Adult Growth Hormone DeficiencyPhase 2NCT07551804

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

A Phase 2 study testing Inpegsomatropin Injection in people with Adult Growth Hormone Deficiency, run by Xiamen Amoytop Biotech Co., Ltd. at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Adult Growth Hormone Deficiency
What is being tested?: Inpegsomatropin Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 6 sitesChina
Study dates: 10 Jun 2026to 30 Jun 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yiming Li, Ph.D contact

13501936597

yimingli@fudan.edu.cn

City, postcode or hospital

Sites recruiting now only

6 sites in 1 country

China6 sites, 6 recruiting

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

Other trials in China

About this study

Official 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

Conditions: Adult Growth Hormone Deficiency
Being tested: Inpegsomatropin Injection, Placebo for Inpegsomatropin Injection
Keywords: Inpegsomatropin Injection, Pharmacokinetic, Safety, Adults With Growth Hormone Deficiency
Medical subject headings: Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inpegsomatropin InjectionDrug
Inpegsomatropin Injection,initial dose1mg/0.25ml, s.c. ,once a week
Placebo for Inpegsomatropin InjectionDrug
Placebo for Inpegsomatropin Injection,initial dose0.25ml, s.c. ,once a week
Inpegsomatropin InjectionDrug
Inpegsomatropin Injection,initial dose 2mg/0.5ml, s.c. ,once a week
Placebo for Inpegsomatropin InjectionDrug
Placebo for Inpegsomatropin Injection,initial dose 0.5ml, s.c. ,once a week
Inpegsomatropin InjectionDrug
Inpegsomatropin Injection,initial dose 4mg/1ml, s.c. ,once a week
Placebo for Inpegsomatropin InjectionDrug
Placebo for Inpegsomatropin Injection,initial dose 1.0ml, s.c. ,once a wee

Study groups in NCT07551804
Study group	Role	What they receive
A group: Inpegsomatropin Injection low dose	Experimental	Not described Receives: Drug: Inpegsomatropin Injection
A group:Placebo for Inpegsomatropin Injection low dose	Placebo comparator	Not described Receives: Drug: Placebo for Inpegsomatropin Injection
B group: Inpegsomatropin Injection middle dose	Experimental	Not described Receives: Drug: Inpegsomatropin Injection
B group:Placebo for Inpegsomatropin Injection middle dose	Placebo comparator	Not described Receives: Drug: Placebo for Inpegsomatropin Injection
C group: Experimental:telpegfilgrastim Injection high	Experimental	Not described Receives: Drug: Inpegsomatropin Injection
C group:Placebo for Inpegsomatropin Injection high dose	Placebo comparator	Not described Receives: Drug: Placebo for Inpegsomatropin Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202630 Jun 2028

First posted27 Apr 2026
Study start10 Jun 2026
Primary completion31 Dec 2027 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07551804
Sponsor's protocol ID: PEGPESEN-4-3-003
Status last verified: Jul 2026
First submitted: 15 Apr 2026
Last updated: 22 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Yiming Li, Ph.D

13501936597

yimingli@fudan.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Safety, Tolerability

All Adult Growth Hormone Deficiency trials