Growth Hormone for the Treatment of Gastroparesis

Low-dose Growth Hormone for the Treatment of Gastroparesis

The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis
• Intervention / Treatment: Drug: Growth Hormone

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Guillermo GI Program Coordinator, Research; Phone Number: 480-301-4679; Email: barahona.guillermo@mayo.edu
• Study Contact Backup: Name: Tisha Lunsford, MD; Email: lunsford.tisha@mayo.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic
      • Contact: Guillermo Barahona Hernandez, Sr. Progam Coordiantor; Phone Number: 480-301-4679
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Guillermo Barahona Hernandez, Program Coordinator, Research, 480-301-4679; Email: barahona.guillermo@mayo.edu
      • Contact: Tisha Lunsford, MD; Phone Number: 480-301-6990; Email: lunsford.tisha@mayo.edu
      • Principal Investigator: Tisha Najet Lunsford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Patients with Gastroparesis	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.; Other Names: Sogroya (Somapacitan-beco injections)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroparesis Cardinal Symptom Index (GCSI)	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Spontaneous Bowel Movements (CSBMs)	Number of bowel movements, without the aid of laxatives, after which the patient has the sensation of complete defecation.	Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)	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.	Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Tisha Lunsford, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroparesis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormones; Pituitary Hormones, Anterior; somapacitan; Growth Hormone
• Other Study ID Numbers: 24-003183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No