CIN-102 for Gastroparesis

Recruiting at 86 trial locations

Overseen By David Rausher

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CinDome Pharma, Inc.

Disqualifiers: Non-diabetic gastroparesis, Arrhythmia, Surgery, others

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

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the drug CIN-102 (Deudomperidone) can ease symptoms of diabetic gastroparesis, a condition where the stomach empties too slowly, causing discomfort and other issues. Researchers will compare CIN-102 with a placebo to evaluate its effectiveness and safety for people with this condition. The study seeks participants with diabetes who have experienced gastroparesis symptoms, such as feeling full quickly or nausea, for at least six months. Participants will take the study drug or placebo for 12 weeks and maintain a daily diary of their symptoms. As a Phase 2 trial, this 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 requires participants to stop ongoing treatment for gastroparesis before joining. If you are on a stable dose of GLP-1RA for diabetes, you may continue taking it during the study.

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

Research shows that CIN-102 (deudomperidone) is being tested for safety and effectiveness in treating gastroparesis, a condition that slows stomach emptying. Early results from other studies suggest participants have tolerated this treatment well. Although specific side effect information from this trial is not yet available, CIN-102's progression to the middle stages of testing indicates some promise for safety in earlier research. Ongoing studies continue to examine any side effects and participant reactions to the treatment. ^{1 2 3 4 5}

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

Unlike the standard treatments for gastroparesis, which typically involve drugs like metoclopramide or erythromycin that help stimulate stomach muscles, CIN-102 (Deudomperidone) offers a fresh approach. Researchers are excited about CIN-102 because it appears to work by blocking dopamine receptors, which could help improve stomach motility with potentially fewer side effects. This new mechanism of action is promising because it may provide better symptom relief for patients who haven't responded well to existing options.

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

Research has shown that CIN-102 (deudomperidone), which participants in this trial may receive, might help ease symptoms of diabetic gastroparesis. Early studies suggest it could effectively manage nausea, a common symptom of this condition. Other research indicates that even at high doses, CIN-102 does not harm heart health, a common concern with similar drugs. Although CIN-102 remains under investigation in this trial, these early results offer hope for a helpful treatment for those with gastroparesis. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with diabetic gastroparesis can join this trial. It's not for those allergic to eggs or spirulina, with non-diabetic causes of gastroparesis, using motility agents, or with recent substance abuse issues.

Inclusion Criteria

You have been diagnosed with Gastroparesis

Exclusion Criteria

Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder)

I have not had a botulinum toxin injection in my pylorus in the last 6 months.

Positive drug or alcohol test result at Screening without medical explanation, or a history of alcoholism/substance abuse within 2 years prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1-2 visits (in-person)

Lead-in

Participants complete a Gastric Emptying Breath Test (GEBT) and daily diary to assess eligibility for continued study participation

1 week

1 visit (in-person)

Treatment

Participants receive the study drug or placebo twice daily by mouth and complete daily diaries and other Patient Reported Outcomes (PROs)

12 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CIN-102 (Deudomperidone)

Trial Overview The trial tests CIN-102 (deudomperidone) at two different doses against a placebo to see if it eases diabetic gastroparesis symptoms. Participants will take the study drug orally twice daily for 12 weeks and track their symptoms.

How Is the Trial Designed?

Group I: CIN-102 Dose 1 or 2 Experimental Treatment 1 Intervention

Dose 1 or 2, twice daily for 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo, twice daily for 12 weeks

Who Is Running the Clinical Trial?

CinDome Pharma, Inc.

Lead Sponsor

Trials

4

Recruited

760+

Published Research Related to This Trial

Domperidone is an effective treatment for alleviating nausea and vomiting, particularly in patients receiving cytotoxic drugs and those with chronic postprandial dyspepsia, showing superior efficacy compared to metoclopramide in some studies.

Unlike many other antiemetics, domperidone has a lower risk of causing extrapyramidal side effects, making it a safer option for patients, including children, and those on anti-Parkinsonian medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone. A review of its pharmacological activity, pharmacokinetics and therapeutic efficacy in the symptomatic treatment of chronic dyspepsia and as an antiemetic. Brogden, RN., Carmine, AA., Heel, RC., et al.[2018]

Domperidone is an effective treatment for gastroparesis, but health regulatory agencies have raised concerns about its potential link to an increased risk of sudden cardiac death, particularly at higher doses.

No randomized controlled trials have definitively shown that domperidone increases the risk of sudden cardiac death, but observational studies suggest a possible dose-related risk, indicating that its use in patients undergoing dialysis should be carefully evaluated on an individual basis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone-associated sudden cardiac death in the general population and implications for use in patients undergoing hemodialysis: a literature review. Makari, J., Cameron, K., Battistella, M.[2019]

In a study involving 93 insulin-dependent diabetes patients, both domperidone and metoclopramide were found to be equally effective in alleviating symptoms of diabetic gastroparesis over a 4-week period.

However, domperidone was associated with significantly fewer and less severe central nervous system side effects, such as somnolence and reduced mental acuity, compared to metoclopramide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Patterson, D., Abell, T., Rothstein, R., et al.[2013]

In a study involving 748 patients with gastroparesis, those treated with domperidone (DOM) showed moderate but significant improvements in symptoms, including nausea and fullness, compared to those not receiving DOM.

The analysis highlighted that DOM therapy was particularly effective for younger patients with delayed gastric emptying, suggesting its potential as a beneficial treatment option for certain gastroparesis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Domperidone Therapy on Gastroparesis Symptoms: Results of a Dynamic Cohort Study by NIDDK Gastroparesis Consortium. Sarosiek, I., Van Natta, M., Parkman, HP., et al.[2023]

In a study of 48 patients with gastroparesis, age and specific genetic polymorphisms (notably in the ABCB1 and KCNH2 genes) were linked to the effectiveness of domperidone, suggesting that these factors could help predict patient response to treatment.

Side effects from domperidone were associated with genetic variations in the ADRA1D gene, indicating that pharmacogenetic testing could potentially guide treatment decisions to enhance efficacy and minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone treatment for gastroparesis: demographic and pharmacogenetic characterization of clinical efficacy and side-effects. Parkman, HP., Jacobs, MR., Mishra, A., et al.[2021]

Domperidone is a dopamine-2 receptor antagonist that effectively acts as an antiemetic and prokinetic agent, improving stomach and small intestine motor function without causing neurological side effects due to its limited ability to cross the blood-brain barrier.

It has a strong safety profile for long-term oral use and is now available for prescription in the U.S. for treating gastroparesis and chronic nausea and vomiting, making it a valuable option for gastroenterologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone: review of pharmacology and clinical applications in gastroenterology. Reddymasu, SC., Soykan, I., McCallum, RW.[2022]

Domperidone is effective as a second-line treatment for gastroparesis by enhancing gastric emptying through dopamine-2 receptor inhibition, but it is not FDA-approved in the U.S. due to safety concerns.

The use of domperidone is associated with serious side effects, including risks of sudden cardiac death and ventricular arrhythmia, leading to its controversial status despite its common use in Canada and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dual role of domperidone in gastroparesis and lactation. Phan, H., DeReese, A., Day, AJ., et al.[2014]

In a study of 115 patients with refractory gastroparesis treated with domperidone, 69% reported symptom improvement, particularly in postprandial fullness, nausea, and vomiting, indicating its efficacy in managing these symptoms.

While 12% of patients experienced side effects severe enough to stop treatment, the overall benefits of domperidone for many patients suggest it is a valuable option for managing gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domperidone to Treat Symptoms of Gastroparesis: Benefits and Side Effects from a Large Single-Center Cohort. Schey, R., Saadi, M., Midani, D., et al.[2018]

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. cindome.com cindome.com/wp-content/uploads/DDW_ePoster_final-submitted.pdf

This thorough QT study demonstrated that CIN-102 at ... This thorough QT study demonstrated that CIN-102 at therapeutic and supratherapeutic doses does not have a clinically meaningful effect on ECG parameters, ...

4. 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 ...

5. 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 ...

6. cinrx.com cinrx.com/cindome-pharma-announces-first-patient-dosed-envision-phase-2-clinical-trial-deudomperidone-cin-102-treatment-idiopathic-gastroparesis/

CinDome Pharma Announces First Patient Dosed in the ... The first participant has been dosed in the envision GI Phase 2 clinical trial of deudomperidone (CIN-102) in adults with idiopathic gastroparesis.

7. biospace.com biospace.com/press-releases/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.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/98/NCT04208698/Prot_SAP_001.pdf

CLINICAL STUDY PROTOCOL The safety, PD, and effect of CIN-102 on symptoms of gastroparesis in these patients will also be assessed in this study. The results of this study will be used ...