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.
Growth Hormone for the Treatment of Gastroparesis
Status
Recruiting
Phase
Early Phase 1
Enrollment
10
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 31, 2025
Study start
Oct 22, 2024
Primary completion
Oct 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Apr 16, 2026
Outcomes
What the study measures.
Primary outcomes
Gastroparesis Cardinal Symptom Index (GCSI)
Time frame · Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
The Gastroparesis Cardinal Symptom Index (GCSI) is a questionnaire that assesses the severity of gastroparesis symptoms of: nausea, early satiety, postprandial fullness, and upper abdominal pain. Scores range from 0-none to 4-very severe.
Secondary outcomes
Complete Spontaneous Bowel Movements (CSBMs)
Time frame · Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Number of bowel movements, without the aid of laxatives, after which the patient has the sensation of complete defecation.
Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)
Time frame · Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
The Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) scale assess 8 domains: gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloat/flatulence. Scores are scaled so that an average healthy person would score 50 points. A higher score indicates worse gastrointestinal symptoms.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Somapacitan.
NCT IDStudyPhase / statusEnrollmentUpdated
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2026-05
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Not applicable
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.