NCT06732895

A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.

A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of Navepegritide Administered Once Weekly for 52 Weeks in Adolescents (12-18 Years of Age) With Achondroplasia.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ascendis Pharma A/S · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

• Achondroplasia

Interventions

Type	Name	Description
DRUG	Navepegritide	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

Timeline

• Start date: 2024-12-10
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2024-12-13
• Last updated: 2025-12-17

Locations

5 sites across 5 countries: Canada, Denmark, France, Ireland, United Kingdom

Regulatory

• FDA-regulated drug study