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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: Inpegsomatropin Injection; Drug: Inpegsomatropin Injection; Drug: Inpegsomatropin Injection; Drug: Placebo for Inpegsomatropin Injection; Drug: Placebo for Inpegsomatropin Injection; Drug: Placebo for Inpegsomatropin Injection

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yiming Li, Ph.D; Phone Number: 13501936597; Email: yimingli@fudan.edu.cn

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
    • Contact: Junqing Zhang
  • Henan, China
    • The First Affiliated Hospital of Henan University of Science and Technology
    • Contact: Hongwei Jiang
  • Shanghai, China
    • Huashan Hospital, Fudan University
    • Contact: Yiming Li, Ph.D; Phone Number: 13501936597; Email: yimingli@fudan.edu.cn
    • Contact: Yiming Li; Phone Number: 13501936597; Email: yimingli@fudan.edu.cn
  • Sichuan, China
    • West China Hospital, Sichuan University
    • Contact: Ping Feng
    • Contact: Huiwen Tan
  • Xiamen, China
    • The First Affiliated Hospital of Xiamen University
    • Contact: Xuejun Li
  • Zhejiang, China
    • The Second Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: Chao Zheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group: Inpegsomatropin Injection low dose	Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week; Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week; Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week
Placebo Comparator: A group:Placebo for Inpegsomatropin Injection low dose	Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week; Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week; Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee
Experimental: B group: Inpegsomatropin Injection middle dose	Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week; Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week; Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week
Placebo Comparator: B group:Placebo for Inpegsomatropin Injection middle dose	Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week; Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week; Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee
Experimental: C group: Experimental:telpegfilgrastim Injection high	Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week; Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week; Drug: Inpegsomatropin Injection; Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week
Placebo Comparator: C group:Placebo for Inpegsomatropin Injection high dose	Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week; Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week; Drug: Placebo for Inpegsomatropin Injection; Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Event	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Serious Adverse Event	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of Participants with Abnormal Laboratory Parameters Findings	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
HR (bpm)	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
PR (ms)	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QRS (ms)	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QT (ms)	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QTc (ms)	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of participants with clinically significant changes in imaging examinations	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body weight	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body Mass Index	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body temperature	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
pulse	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
blood pressure	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Respiration	Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Trunk fat percentage	Week 25
Trunk fat mass	Week 25
Total fat mass	Week 25
Visceral adipose tissue (VAT)	Week 25
Lean body mass (LBM)	Week 25
Bone mineral density (BMD)	Week 25
Quality of life score (QoL score)	Week 25
BMI	Week1Day1,Week25Day1
Change from baseline in waist-to-hip ratio	Week3Day1,Week25Day1
IGF-I /IGFBP-3	Week1Day1,Week25Day1
Cmax	Week1Day1,Week25Day1
Cmin	Week1Day1,Week25Day1
Tmax	Week1Day1,Week25Day1
AUC0-t	Week1Day1,Week25Day1
AUC0-∞	Week1Day1,Week25Day1
AUC0-tau	Week1Day1,Week25Day1
Rac_Cmax	Week1Day1,Week25Day1
Rac_AUC0-tau	Week1Day1,Week25Day1
CL/F	Week1Day1,Week25Day1
Vz/F	Week1Day1,Week25Day1
DF	Week1Day1,Week25Day1
t1/2	Week1Day1,Week25Day1
ADA	Week1Day1,Week29Day1
NAb	Week1Day1,Week29Day1

Collaborators and Investigators

• Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Investigators: Principal Investigator: Yiming Li, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetic; Inpegsomatropin Injection; Adults With Growth Hormone Deficiency
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Bone Diseases, Endocrine; Bone Diseases, Developmental; Dwarfism; Hypopituitarism; Dwarfism, Pituitary
• Other Study ID Numbers: PEGPESEN-4-3-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No