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A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia

Study acronym: COACH
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Sep 2025 to Nov 14, 2025
    • Study completion date: Sep 2027 to Nov 2027
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 22
    • Site details revised at 3 of 3 sites
    v6
  4. Site details revised at 1 of 3 sitesv5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jul 2025 to Sep 2025
    • Study completion date: Jul 2027 to Sep 2027
    • Start date changed from estimate of Jul 2024 to Jul 26, 2024
    • Site details revised at 3 of 3 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 2024 to Jul 2024v3
  2. Start date: May 2024 to Jun 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06433557
Lead Sponsor Ascendis Pharma Growth Disorders A/S
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov