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NCT Number: NCT06803589

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sogroya (Somapacitan-beco injections)

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillermo GI Program Coordinator, Research

CONTACT

[email protected]

480-301-4679

Tisha Lunsford, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Low-dose Growth Hormone for the Treatment of Gastroparesis

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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