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NCT05690386 (Lonapegsomatropin in Turner Syndrome): BVCT ex-ante prediction vs. reported outcome

On 29 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 Dec 2024 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
NCT05690386
Acronym
New InsiGHTS
Drug Name
Lonapegsomatropin
Drug MoA
long-lasting growth hormone
Drug Modality
peptide
Drug Class
Best-In-Class
Therapeutic Area
Urogenital Diseases
Indication
Turner Syndrome
Human Patients
48
Sponsor
Ascendis Pharma
Phase
Phase 2

Prediction of , index 1129

Prospective Prediction
Prediction Index
1129
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit superior to daily somatropin)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
109 days in advance
Readout Data Interpretation
lonapegsomatropin met the primary endpoint of annualized height velocity at week 26; similar to daily somatropin
Press Release
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
New InsiGHTS: A Multicenter, Phase 2, Randomized, Open-label, Active-controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability, and Efficacy of Different Dose Levels of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Individuals With Turner Syndrome
Phase
Phase 2
Status
Active not recruiting
Enrollment
48
Lead sponsor
Ascendis Pharma Endocrinology Division A/S
Conditions
Turner Syndrome
Interventions
BIOLOGICAL: Lonapegsomatropin; DRUG: Somatropin
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-02-15
Primary completion
2024-10-18
Completion
2027-12
Primary outcomes
  • Annualized Height Velocity (AHV) (cm/year) (26 weeks)

NCT05690386 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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