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Tests treatment safety and results for Adult Growth Hormone Deficiency
Official title Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
ClinicalTrials.gov ID: NCT07551804
What this study is testing
What is Inpegsomatropin Injection?
Inpegsomatropin Injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for adult growth hormone deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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...
- 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...
- Study participants must agree to use reliable contraceptive measures with their spouses from - Study participants fully understand the purpose...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Henan, China
- Shanghai, China
- Sichuan, China
- Xiamen, China
- Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Henan, China; Shanghai, China; Sichuan, China; Xiamen, China; Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.