Inpegsomatropin vs Givopegsomatropin for short stature in girls with Turner syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial enrolls 84 prepubertal girls with Turner syndrome and short stature, stratified by age and karyotype. Participants are randomized 1:1 to receive either Inpegsomatropin-injection or Givopegsomatropin-solution injection for 52 weeks, in an open-label, positive-controlled design. Efficacy and safety will be assessed through growth measurements and safety monitoring to support a potential new indication. The study is conducted at multiple centers in China and uses bone age, height, and growth velocity as key endpoints. Eligible participants must have Turner syndrome confirmed by karyotype, be prepubertal, and not have recently used growth-promoting therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Prepubertal girls at Tanner stage I, with age ≥ 2 years and \< 12 years at the time of informed consent signature.
* With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).
* At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).
* At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.
* No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
* Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks.
* The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their assent shall be clearly documented.

Exclusion Criteria:

* Subjects with closed epiphyses.
* Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.
* Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.
* Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.
* Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening.
* Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc.
* Abnormal liver and renal function at screening (ALT \> 2 times the upper limit of normal; Cr \> upper limit of normal).
* Subjects with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol/L on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose tolerance judged by the investigator as unsuitable for participation in this study.
* Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B.
* Subjects with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders.
* Subjects with severe congenital skeletal dysplasia; or those with scoliosis \> 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis.
* Subjects with a prior history of intracranial hypertension.
* Subjects with a history of malignant tumor or current active malignant tumor, including intracranial tumors.
* Known hypersensitivity to growth hormone or its excipients.
* Subjects with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening.
* Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.

Where it's running

• Anyang Maternal and Child Health Hospital
  Anyang, China Recruiting
• Beijing Children's Hospital, Capital Medical University
  Beijing, China Recruiting
• Capital Institute of Pediatrics, Capital Medical University
  Beijing, China Recruiting
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting
• Peking University First Hospital
  Beijing, China Recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, China Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Xiaoping Luo — Tongji Hospital
• Study coordinator: Xiaoping Luo
• Email: xpluo@tjh.tjmu.edu.cn
• Phone: 15671671188

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Parental plans and pregnancy outcomes in 93 women with Turner syndrome

  This project describes parental plans and pregnancy outcomes for adult women with Turner syndrome treated at Strasbourg University Hospitals between 2009 and 2019.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07344012

• Once-weekly lonapegsomatropin versus daily somatropin for children and adolescents with short stature due to growth-hormone-sufficient conditions

  It will test whether a once-weekly injection of lonapegsomatropin helps children and teens with Turner syndrome, SHOX mutation, small-for-gestational-age, or idiopathic short stature grow as well as or better than daily somatropin.

  Recruiting at 56 sites Phase 3 Ascendis Pharma A/S · Phoenix, Arizona and 55 other locations · NCT07221851

• Bleeding patterns with sequential versus continuous progesterone in adolescents with Turner syndrome

  This study will test whether taking progesterone continuously or in a sequential (monthly) schedule changes bleeding patterns in adolescents with Turner syndrome who are on estrogen replacement therapy.

  Recruiting Phase 4 Children's Mercy Hospital Kansas City · Kansas City, Missouri · NCT06834594

• Investigating liver health in adults with Turner Syndrome

  This study looks at liver health in adults with Turner Syndrome to see how common liver problems are and what might cause them.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna · NCT06794190

• Exercise testing in girls with Turner Syndrome

  This study tests how well girls aged 8-18 with Turner Syndrome can exercise by measuring their heart and lung performance during a special exercise test.

  Recruiting University Hospital, Ghent · Ghent · NCT06780514

• Comparing oral and transdermal estrogen therapy in women with Turner syndrome

  This study is testing whether taking estrogen as a pill or through the skin is better for women with Turner syndrome in terms of their overall health and well-being.

  Recruiting Phase 4 University of Aarhus · Aarhus, Aarhus N · NCT06570460

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.