envision 3D Study

What is the envision 3D study?

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

Who can join the envision 3D study?

You may be able to join the study if they meet the following requirements:

• 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
• throat or stomach pain within the last 6 months
• documented delayed gastric emptying within the last 2 years

Other criteria apply. Talk to your doctor to learn more.

What will happen during the study?

For participants: This tool is to help you understand what to expect during the envision 3D study.

1. Review & sign the Informed Consent Form

Read and sign the Informed Consent Form (ICF) before you receive any study assessments.

2. Confirm study
requirements

Visit the study clinic 2 times over < 5 weeks for study assessments to confirm if you qualify for the study. This is called Screening.

3. Be assigned to a study group

Be assigned at random to receive either the study medication (CIN-102) or a placebo (no active ingredients).

4. Take study capsules for 12 weeks

Take 2 capsules of the study medication or placebo twice per day for 12 weeks.

5. Attend study clinic visits

Visit the study clinic 5 visits over 12 weeks for study health assessments.

6. Complete study follow-up

Visit the study clinic 1 more time for final health assessments, 1 week after your last dose.

Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at anytime, for any reason.