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Active, not recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05690386

Public ClinicalTrials.gov record NCT05690386. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 11:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05690386
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Enrollment
48 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
1 Year to 10 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 15, 2023 (Actual)
Primary completion
Oct 18, 2024 (Actual)
Completion
Dec 2027 (Estimated)
Last update posted
May 13, 2026

2023 – 2027

United States locations

U.S. sites
19
U.S. states
16
U.S. cities
19
Facility City State ZIP Site status
Ascendis Pharma Investigational Site Palo Alto California 94304 —
Ascendis Pharma Investigational Site San Diego California 92123 —
Ascendis Pharma Investigational Site Aurora Colorado 80045 —
Ascendis Pharma Investigational Site Orlando Florida 32827 —
Ascendis Pharma Investigational Site St. Petersburg Florida 33701-4804 —
Ascendis Pharma Investigational Site Atlanta Georgia 30322 —
Ascendis Pharma Investigational Site Idaho Falls Idaho 83404 —
Ascendis Pharma Investigational Site Chicago Illinois 60611 —
Ascendis Pharma Investigational Site Boston Massachusetts 02114 —
Ascendis Pharma Investigational Site Saint Paul Minnesota 55102 —
Ascendis Pharma Investigational Site Las Vegas Nevada 89113 —
Ascendis Pharma Investigational Site Lake Success New York 11042 —
Ascendis Pharma Investigational Site Chapel Hill North Carolina 27599 —
Ascendis Pharma Investigational Site Cincinnati Ohio 45229 —
Ascendis Pharma Investigational Site Oklahoma City Oklahoma 73104 —
Ascendis Pharma Investigational Site Portland Oregon 97239 —
Ascendis Pharma Investigational Site El Paso Texas 79902 —
Ascendis Pharma Investigational Site Fort Worth Texas 76104 —
Ascendis Pharma Investigational Site Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05690386, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2026 · Synced Oct 18, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05690386 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →