NCT05690386

A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ascendis Pharma Endocrinology Division A/S · Industry
• Sex: Female
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

Summary

A 104 week dose finding open label trial followed by an optional 78 week open label extension of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus daily somatropin product in prepubertal individuals with Turner syndrome. Approximately 48 individuals (12 individuals per arm) will be randomized to receive one of three doses of lonapegsomatropin or a daily injection of somatropin. This is a trial that will be conducted in the United States.

Conditions

• Turner Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Lonapegsomatropin	Once-weekly subcutaneous injection of Lonapegsomatropin
DRUG	Somatropin	Once-daily subcutaneous injection of Somatropin

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-10-18
• Completion: 2027-12-01
• First posted: 2023-01-19
• Last updated: 2026-01-12

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study