Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)

Conditions

• Osteogenesis Imperfecta (OI)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• AGA2115 — DRUG
  Subcutaneous injection
• Placebo — OTHER
  Subcutaneous injection

Study Details

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

Key Dates

Start date

Dec 12, 2025

Status verified

May 2026

Primary completion

Nov 30, 2027

Completion

Feb 28, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Kimberly Brown
  818-862-2068
  [email protected]

Locations (10)

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