New weekly shot could help adults with growth hormone deficiency
NCT ID NCT07551804
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This Phase 2a trial tests a new long-acting growth hormone injection called inpegsomatropin in 36 adults with growth hormone deficiency. Participants receive different doses or a placebo once a week to check safety and how well the drug works. The goal is to see if this weekly shot can improve body composition and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inpegsomatropin (a long-acting growth hormone injection)
- What this could lead to
- If successful, this could provide a once-weekly treatment option for adults with growth hormone deficiency, potentially improving body composition and quality of life.
- What could go wrong
- This is an early Phase 2a trial with only 36 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital, Fudan University
RECRUITINGShanghai, China
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Peking University First Hospital
RECRUITINGBeijing, China
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The First Affiliated Hospital of Henan University of Science and Technology
RECRUITINGHenan, China
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The First Affiliated Hospital of Xiamen University
RECRUITINGXiamen, China
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The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGZhejiang, China
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West China Hospital, Sichuan University
RECRUITINGSichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Do adults with childhood growth hormone deficiency keep up with care?
- Weekly shot could replace daily hormone injections for adults
- Could growth hormone ease gulf war illness symptoms?
- Japan study tracks Sogroya's Long-Term safety in severe hormone deficiency
- New growth hormone drug enters first human tests
- New study tracks Sogroya's safety over a decade in growth hormone deficiency