Who is sponsoring NCT05690386?

NCT05690386 is sponsored by Ascendis Pharma Endocrinology Division A/S.

What condition does NCT05690386 study?

NCT05690386 studies Turner Syndrome.

What drugs are being tested in NCT05690386?

Interventions: Lonapegsomatropin, Somatropin.

What is the status of NCT05690386?

NCT05690386 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2026-05-12 · How we verify

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

NCT05690386 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Ascendis Pharma Endocrinology Division A/S
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	48
Start date	2023-02-15
Completion	2027-12

Conditions

Turner Syndrome

Interventions

Lonapegsomatropin
Somatropin

Primary outcomes

Annualized Height Velocity (AHV) (cm/year) — 26 weeks
Calculated based on the difference between the AHV at 6 months and baseline

Countries

United States