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COACH: Navepegritide and Lonapegsomatropin in Children with Achondroplasia
NCT06433557Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2024
- Primary completion
- Nov 2025
- Countries
- 3
- Sponsor
- Ascendis Pharma
- Modality
- Peptides, Recombinant Proteins and Enzymes, Prodrugs/Conditional Activator Small Molecules
- Conditions
- achondroplasia (ACH)
01
Overview
Phase 2, open-label, single-arm trial of navepegritide and lonapegsomatropin in achondroplasia (ACH), sponsored by Ascendis Pharma. Primary endpoints: Annualized Growth Velocity at 52 weeks and Treatment-Emergent Adverse Events at 156 weeks. Started Jul 2024; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Combination of Navepegritide and Lonapegsomatropin
Single-arm receiving separate subcutaneous injections of both drugs once weekly.
03
Who it enrols
Children aged 2-11 with genetically confirmed achondroplasia, open epiphyses, and at least 6 months of growth history from specified prior studies or medical records.
04
Endpoints
Primary
Annualized Growth Velocity
Treatment-Emergent Adverse Events
Secondary
Annualized Growth Velocity
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