AGA2115 for Brittle Bone Disease
(IDUN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AGA2115 to determine its effectiveness for adults with brittle bone disease, or osteogenesis imperfecta (OI). The study examines three different doses of AGA2115, comparing them to a placebo (a treatment with no active drug) over two years. Adults with a confirmed diagnosis of OI Types I, III, or IV, and specific genetic markers, are suitable candidates for this trial. Participants should not have other conditions affecting bone health or have recently taken certain bone-related treatments. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AGA2115 has been tested in healthy individuals to assess its safety. In these early studies, AGA2115 was generally well-tolerated, with most participants experiencing no serious side effects. Some reported mild issues, but these were not major concerns.
The treatment also demonstrated positive effects on bone mineral density, suggesting potential benefits for strengthening bones, which is crucial for individuals with brittle bone disease. Since AGA2115 is in Phase 2 trials, it has already passed early safety tests. This phase aims to further understand the drug's efficacy and safety in people with osteogenesis imperfecta.
In summary, early tests indicate that AGA2115 appears safe. It is designed to enhance bone strength, and current research focuses on confirming these benefits and ensuring safety for those with brittle bone disease.12345Why do researchers think this study treatment might be promising for brittle bone disease?
Most treatments for brittle bone disease, also known as osteogenesis imperfecta, focus on strengthening bones and reducing fractures, typically using bisphosphonates like pamidronate or alendronate. But AGA2115 works differently by targeting a novel pathway that directly influences bone density and strength. This unique mechanism has the potential to more effectively enhance bone resilience compared to existing therapies. Researchers are excited because AGA2115 might offer a new level of protection against fractures, potentially improving the quality of life for patients with brittle bone disease. Additionally, the study includes different dosing regimens, which might help identify the most effective and safe way to administer this promising treatment.
What evidence suggests that this trial's treatments could be effective for brittle bone disease?
Research has shown that AGA2115 can help increase bone strength, which is crucial for treating brittle bone disease, also known as osteogenesis imperfecta. In this trial, participants will receive different dose regimens of AGA2115 or a placebo. Studies have found that higher doses of this treatment lead to greater improvements in bone strength. Early results from human studies showed a quick increase in new bone growth and a decrease in bone breakdown, which together strengthen bones. The treatment has proven to be safe. These early findings suggest AGA2115 could be a promising option for people with types I, III, or IV of this condition.12367
Who Is on the Research Team?
Ann Zovein, MD
Principal Investigator
Angitia Incorporated Limited
Are You a Good Fit for This Trial?
Adults aged 18-75 with Type I, III, or IV osteogenesis imperfecta (brittle bone disease) and a BMD T-score of ≤ -1.0. Participants must have genetic variations in COL1A1 or COL1A2 confirmed by testing and be able to consent to the trial's requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either placebo or one of three dose levels of AGA2115 for 12 months in a double-blind manner
Open-label Treatment
All participants receive AGA2115 in an open-label manner for an additional 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AGA2115
- Placebo
Trial Overview
The IDUN trial is testing AGA2115 against a placebo to see its effects on adults with certain types of brittle bone disease. The goal is to determine if AGA2115 can improve their condition compared to not receiving the active drug.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Angitia Incorporated Limited
Lead Sponsor
Citations
ANGITIA - INNOVATION FOR PATIENTS
Clinical data demonstrated administration of AGA2115 drove dose-dependent increases in bone mineral density. - The Company and collaborators ...
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With ...
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo. Detailed Description.
Angitia Biopharmaceuticals Announces Dosing of First ...
Angitia presented first-in-human data on AGA2115 in healthy volunteers at the American Society for Bone and Mineral Research (ASBMR) 2025 Annual ...
Angitia Biopharmaceuticals to Present Data on AGA2115 ...
Angitia Biopharmaceuticals to Present Data on AGA2115 for Osteogenesis Imperfecta at ASBMR 2025. Press Release. By: Ref: GlobeNewswire.
Angitia Biopharmaceuticals Announces Topline Results ...
This FIH study of AGA2115 demonstrated a favorable safety profile with a rapid increase in bone formation and simultaneous decrease in bone resorption.
A First-in-Human Study Evaluating AGA2115 in Adult ...
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
A First-in-Human Study Evaluating AGA2115 in Adult ...
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers. Eligibility. Inclusion Criteria: Healthy men and women ≥18 to ≤65 years old.
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