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Growth Hormone

Lonapegsomatropin vs Somatropin for Turner Syndrome

Phase 2
Recruiting
Research Sponsored by Ascendis Pharma Endocrinology Division A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
AHV< 6 cm/year or <25ᵗʰ percentile over a time span of 6-18 months for children of 2 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks, 52 weeks and 104 weeks
Awards & highlights

Study Summary

This trial tests a long-acting growth hormone product given once/wk vs daily injections in kids with Turner Syndrome in the US. 48 kids (12/arm) will be randomized.

Who is the study for?
This trial is for prepubertal children aged 1-10 with Turner syndrome, confirmed by genetic testing. They must be new to growth hormone therapy and have impaired growth as per specific criteria. Children can't join if they have Y-chromosomal material without gonadectomy, diabetes, certain medical conditions affecting growth, or a history of malignancy.Check my eligibility
What is being tested?
The study compares different doses of Lonapegsomatropin (a long-acting weekly injection) against daily injections of Somatropin in treating Turner syndrome's growth impairment over 104 weeks. It will include about 48 participants across the United States who are randomly assigned to one of four groups.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, headaches, muscle pain, and possible development or worsening of scoliosis. Long-term use might affect glucose metabolism leading to increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on stable hormone replacement therapy, except for growth hormone, for over 4 weeks.
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My child's height velocity is less than 6 cm/year or below the 25th percentile for their age.
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My thyroid function is normal, with or without medication.
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My eye exam showed no signs of high brain pressure or serious retina problems.
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I have never been treated with growth hormone or growth hormone secretagogues.
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I have been diagnosed with TS through a genetic test.
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I have not yet gone through puberty.
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I can sign the consent form myself, or my guardian can.
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I am between 1 and 10 years old.
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My bone age matches my actual age, within a 20% range.
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My height is below the 10th percentile for my age and sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks, 52 weeks and 104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks, 52 weeks and 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Annualized Height Velocity (AHV) (cm/year)
Change from baseline in Bone age (calculated years)
Change from baseline in height standard deviation score (SDS)
+1 more
Other outcome measures
Insulin-like growth factor 1 (IGF-1) standard deviation score (SDS)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Lonapegsomatropin at 0.36 mg hGH/kg/weekExperimental Treatment1 Intervention
Lonapegsomatropin at 0.36 mg hGH/kg/week administered once-weekly by subcutaneous injection
Group II: Lonapegsomatropin at 0.30 mg hGH/kg/weekExperimental Treatment1 Intervention
Lonapegsomatropin at 0.30 mg hGH/kg/week administered once-weekly by subcutaneous injection
Group III: Lonapegsomatropin at 0.24 mg hGH/kg/weekExperimental Treatment1 Intervention
Lonapegsomatropin at 0.24 mg hGH/kg/week administered once-weekly by subcutaneous injection
Group IV: Somatropin at 0.05 mg/kg/dayActive Control1 Intervention
Somatropin at 0.05 mg/kg/day administered once-daily by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lonapegsomatropin
2020
Completed Phase 3
~270

Find a Location

Who is running the clinical trial?

Ascendis Pharma Endocrinology Division A/SLead Sponsor
6 Previous Clinical Trials
2,205 Total Patients Enrolled

Media Library

Lonapegsomatropin (Growth Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT05690386 — Phase 2
Turner Syndrome Research Study Groups: Lonapegsomatropin at 0.24 mg hGH/kg/week, Lonapegsomatropin at 0.30 mg hGH/kg/week, Lonapegsomatropin at 0.36 mg hGH/kg/week, Somatropin at 0.05 mg/kg/day
Turner Syndrome Clinical Trial 2023: Lonapegsomatropin Highlights & Side Effects. Trial Name: NCT05690386 — Phase 2
Lonapegsomatropin (Growth Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05690386 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to minors?

"This research project is looking for participants that are younger than 10 years of age and older than a year."

Answered by AI

How many established healthcare facilities are conducting this research?

"Currently, 17 research sites are participating in this clinical trial. These locations stretch across the country from Palo Alto to Aurora and San Diego as well as 14 other cities. To minimize travel requirements, it is best to choose a site nearest you if you decide to join the study."

Answered by AI

Is Lonapegsomatropin dosage of 0.24 mg hGH/kg/week safe for patients?

"Currently, Lonapegsomatropin administered in doses of 0.24 mg hGH/kg/week is evaluated to be relatively safe with a score of 2 due to Phase 2 trial data indicating some evidence for safety but no efficacy results yet."

Answered by AI

Does this trial have vacancies for participants at present?

"Clinicaltrials.gov reports that this medical study, which initial posting was on January 1st 2023, is not actively enrolling participants at the moment. However, there are 1369 other clinical trials currently in progress and open to patient recruitment."

Answered by AI

Could I register to participate in this clinical trial?

"This clinical trial is seeking 48 prepubertal children who have been diagnosed with Turner Syndrome and are between 1 - 10 years of age. Additional criteria must be met by participants, including having a height lower than the 10th percentile for sex/age according to 2000 CDC Growth Charts for America, bone age at no more than their chronological age on left wrist radiograph scans during screening, biochemically euthyroid without signs or symptoms of intracranial hypertension or proliferative retinopathy in fundoscopy screenings, and stable doses of hormone replacement therapies (other than growth hormones) taken four weeks prior to Screening onwards."

Answered by AI
~28 spots leftby Oct 2025