Osteogenesis Imperfecta (OI)Phase 2IDUNNCT07062588
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
A Phase 2 study testing AGA2115 in people with Osteogenesis Imperfecta (OI), run by Angitia Incorporated Limited at 26 sites in 8 countries.
Trial summary
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo. Read more about this study
- Who is it for?
- Ages 18 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?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 12 Dec 2025to Feb 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes
- 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
- BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck
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 or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
- Treatment with bisphosphonates within the past 6 months
- Treatment with teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months
Show all 12Show fewer
- Treatment with denosumab (or denosumab biosimilars) within the past 2 years
- Treatment with 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
- Participation in any clinical study within the past 12 months during which the participant was administered any IP (participant must also agree not to enroll in any other clinical study concurrently in which IP is administered)
Trial locations and contacts
26 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 8 countries
United States9 sites, 9 recruiting
- Recruiting
New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
Albuquerque, New Mexico, 87160
E. Michael Lewiecki
- Recruiting
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, 43210
Steve Ing
- Recruiting
Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
Indianapolis, Indiana, 46202
Eric Imel
- Not yet recruiting
Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
Nashville, Tennessee, 37232
Kathryn Dahir
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
Peter Tebben
- Recruiting
Phoenix Children's
Phoenix, Arizona, 85016
Maegan Wallace
- Recruiting
Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
Portland, Oregon, 97239
Eric Orwoll
- Not yet recruiting
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
Gary Gottesman
- Recruiting
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
Mahim Jain
Australia4 sites, 4 recruiting
- Recruiting
Monash University-Monash Medical Centre (MMC)
Melbourne
Chin Yao Tan
- Recruiting
Royal Melbourne Hospital
Parkville
Cherie Chiang
- Recruiting
Royal North Shore Hospital (RNSH)
Saint Leonards
Roderick Clifton-Bligh
- Not yet recruiting
Adults Westmead Hospital
Westmead
Christian Girgis
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital
Cambridge
Kenneth Poole
- Recruiting
Lothian Health Board, Western General Hospital
Edinburgh
Stuart Ralston
- Recruiting
Royal National Orthopaedic Hospital NHS Trust
London
Richard Keen
- Not yet recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
Kassim Javaid
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit
Leiden
Natasha Appelman
- Not yet recruiting
Erasmus MC
Rotterdam
Evert van Velsen
- Not yet recruiting
Isala ziekenhuizen
Zwolle
Hans Feenstra
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade
Aarhus
Bente Langdahl
- Not yet recruiting
Odense Universitetshospital
Odense
Lars Folkestad
France2 sites, 2 recruiting
- Not yet recruiting
Hopital Edouard Herriot
Lyon
Roland Chapurlat
- Not yet recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
Paris
Martine Cohen-Solal
Argentina1 site, 1 recruiting
- Recruiting
Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro
Buenos Aires
Maria Belen Zanchetta
Canada1 site, 1 recruiting
- Recruiting
University Health Network - Toronto General Hospital - Osteoporosis Clinic
Toronto, Ontario, M5G 2C4
Shirine Usmani
About this study
Official title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Read the detailed description
This Phase 2 dose-ranging study will evaluate the safety and efficacy of AGA2115 at a range of doses in adults with Type I, III, or IV osteogenesis imperfecta. The study will last 27 months with a 24-month treatment period and a 3-month follow-up period. During the first 12 months of the study, participants will be randomized 1:1:1:1 to receive either placebo or one of three dose levels of AGA2115 doses; treatment assignment will be double-blind. Months 12 to 24 will be open-label, and all participants will receive AGA2115. Participants will attend visits where safety and efficacy parameters will be evaluated.
- Conditions
- Osteogenesis Imperfecta (OI)
- Being tested
- AGA2115, Placebo
- 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
Subcutaneous injection
PlaceboOther
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| AGA2115 Dose Regimen 1 | Experimental | Participants that complete the double-blind period receiving AGA2115 Dose 1 from study start to Month 12 will continue to a 12-month open-label period. Participants will then receive AGA2115 Dose 2 for Months 12 to 24. Receives: Drug: AGA2115 |
| AGA2115 Dose Regimen 2 | Experimental | Participants that complete the double-blind period receiving AGA2115 Dose 2 from study start to Month 12 will continue to a 12-month open-label period. Participants will be kept on the same AGA2115 dose for Months 12 to 24. Receives: Drug: AGA2115 |
| AGA2115 Dose Regimen 3 | Experimental | Participants that complete the double-blind period receiving AGA2115 Dose 3 from study start to Month 12 will continue to a 12-month open-label period. Participants will receive the same AGA2115 dose for Months 12 to 24. Receives: Drug: AGA2115 |
| Placebo | Placebo comparator | Participants that complete the double-blind period receiving placebo from study start to Month 12 will continue to a 12-month open-label period. Participants will receive AGA2115 Dose 3 for Months 12 to 24. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Baseline at Month 12 in lumbar spine BMD
Measured: 12 months
Secondary outcomes (5)
Percent change from Baseline at Month 3 and 6 in lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Measured: 3 and 6 months
Percent change from Baseline at Month 12 in total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Measured: 12 months
Percent change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in P1NP and CTX-1
Measured: Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures during the double-blind treatment period
Measured: up to 12 months
Annualized fracture rate for incident fractures occurring during the double-blind treatment period (total, long-bone, vertebral, peripheral)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start12 Dec 2025
- Primary completionNov 2027 (estimated)
- Study completionFeb 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angitia Incorporated Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heather Byers, MD, Study director, Angitia Incorporated Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062588
- Sponsor's protocol ID
- ACT24-001
- Acronym
- IDUN
- Status last verified
- Nov 2026
- First submitted
- 1 Jul 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults With Type I, III, or IV Osteogenesis Imperfecta (OI)
- ClinicalTrials.gov ID
- NCT07062588
- Acronym / sponsor ID
- IDUN / ACT24-001
- Conditions
- Osteogenesis Imperfecta (OI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Angitia Incorporated LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 14 Jul 2025 (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 will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
Detailed description
This Phase 2 dose-ranging study will evaluate the safety and efficacy of AGA2115 at a range of doses in adults with Type I, III, or IV osteogenesis imperfecta. The study will last 27 months with a 24-month treatment period and a 3-month follow-up period. During the first 12 months of the study, participants will be randomized 1:1:1:1 to receive either placebo or one of three dose levels of AGA2115 doses; treatment assignment will be double-blind. Months 12 to 24 will be open-label, and all participants will receive AGA2115. Participants will attend visits where safety and efficacy parameters will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AGA2115 Dose Regimen 1 | Experimental | Drug: AGA2115Participants that complete the double-blind period receiving AGA2115 Dose 1 from study start to Month 12 will continue to a 12-month open-label period. Participants will then receive AGA2115 Dose 2 for Months 12 to 24. |
| AGA2115 Dose Regimen 2 | Experimental | Drug: AGA2115Participants that complete the double-blind period receiving AGA2115 Dose 2 from study start to Month 12 will continue to a 12-month open-label period. Participants will be kept on the same AGA2115 dose for Months 12 to 24. |
| AGA2115 Dose Regimen 3 | Experimental | Drug: AGA2115Participants that complete the double-blind period receiving AGA2115 Dose 3 from study start to Month 12 will continue to a 12-month open-label period. Participants will receive the same AGA2115 dose for Months 12 to 24. |
| Placebo | Placebo comparator | Other: PlaceboParticipants that complete the double-blind period receiving placebo from study start to Month 12 will continue to a 12-month open-label period. Participants will receive AGA2115 Dose 3 for Months 12 to 24. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults (aged 18 to 75 years inclusive) with a clinical diagnosis of osteogenesis imperfecta Type I, III, or IV with documented genetic testing confirmation of genetic variations in the COL1A1 or COL1A2 genes
- 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
- BMD T-score of ≤ -1.0 at the lumbar spine, total hip, or femoral neck
Key exclusion criteria (12 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 or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
- Treatment with 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 |
|---|---|---|
| AGA2115Subcutaneous injection | Drug | AGA2115 Dose Regimen 1, AGA2115 Dose Regimen 2, AGA2115 Dose Regimen 3 |
| PlaceboSubcutaneous injection | Other | Placebo |
Primary outcome
Percent change from Baseline at Month 12 in lumbar spine BMD
Time frame: 12 months
5 secondary outcomes
Percent change from Baseline at Month 3 and 6 in lumbar spine, total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Time frame: 3 and 6 months
Percent change from Baseline at Month 12 in total hip, femoral neck, one-third distal radius, and total body (minus head) BMD
Time frame: 12 months
Percent change from Baseline at Week 1 and Month 1, 3, 6, 9, and 12 in P1NP and CTX-1
Time frame: Week 1, Month 1, 3, 6, 9, and 12
Percentage of participants with fractures during the double-blind treatment period
Time frame: up to 12 months
Annualized fracture rate for incident fractures occurring during the double-blind treatment period (total, long-bone, vertebral, peripheral)
Time frame: up to 12 months
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 4 Nov 2026.
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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.
Heather Byers, MD study director
Angitia Incorporated Limited
26 sites in 8 countries: 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 Incorporated Limited at 26 sites in 8 countries.
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 12 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Australia, United Kingdom, Netherlands, Denmark and 3 more countries. 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. Some participants in this study may receive a placebo. 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 Kimberly Brown (818-862-2068, clinicaltrials@angitiabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from Baseline at Month 12 in lumbar spine BMD (time frame: 12 months). 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 4 Nov 2026.