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New shot aims to toughen fragile bones in rare disease

NCT ID NCT07557446

Disease control Sponsor: Angitia Biopharmaceuticals Guangzhou 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 2 trial tests a drug called AGA2115 in 48 Chinese adults and adolescents with osteogenesis imperfecta (types I, III, IV), a condition that makes bones brittle. Participants receive one of three dose schedules by injection under the skin. The study checks for side effects and measures changes in bone density over 12 months.

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 injected under the skin to strengthen bones)
What this could lead to
If successful, this could point toward a new treatment to improve bone density and reduce fractures in people with osteogenesis imperfecta.
What could go wrong
This is an early-phase trial with only 48 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve bone strength significantly.

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 48 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

12 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: * 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.

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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 places running it

    4 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Children's Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, 215025, China

  • Chinese Academy of Medical Sciences, Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100005, China

  • Shanghai Sixth People's Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200233, China

  • The University of Hong Kong-Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.