A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia (COACH)

NCT06433557 Phase 2 ACTIVE_NOT_RECRUITING

This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.

Details

Lead sponsor	Ascendis Pharma Growth Disorders A/S
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	22
Start date	2024-07-26
Completion	2027-11

Conditions

• Achondroplasia

Interventions

• Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections

Primary outcomes

• Annualized growth velocity — Week 52
  cm per year, compared to navepegritide alone
• Treatment-emergent adverse events (TEAEs). — Throughout the trial for 156 weeks
  safety profile of navepegritide and lonapegsomatropin

Countries

Denmark, Ireland, United Kingdom