Recruiting
Phase 2

AGA2115

Sponsor:

Angitia Incorporated Limited

Code:

NCT07062588

Conditions

Osteogenesis Imperfecta (OI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AGA2115

Placebo

Study Details

Brief summary:

This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.

Conditions

Osteogenesis Imperfecta (OI)

Study ID

NCT07062588

Start date

Dec 12, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AGA2115 Dose Regimen 1

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.

experimental: AGA2115 Dose Regimen 2

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.

experimental: AGA2115 Dose Regimen 3

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.

placebo comparator: Placebo

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.

Interventions

AGA2115

Subcutaneous injection

Placebo

Subcutaneous injection

Primary outcome measure

  • Percent change from Baseline at Month 12 in lumbar spine BMD [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Kimberly Brown

818-862-2068clinicaltrials@angitiabio.com

Locations

Phoenix Children's

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Maegan Wallace

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Peter Tebben

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

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Eric Imel

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

Recruiting

Albuquerque, New Mexico, United States, 87160

Principal Investigator:

E. Michael Lewiecki

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

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Eric Orwoll

University Health Network - Toronto General Hospital - Osteoporosis Clinic

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Shirine Usmani

More Information

Sponsor

Angitia Incorporated Limited

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Angitia Incorporated Limited on 2026-08-17.