. Receives: 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. Receives: Drug: AGA2115 |
| Cohort 6 | Experimental | Adolescent participants will receive AGA2115 Dose Regimen 2. Receives: Drug: AGA2115 |
| Cohort 7 | Experimental | Adolescent participants will receive AGA2115 Dose Regimen 3. Receives: Drug: AGA2115 |
| Cohort 8 | No intervention | Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures between Baseline and Month 12
Measured: Baseline to Month 12
Annualized fracture rate for incident fractures occurring between Baseline and Month 12
Measured: Baseline to Month 12
AGA2115 observed concentration for the treatment groups
Measured: 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
Measured: Day 1 to Month 27 (Cohorts 1 and 5); Day 1 to Month 24 (Cohorts 2, 3, 4, 6, 7 and 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start14 Jul 2026
- Primary completionApr 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis Imperfecta (OI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angitia Biopharmaceuticals Guangzhou Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557446
- Sponsor's protocol ID
- ACT24-003
- Acronym
- EIR
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07557446
- Acronym / sponsor ID
- EIR / ACT24-003
- Conditions
- Osteogenesis Imperfecta (OI)
- Keywords
- Osteogenesis Imperfecta, dose regimen finding, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Angitia Biopharmaceuticals Guangzhou LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AGA2115Adult participants will receive AGA2115 Dose Regimen 1. |
| Cohort 2 | Experimental | Drug: AGA2115Adult participants will receive AGA2115 Dose Regimen 2. |
| Cohort 3 | Experimental | Drug: AGA2115Adult participants will receive AGA2115 Dose Regimen 3. |
| Cohort 4 | No intervention | –Adult participants will only receive AGA2115 Dose Regimen 2 in the second year. |
| Cohort 5 | Experimental | Drug: AGA2115Adolescent participants will receive AGA2115 Dose Regimen 1. |
| Cohort 6 | Experimental | Drug: AGA2115Adolescent participants will receive AGA2115 Dose Regimen 2. |
| Cohort 7 | Experimental | Drug: AGA2115Adolescent participants will receive AGA2115 Dose Regimen 3. |
| Cohort 8 | No intervention | –Adolescent participants will only receive AGA2115 Dose Regimen 2 in the second year. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGA2115Participants will receive AGA2115 administered by subcutaneous injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
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)
7 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGA2115 in people with Osteogenesis Imperfecta (OI), run by Angitia Biopharmaceuticals Guangzhou Limited at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yolanda Liu (+86 13911537795, yolanda.liu@angitiabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.