Recruiting EARLY_PHASE1 Gastroparesis

New treatment option for Gastroparesis

Official title Growth Hormone for the Treatment of Gastroparesis

ClinicalTrials.gov ID: NCT06803589

What this study is testing

What is Growth Hormone?

Growth Hormone is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for gastroparesis.

Also referred to as Sogroya (Somapacitan-beco injections).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this study is to determine whether treatment with Growth Hormone results in symptomatic improvement in patients with gastroparesis.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

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

You likely can't join 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
See the full eligibility criteria
Who can join
  • Symptoms \> 6 months that have not responded satisfactorily to standard treatment.
  • For gastroparesis: Gastroparesis Cardinal Symptom Index (GCSI) score of \>21
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.