NCT07551804 Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
| NCT ID | NCT07551804 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xiamen Amoytop Biotech Co., Ltd. |
| Condition | Adult Growth Hormone Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-06-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2026-06-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Yiming Li
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT07551804 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Adult Growth Hormone Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07551804 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07551804 currently recruiting?
Yes, NCT07551804 is actively recruiting participants. Contact the research team at yimingli@fudan.edu.cn for enrollment information.
Where is the NCT07551804 trial being conducted?
This trial is being conducted at Beijing, China, Henan, China, Shanghai, China, Sichuan, China and 2 additional locations.
Who is sponsoring the NCT07551804 clinical trial?
NCT07551804 is sponsored by Xiamen Amoytop Biotech Co., Ltd.. The principal investigator is Yiming Li at Huashan Hospital. The trial plans to enroll 36 participants.