Growth Hormone for the Treatment of Gastroparesis

NCT06803589 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 24-003183
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complete Spontaneous Bowel Movements (CSBMs)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

• Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Patients with Gastroparesis

Drug: Growth Hormone

Interventions

Growth Hormone DRUG

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.

Also known as: Sogroya (Somapacitan-beco injections)

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms \> 6 months that have not responded satisfactorily to standard treatment.
• For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Phoenix, Arizona, 85054, United States

RECRUITING

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroparesis

Interventions

Growth Hormone; somapacitan

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tisha Lunsford

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo GI Program Coordinator, Research

CONTACT

480-301-4679; barahona.guillermo@mayo.edu

Tisha Lunsford, MD

CONTACT

lunsford.tisha@mayo.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GI and Hepatology Consultant

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: October 22, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)