Recruiting NCT06803589
Growth Hormone for the Treatment of Gastroparesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Growth Hormone.
- Who it may be relevant to
- Registry conditions: Gastroparesis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Low-dose Growth Hormone for the Treatment of Gastroparesis
Overview
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
Interventions
- Drug Growth 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.
Primary outcome measures
- Gastroparesis Cardinal Symptom Index (GCSI) [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks]
Secondary outcome measures (2)
- Complete Spontaneous Bowel Movements (CSBMs) [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks]
- Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS) [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks]
Eligibility criteria
Inclusion criteria
- Symptoms > 6 months that have not responded satisfactorily to standard treatment.
- For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of >21
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mayo Clinic — Phoenix
- Mayo Clinic in Arizona — Scottsdale
Identifiers
NCT: NCT06803589 · 24-003183