GastroparesisEarly Phase 1NCT06803589
Growth Hormone for the Treatment of Gastroparesis
A Early Phase 1 study testing Growth Hormone in people with Gastroparesis, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Growth Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2024to Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms > 6 months that have not responded satisfactorily to standard treatment.
- For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of >21
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tisha Lunsford, MD contact
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Guillermo Barahona Hernandez, Sr. Progam Coordiantor, 480-301-4679
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Guillermo Barahona Hernandez, Program Coordinator, Research, 480-301-4679, barahona.guillermo@mayo.edu
Tisha Lunsford, MD, 480-301-6990, lunsford.tisha@mayo.edu
About this study
Official title: 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.
- Conditions
- Gastroparesis
- Being tested
- Growth Hormone
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
Also called Sogroya (Somapacitan-beco injections)
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients with Gastroparesis Receives: Drug: Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Secondary outcomes (2)
Complete Spontaneous Bowel Movements (CSBMs)
Number of bowel movements, without the aid of laxatives, after which the patient has the sensation of complete defecation.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start22 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tisha N. Lunsford, Mayo Clinic
- Investigators
- Tisha Lunsford, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803589
- Sponsor's protocol ID
- 24-003183
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Growth Hormone for the Treatment of Gastroparesis
- ClinicalTrials.gov ID
- NCT06803589
- Acronym / sponsor ID
- 24-003183
- Conditions
- Gastroparesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Growth HormonePatients with Gastroparesis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptoms > 6 months that have not responded satisfactorily to standard treatment.
- For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of >21
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth HormoneAlso: Sogroya (Somapacitan-beco injections)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. | Drug | Treatment Group |
Primary outcome
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.
2 secondary outcomes
Complete Spontaneous Bowel Movements (CSBMs)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Gastrointestinal Patient Reported Outcomes Measurement Information System (GI- PROMIS)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tisha Lunsford, MD contact
Tisha Lunsford principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Growth Hormone in people with Gastroparesis, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo GI Program Coordinator, Research (480-301-4679, barahona.guillermo@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroparesis Cardinal Symptom Index (GCSI) (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.