BioinvestGPT

BioinvestGPT ApS · Research use only

NCT06433557 (Navepegritide in children with achondroplasia): BVCT ex-ante prediction vs. reported outcome

On 29 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 9 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient.

Clinical Trial

NCTID
NCT06433557
Acronym
COACH
Drug Name
Navepegritide
Drug MoA
long-lasting c-type natriuretic peptide
Drug Modality
peptide
Drug Class
Best-In-Class
Therapeutic Area
Musculoskeletal Diseases
Indication
children with achondroplasia (ACH)
Human Patients
22
Sponsor
Ascendis Pharma
Phase
Phase 2

Prediction of , index 1776

Prospective Prediction
Prediction Index
1776
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in AGV at least numerically superior to vosoritide)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in AGV against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
284 days in advance
Readout Data Interpretation
navepegritide + lonapegsomatropin achieved 9.14cm/year mean AGV for treatment-naive patients; superior to vosoritide’s 4cm/year mean AGV for treatment-naive patients (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 2
Status
Active not recruiting
Enrollment
22
Lead sponsor
Ascendis Pharma Growth Disorders A/S
Conditions
Achondroplasia
Interventions
DRUG: Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections
Design
Single group · None
Primary purpose
Treatment
Start
2024-07-26
Primary completion
2025-11-14
Completion
2027-11
Primary outcomes
  • Annualized growth velocity (Week 52)
  • Treatment-emergent adverse events (TEAEs). (Throughout the trial for 156 weeks)

NCT06433557 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials