Not Yet RecruitingPhase 2

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

China36 participantsStarted 2026-05-31

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Event

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

Serious Adverse Event

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

Number of Participants with Abnormal Laboratory Parameters Findings

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

HR (bpm)

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

PR (ms)

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

QRS (ms)

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

QT (ms)

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

QTc (ms)

Trial details

NCT IDNCT07551804

SponsorXiamen Amoytop Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Yiming Li, Ph.D

13501936597 yimingli@fudan.edu.cn

View on ClinicalTrials.gov More Adult Growth Hormone Deficiency trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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);

What they're measuring

Adverse Event

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

Serious Adverse Event

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

Number of Participants with Abnormal Laboratory Parameters Findings

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

HR (bpm)

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

PR (ms)

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

QRS (ms)

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

QT (ms)

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

QTc (ms)