Gastroparesis, Envision 3D study

Do you have gastroparesis and diabetes?

Consider enrolling in the Envision 3D study, which is researching a study medication that may help.

What is the Envision 3D study?

Envision 3D is researching CIN-102, a study medication called deudomperidone. The Envision 3D study is for people who have gastroparesis with type 1 or type 2 diabetes.

What is the study medication?

The study medication, called CIN-102 or deudomperidone, is a new form of domperidone. Domperidone is used in some countries for symptoms of diabetic gastroparesis as well as stomach-related issues such as nausea and vomiting. Unfortunately, domperidone can have serious side effects, so it is not approved for use in the United States but can be used under a special agreement between a physician and the Food and Drug Administration.

Deudomperidone (CIN-102) is made by slightly changing domperidone. It is expected to have similar benefits with fewer side effects. However, more research is needed.

What can study participants expect?

Participation in the Envision 3D study lasts up to 18 weeks and includes the following steps:

  • Read and sign the Informed Consent Form (ICF).
  • Perform health assessments to confirm if you qualify for the study.
  • Be assigned at random (like the flip of a coin) to receive either the study medication (CIN-102) or placebo (no active ingredients).
  • Take 2 capsules of the study medication or placebo twice per day for 12 weeks Visit the study clinic about 8 times over 12 weeks for frequent health check-ups, medical care, and study health assessments.
  • Visit the study clinic for follow-up health assessments, 1 week after your last dose.

Who can join the study?

You may be eligible to join if you meet the following criteria*:

  • Age 18 or older.
  • Diagnosed with type 1 or type 2 diabetes.
  • Diagnosed with gastroparesis, including gastrointestinal symptoms such as nausea or vomiting after eating, feeling too full after eating, bloating, and/or throat or stomach pain within the last 6 months.
  • *Other criteria apply. Talk to your doctor to learn more.

If you want to know more about it, like What can study participants expect?, you can download the study brochure.