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AGA2115 treatment for adults with osteogenesis imperfecta caused by COL1A1 or COL1A2 variants

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)

Phase 2 Interventional Angitia Biopharmaceuticals · NCT07062588

This will test whether the drug AGA2115 helps adults (18–75) with Type I, III, or IV osteogenesis imperfecta due to COL1A1 or COL1A2 genetic variants.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAngitia Biopharmaceuticals Industry-sponsored
Drugs / interventionsdenosumab, romosozumab, setrusumab, blosozumab
Locations27 sites (Phoenix, Arizona and 26 other locations)
Trial IDNCT07062588 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 dose-ranging, randomized, double-blind study for the first 12 months followed by a 12-month open-label period and a 3-month follow-up, totaling 27 months. Adults with Type I, III, or IV osteogenesis imperfecta and documented COL1A1 or COL1A2 variants who meet bone density criteria will be randomized 1:1:1:1 to placebo or one of three AGA2115 dose levels for 12 months. From months 12–24 all participants receive AGA2115 in an open-label fashion, with regular visits to monitor safety and efficacy measures. The trial excludes people with vitamin D deficiency, certain endocrine or metabolic bone conditions, recent bisphosphonate use, or other conditions that could affect bone metabolism.

Who should consider this trial

Good fit: Adults aged 18–75 with clinical Type I, III, or IV OI and confirmed COL1A1 or COL1A2 genetic variants who can give informed consent and have a BMD T-score ≤ -1.0 are ideal candidates.

Not a fit: People without COL1A1/COL1A2 variants, children, those with untreated vitamin D deficiency, uncontrolled endocrine disorders affecting bone, or recent bisphosphonate treatment are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, AGA2115 could improve bone density and reduce fracture risk or bone fragility in adults with genetically confirmed OI due to COL1A1/COL1A2 variants.

How similar studies have performed: Other medicines like bisphosphonates have shown bone-density benefits in OI, but AGA2115 is an investigational therapy and has not yet been proven effective for this genetic subgroup.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Phoenix, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Osteogenesis Imperfecta
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.