Easy-to-Use Growth Hormone Deficiency Treatment: A New Injectable for Adults

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 trial is a randomized, double-blind, placebo-controlled study in adults with growth hormone deficiency. Participants receive ascending doses of Inpegsomatropin or placebo in a 3:1 ratio within each dose cohort, after a multi-dose schedule. The study aims to characterize safety, pharmacokinetics, and preliminary efficacy in up to 36 participants across multiple sites in China. Key outcomes include safety signals and hormonal markers, with responses tracked over the dosing period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male study participants aged ≥ 18 years and \< 80 years at the time of signing the informed consent form (ICF);
* Study participants meeting the criteria for adult growth hormone deficiency (AGHD):

Patients with a peak GH level \< 5 μg/L measured by insulin tolerance test (ITT); OR Patients with an IGF-1 level below -2.0 SDS for age and sex at screening (see Appendix 4);

* No systemic treatment with growth hormone or growth hormone secretagogues within 6 months prior to entering the screening period;
* For patients with any other pituitary hormone deficiency who are on hormone replacement therapy (HRT) at screening, HRT must have been stable for at least 3 months;
* Study participants must agree to use reliable contraceptive measures with their spouses from - Study participants fully understand the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in the study, and have signed the informed consent form.

Exclusion Criteria:

* Individuals with known or suspected hypersensitivity to the investigational product or its excipients;
* Patients with severe malnutrition as judged by the investigator, or with a BMI \< 18.5 kg/m² at screening;
* Patients with active malignancy or a history of malignancy; or with thyroid nodules classified as TI-RADS grade ≥ 4a on thyroid ultrasound; or with high-risk or suspected malignant nodules detected on chest CT; or with clinically significant abnormal tumor markers at screening;
* For patients with a history of pituitary adenoma or other benign intracranial tumors:

  1. Surgical resection of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening;
  2. Evidence of growth of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening (must be confirmed by two postoperative MRI scans, with the most recent MRI scan performed ≤ 6 months before the screening period);
* Patients with abnormal liver or renal function at screening (ALT \> 3×ULN, Cr \> 1.5×ULN);
* Patients testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibody (anti-HIV) at screening;
* Patients with a clinically significant change in body weight within 6 months prior to screening as judged by the investigator, or with a self-reported body weight change of ≥ 10% compared to 6 months before screening;
* Patients with unstable control of diabetes mellitus within 3 months prior to screening (HbA1c ≥ 7.5% at screening), or with significant adjustment of hypoglycemic medication dose or change in therapeutic drug type, or with severe diabetic complications as judged by the investigator;
* Patients with cardiac insufficiency classified as NYHA class ≥ III;
* Patients with a history of acromegaly or gigantism;
* Patients with mental disability or language impairment that prevents full participation in the trial;
* Individuals who have participated in any clinical trial of investigational medicinal products (as a trial participant) and received investigational intervention within 3 months prior to screening;
* Other conditions deemed unsuitable for enrollment by the investigator.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting
• The First Affiliated Hospital of Henan University of Science and Technology
  Henan, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, China Recruiting
• West China Hospital, Sichuan University
  Sichuan, China Recruiting
• The First Affiliated Hospital of Xiamen University
  Xiamen, China Recruiting
• The Second Affiliated Hospital, Zhejiang University School of Medicine
  Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yiming Li — Huashan Hospital
• Study coordinator: Yiming Li, Ph.D
• Email: yimingli@fudan.edu.cn
• Phone: 13501936597

Similar studies

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

• GenSci134 in healthy adults and adults with growth hormone deficiency

  This Phase 1 trial will test single and multiple subcutaneous doses of GenSci134 in healthy adults and single doses in adults with growth hormone deficiency to check safety, tolerability, pharmacokinetics, pharmacodynamics, and immune response.

  Recruiting Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07016802

• Belgians and Luxembourgians with childhood GHD: adult outcomes and follow-up

  This study tests how adults who had childhood-onset growth hormone deficiency and were treated with rhGH fare in follow-up and ongoing treatment.

  Recruiting Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Brussels, Woluwe-saint-lambert · NCT06694506

• Growth hormone therapy for veterans with Gulf War Illness and hormone deficiency

  This study is testing if growth hormone therapy can help veterans with Gulf War Illness and hormone deficiency feel better by reducing symptoms like fatigue and pain.

  Recruiting at 2 sites Phase 2 Baylor College of Medicine · Houston, Texas and 1 other locations · NCT05355272

• Growth hormone therapy for veterans with mild brain injuries and hormone deficiency

  This study is testing if growth hormone therapy can help improve the quality of life for veterans with mild brain injuries and hormone deficiency.

  Recruiting at 5 sites Phase 3 VA Office of Research and Development · Birmingham, Alabama and 15 other locations · NCT04867317

• Understanding growth hormone deficiency after a brain injury in adults

  This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.

  Recruiting University of Calgary · Calgary, Alberta and 1 other locations · NCT07795736

• Observational study on the effectiveness and safety of SKYTROFA for growth hormone deficiency

  This study is testing how well and safely SKYTROFA works for people with growth hormone deficiency by looking at their experiences during regular treatment.

  Recruiting at 27 sites Ascendis Pharma A/S · Phoenix, Arizona and 26 other locations · NCT05820672

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.