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

NCT07551804 | Not Yet Recruiting Phase 2

• 1 other identifier: PEGPESEN-4-3-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Adult Growth Hormone Deficiency

Keywords

Inpegsomatropin Injection; Pharmacokinetic; Safety; Adults With Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (39)

• 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

Study Arms (6)

A group: Inpegsomatropin Injection low dose

EXPERIMENTAL

Drug: Inpegsomatropin Injection

A group:Placebo for Inpegsomatropin Injection low dose

PLACEBO COMPARATOR

Drug: Placebo for Inpegsomatropin Injection

B group: Inpegsomatropin Injection middle dose

EXPERIMENTAL

Drug: Inpegsomatropin Injection

B group:Placebo for Inpegsomatropin Injection middle dose

PLACEBO COMPARATOR

Drug: Placebo for Inpegsomatropin Injection

C group: Experimental:telpegfilgrastim Injection high

EXPERIMENTAL

Drug: Inpegsomatropin Injection

C group:Placebo for Inpegsomatropin Injection high dose

PLACEBO COMPARATOR

Drug: Placebo for Inpegsomatropin Injection

Interventions

Inpegsomatropin Injection DRUG

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

A group: Inpegsomatropin Injection low dose

Placebo for Inpegsomatropin Injection DRUG

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

A group:Placebo for Inpegsomatropin Injection low dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead

Study Sites (5)

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Henan, China

Location

Huashan Hospital, Fudan University

Shanghai, China

Location

West China Hospital, Sichuan University

Sichuan, China

Location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang, China

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Yiming Li

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiming Li, Ph.D

CONTACT

13501936597; yimingli@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)