Recruiting
Early Phase 1

Growth Hormone

Sponsor:

Mayo Clinic

Code:

NCT06803589

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Growth Hormone

Study Details

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

Study ID

NCT06803589

Start date

Oct 22, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Patients with Gastroparesis

Interventions

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 measure

  • Gastroparesis Cardinal Symptom Index (GCSI) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks ]

Central Contacts and Locations

Central contacts

Guillermo GI Program Coordinator, Research

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

Tisha Lunsford, MD

lunsford.tisha@mayo.edu

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Guillermo Barahona Hernandez, Sr. Progam Coordiantor

480-301-4679

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Guillermo Barahona Hernandez, Program Coordinator, Research, 480-301-4679

barahona.guillermo@mayo.edu

Tisha Lunsford, MD

480-301-6990lunsford.tisha@mayo.edu

Principal Investigator:

Tisha Najet Lunsford

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-16.