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A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome | Clinical Trials | Clareo Health

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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

NCT05690386•Ascendis Pharma Endocrinology Division A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 10 years

Sex

FEMALE

Healthy Volunteers

No

Inclusion Criteria

•1. Age between 1 and 10 years, inclusive.
•2. TS diagnosis via genetic test.
•3. Prepubertal status.
•4. Naïve to growth hormone therapy or growth hormone secretagogue.
•5. Exhibit impaired growth defined by at least one of the following:
•1. AHV\< 6 cm/year or \<25ᵗʰ percentile over a time span of 6-18 months for children of 2 years and older.
•2. Height (or length for individuals \< 2 years old) \<10ᵗʰ percentile for sex and age according to the 2000 CDC Growth Charts for the United States.
•6. Bone age within normal limits for chronological age, defined as no more than 20% above or below chronological age in months or delayed for chronological age (greater than 20% below chronological age), at screening.
•7. Biochemically euthyroid (including when on thyroid hormone supplementation).
•8. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g. adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout Screening.
+13 more criteria

Exclusion Criteria

•1. Turner Syndrome with presence of Y-chromosomal material on genetic testing and without a history of gonadectomy.
•2. Diagnosis of diabetes mellitus.
•3. Known history of clinically relevant conditions that may have an effect on growth, e.g. but not limited to celiac disease, malnutrition, treatment with potential growth-influencing medications for Attention-deficit/ hyperactivity disorder (ADHD), etc.
•4. Any known, clinically significant, congenital or acquired cardiac/cardiovascular dysfunction that might interfere with growth as determined by transthoracic echocardiogram.
•5. Known history or presence of malignancy.
•6. Individuals with history of intracranial tumor or cysts, with evidence of growth within the last 12 months prior to Screening.

Locations (19)

Ascendis Pharma Investigational Site

Palo Alto, California, United States

Ascendis Pharma Investigational Site

San Diego, California, United States

Ascendis Pharma Investigational Site

Aurora, Colorado, United States

Ascendis Pharma Investigational Site

Orlando, Florida, United States

Ascendis Pharma Investigational Site

St. Petersburg, Florida, United States

Ascendis Pharma Investigational Site

Atlanta, Georgia, United States

Ascendis Pharma Investigational Site

Idaho Falls, Idaho, United States

Ascendis Pharma Investigational Site

Chicago, Illinois, United States

Ascendis Pharma Investigational Site

Boston, Massachusetts, United States

Ascendis Pharma Investigational Site

Saint Paul, Minnesota, United States

Key Dates

Start Date

February 15, 2023

Primary Completion Date

October 18, 2024

Completion Date

December 1, 2027

Last Updated

January 12, 2026

Enrollment

48

ACTUAL participants

Conditions

Turner Syndrome

Interventions

Lonapegsomatropin

BIOLOGICAL

Somatropin

DRUG

Sponsors

Lead Sponsor

Ascendis Pharma Endocrinology Division A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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