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New shot aims to fortify fragile bones in brittle bone disease trial

NCT ID NCT07062588

Disease control Sponsor: Angitia Incorporated Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This study tests a drug called AGA2115 in 80 adults with osteogenesis imperfecta (brittle bone disease) types I, III, or IV. Participants receive either the drug or a placebo as a shot under the skin. The main goal is to see if the drug increases bone density in the spine after 12 months, which could lead to stronger bones and fewer fractures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AGA2115 (a drug given as a shot under the skin)
What this could lead to
If it works, this could point toward a new treatment to strengthen bones and reduce fractures in people with brittle bone disease.
What could go wrong
This is an early Phase 2 trial with only 80 people, so results may not apply to everyone. The drug may not improve bone density more than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 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 * 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)

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Conditions

The condition(s) this trial relates to.

osteogenesis imperfecta osteogenesis imperfecta type 1 osteogenesis imperfecta type 3 osteogenesis imperfecta type 4

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteogenesis imperfecta (OI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade

    NOT_YET_RECRUITING

    Aarhus, Denmark

  • Adults Westmead Hospital

    NOT_YET_RECRUITING

    Westmead, Australia

  • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

    NOT_YET_RECRUITING

    Paris, France

  • Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital

    NOT_YET_RECRUITING

    Cambridge, United Kingdom

  • Erasmus MC

    NOT_YET_RECRUITING

    Rotterdam, Netherlands

  • Hopital Edouard Herriot

    NOT_YET_RECRUITING

    Lyon, France

  • Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro

    RECRUITING

    Buenos Aires, Argentina

  • Isala ziekenhuizen

    NOT_YET_RECRUITING

    Zwolle, Netherlands

  • Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit

    NOT_YET_RECRUITING

    Leiden, Netherlands

  • Lothian Health Board, Western General Hospital

    NOT_YET_RECRUITING

    Edinburgh, United Kingdom

  • Monash University-Monash Medical Centre (MMC)

    RECRUITING

    Melbourne, Australia

  • Nemours/Alfred I. duPont Hospital for Children

    NOT_YET_RECRUITING

    Wilmington, Delaware, 19803, United States

  • New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)

    RECRUITING

    Albuquerque, New Mexico, 87160, United States

  • Odense Universitetshospital

    NOT_YET_RECRUITING

    Odense, Denmark

  • Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic

    RECRUITING

    Portland, Oregon, 97239, United States

  • Oxford University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Oxford, United Kingdom

  • Phoenix Children's

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Australia

  • Royal National Orthopaedic Hospital NHS Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • Royal North Shore Hospital (RNSH)

    RECRUITING

    Saint Leonards, Australia

  • The Ohio State University Wexner Medical Center (OSUWMC)

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • University Health Network - Toronto General Hospital - Osteoporosis Clinic

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine in St. Louis

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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