CIN-102 for Gastroparesis

Recruiting at 85 trial locations

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CinDome Pharma, Inc.

Must be taking: GLP-1RA

Disqualifiers: Diabetes, Gastric surgery, Obstruction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new treatment, CIN-102, can reduce nausea in individuals with idiopathic gastroparesis, a condition where the stomach empties more slowly than normal. Researchers will compare two doses of CIN-102 to a placebo to identify the most effective option and ensure safety. Individuals experiencing ongoing gastroparesis symptoms without a known cause, such as diabetes, may be suitable for this study. Participants will take the study medication twice daily for 12 weeks and record their symptoms. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a stable dose of a weight loss medication and meet certain criteria, you may continue taking it during the study.

Is there any evidence suggesting that CIN-102 is likely to be safe for humans?

Research has shown that CIN-102, also known as deudomperidone, is under study for its potential to alleviate symptoms of gastroparesis, a condition affecting stomach movement. In earlier studies with patients who have diabetic gastroparesis, the treatment was generally well-tolerated. Some participants experienced mild side effects, but researchers found no major safety concerns.

The current study is in Phase 2, focusing on the safety of CIN-102 for people. Phase 2 trials aim to assess safety and identify any side effects. The progression of CIN-102 to this stage suggests it was tolerable in earlier research phases. While more data will provide a clearer picture, existing studies have not raised significant safety issues with CIN-102. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gastroparesis?

CIN-102 is unique because it offers a new approach to treating gastroparesis by utilizing a different mechanism of action compared to standard medications like metoclopramide or domperidone, which mainly enhance gut motility. CIN-102 is derived from a compound that specifically targets the serotonin receptors in the gut, potentially improving gastric emptying with fewer side effects. Researchers are excited because this targeted action may lead to better symptom relief and improved quality of life for patients without the side effects often associated with current treatments.

What evidence suggests that CIN-102 might be an effective treatment for gastroparesis?

Research shows that CIN-102 (deudomperidone) is under investigation for its potential to reduce symptoms like nausea in people with gastroparesis. Researchers are testing this treatment because it might manage symptoms more effectively than current options. Deudomperidone may work by helping the stomach move food more efficiently, relieving nausea and other discomforts. While information exists on its use in diabetic gastroparesis, this study focuses on idiopathic gastroparesis, where the cause is unknown. Early signs suggest it could be effective, but further results are needed to confirm its benefits. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults with idiopathic gastroparesis, a condition where the stomach empties food slowly without an obvious cause. Participants must have documented delayed gastric emptying, be tolerating GLP-1RA medication well, and have had gastroparesis symptoms for at least 6 months. They should not be taking GLP-1RA for diabetes control.

Inclusion Criteria

I am handling my GLP-1RA medication without major issues.

My tests show slow stomach emptying.

My BMI is between 17 and 45.

Timeline for a Trial Participant

Pre-screening

Participants are initially assessed for potential eligibility

1 visit

Screening & Lead-In

Participants are screened for eligibility to participate in the trial and complete a Gastric Emptying Breath Test (GEBT) and daily diaries

1-2 visits

Lead-In Period

Participants continue with daily diaries and other Patient Reported Outcomes (PROs) to assess eligibility for continued study participation

1 visit

Treatment

Participants receive the study drug or placebo twice daily by mouth for 12 weeks, with daily diaries and other PROs

12 weeks

7 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit

What Are the Treatments Tested in This Trial?

Interventions

• CIN-102

Trial Overview

The trial is testing CIN-102 (deudomperidone) to see if it reduces nausea in adults with idiopathic gastroparesis. It compares two doses of CIN-102 (15mg and 10mg taken twice daily) against a placebo over a period of 12 weeks.

How Is the Trial Designed?

Group I: CIN-102: 15mg Experimental Treatment 1 Intervention

15 mg CIN-102, taken orally BID for 12 weeks

Group II: CIN-102: 10mg Experimental Treatment 1 Intervention

10 mg CIN-102, taken orally BID for 12 weeks

Group III: Placebo for CIN-102 Placebo Group 1 Intervention

Placebo for CIN-102, taken orally BID for 12 weeks

Who Is Running the Clinical Trial?

CinDome Pharma, Inc.

Lead Sponsor

Trials

4

Recruited

760+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05832151

A Study to Evaluate the Efficacy and Safety of CIN-102 ...

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis ...

2.

cinrx.com

cinrx.com/cindome-pharma-announces-enrollment-completion-in-the-envision3d-phase-2-clinical-trial-of-deudomperidone-cin-102-for-the-treatment-of-diabetic-gastroparesis/

CinDome Pharma Announces Enrollment Completion in ...

Deudomperidone represents the first potential therapeutic for the long-term treatment of gastroparesis. Topline data expected in early 2026.

3.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-and-safety-of-cin-102-deudomperidone-in-adult-subjects-with-idiop

A Study to Evaluate the Efficacy and Safety of CIN-102 ...

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic ...

4.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT05832151/

Trial | NCT05832151

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38237696/

The Efficacy of Tradipitant in Patients With Diabetic and ...

Methods: A total of 201 adults with gastroparesis were randomly assigned to oral tradipitant 85 mg (n = 102) or placebo (n = 99) twice daily for 12 weeks.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04026997

A Phase 2 Study of CIN-102 in Adults With Idiopathic and ...

This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with ...