A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.
NCT06732895 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-04-21
Summary
The purpose of this clinical trial is to evaluate efficacy and safety of once weekly subcutaneous (SC) doses of navepegritide 100 μg/kg compared to placebo (inactive drug) in adolescents aged 12 to 18 years with Achondroplasia. What will be measured is Annualized Growth Velocity after a 52-week treatment period.
Conditions
Interventions
- DRUG
-
Once-weekly subcutaneous injection of 100 µg/kg navepegritide for 52 weeks
- DRUG
-
Placebo for navepegritide
Once-weekly subcutaneous injection of 100 µg/kg placebo for navepegritide
Sponsors & Collaborators
-
Ascendis Pharma A/S
lead INDUSTRY
Principal Investigators
-
Medical Director, MD · Ascendis Pharma A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-10
- Primary Completion
- 2027-08-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- Canada
- Denmark
- France
- Ireland
- United Kingdom
Study Locations
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