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NCT Number: NCT07551804

Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency

This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.

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Key information

Conditions

Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Peking University First Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Surgical resection of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening;
  • 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.

Treatment and study plan

Inpegsomatropin Injection

Drug

Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week

Placebo for Inpegsomatropin Injection

Drug

Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week

Primary outcomes

  1. Adverse Event

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  2. Serious Adverse Event

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  3. Number of Participants with Abnormal Laboratory Parameters Findings

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  4. HR (bpm)

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  5. PR (ms)

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  6. QRS (ms)

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  7. QT (ms)

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  8. QTc (ms)

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  9. Number of participants with clinically significant changes in imaging examinations

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  10. body weight

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  11. body Mass Index

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  12. body temperature

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  13. pulse

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  14. blood pressure

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  15. Respiration

    Time frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37

  16. Trunk fat percentage

    Time frame: Week 25

  17. Trunk fat mass

    Time frame: Week 25

  18. Total fat mass

    Time frame: Week 25

  19. Visceral adipose tissue (VAT)

    Time frame: Week 25

  20. Lean body mass (LBM)

    Time frame: Week 25

  21. Bone mineral density (BMD)

    Time frame: Week 25

  22. Quality of life score (QoL score)

    Time frame: Week 25

  23. BMI

    Time frame: Week1Day1,Week25Day1

  24. Change from baseline in waist-to-hip ratio

    Time frame: Week3Day1,Week25Day1

  25. IGF-I /IGFBP-3

    Time frame: Week1Day1,Week25Day1

  26. Cmax

    Time frame: Week1Day1,Week25Day1

  27. Cmin

    Time frame: Week1Day1,Week25Day1

  28. Tmax

    Time frame: Week1Day1,Week25Day1

  29. AUC0-t

    Time frame: Week1Day1,Week25Day1

  30. AUC0-∞

    Time frame: Week1Day1,Week25Day1

  31. AUC0-tau

    Time frame: Week1Day1,Week25Day1

  32. Rac_Cmax

    Time frame: Week1Day1,Week25Day1

  33. Rac_AUC0-tau

    Time frame: Week1Day1,Week25Day1

  34. CL/F

    Time frame: Week1Day1,Week25Day1

  35. Vz/F

    Time frame: Week1Day1,Week25Day1

  36. DF

    Time frame: Week1Day1,Week25Day1

  37. t1/2

    Time frame: Week1Day1,Week25Day1

  38. ADA

    Time frame: Week1Day1,Week29Day1

  39. NAb

    Time frame: Week1Day1,Week29Day1

Study contacts

Contact information is provided by the study sponsor or research team.

Yiming Li, Ph.D

CONTACT

[email protected]

13501936597

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Registry information

Official study title

A Multiple-Dose, Dose-Escalation, Randomized, Double-Blind, Placebo-Controlled Phase Ⅱa Clinical Trial to Evaluate the Safety, Pharmacokinetic (PK) Profile and Preliminary Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 27, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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