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

July 21, 2026 updated by: Xiamen Amoytop Biotech Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Junqing Zhang
      • Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Hongwei Jiang
      • Shanghai, China
      • Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Ping Feng
        • Contact:
          • Huiwen Tan
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Xuejun Li
      • Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Chao Zheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse Event
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Serious Adverse Event
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of Participants with Abnormal Laboratory Parameters Findings
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
HR (bpm)
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
PR (ms)
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QRS (ms)
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QT (ms)
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
QTc (ms)
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Number of participants with clinically significant changes in imaging examinations
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body weight
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body Mass Index
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
body temperature
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
pulse
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
blood pressure
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Respiration
Time Frame: Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Day -1,Weeks 1, 3, 5, 9, 17, 25, 29, 37
Trunk fat percentage
Time Frame: Week 25
Week 25
Trunk fat mass
Time Frame: Week 25
Week 25
Total fat mass
Time Frame: Week 25
Week 25
Visceral adipose tissue (VAT)
Time Frame: Week 25
Week 25
Lean body mass (LBM)
Time Frame: Week 25
Week 25
Bone mineral density (BMD)
Time Frame: Week 25
Week 25
Quality of life score (QoL score)
Time Frame: Week 25
Week 25
BMI
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Change from baseline in waist-to-hip ratio
Time Frame: Week3Day1,Week25Day1
Week3Day1,Week25Day1
IGF-I /IGFBP-3
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Cmax
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Cmin
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Tmax
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
AUC0-t
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
AUC0-∞
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
AUC0-tau
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Rac_Cmax
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Rac_AUC0-tau
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
CL/F
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
Vz/F
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
DF
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
t1/2
Time Frame: Week1Day1,Week25Day1
Week1Day1,Week25Day1
ADA
Time Frame: Week1Day1,Week29Day1
Week1Day1,Week29Day1
NAb
Time Frame: Week1Day1,Week29Day1
Week1Day1,Week29Day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Amoytop Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yiming Li, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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