RecruitingEarly Phase 1NCT06803589
Growth Hormone for the Treatment of Gastroparesis
Low-dose Growth Hormone for the Treatment of Gastroparesis
Sponsor
Mayo Clinic
Enrollment
10 participants
Start Date
Oct 22, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria2
- Symptoms > 6 months that have not responded satisfactorily to standard treatment.
- For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of >21
Exclusion Criteria13
- Known history of GH deficiency, hypothalamic or pituitary disease
- Diabetes
- Prior use of GH therapy
- Age-adjusted low serum IGF1
- Women on oral estrogen therapy6
- Pregnancy or nursing
- History of malignant solid tumors
- Obesity (BMI > 30)History of coronary and thromboembolic diseases.
- History of sarcoidosis
- History of pituitary surgery
- History of thyroid nodules.
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
- Failure to give informed consent.
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Interventions
DRUGGrowth Hormone
Subjects will receive somapacitan-beco (Sogroya®) administered as a subcutaneous injection once weekly for 12 weeks. All participants will receive a fixed dose of 1.5 mg weekly, regardless of sex.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06803589
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