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Evaluating CIN-102 for treating diabetic gastroparesis in adults

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis

Phase 2 Interventional CinDome Pharma, Inc. · NCT05832151

This study is testing a new medication called CIN-102 to see if it can help adults with diabetic gastroparesis feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment288 (estimated)
Ages18 Years and up
SexAll
SponsorCinDome Pharma, Inc. Industry-sponsored
Locations93 sites (Dothan, Alabama and 92 other locations)
Trial IDNCT05832151 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of CIN-102 (deudomperidone) in adults diagnosed with diabetic gastroparesis. Participants will undergo a screening process followed by a 12-week treatment period where they will receive either the study drug or a placebo. Throughout the trial, patients will complete daily diaries and patient-reported outcomes to monitor their symptoms and overall health. The study will also include a follow-up visit to evaluate the long-term effects of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Type 1 or Type 2 diabetes and documented diabetic gastroparesis.

Not a fit: Patients with a glycosylated hemoglobin (HbA1c) level of 10% or higher or those with other gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate the symptoms of diabetic gastroparesis, improving patients' quality of life.

How similar studies have performed: While there have been studies on treatments for diabetic gastroparesis, the specific use of CIN-102 is a novel approach that has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Is a male or female ≥18 years of age;
* Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;
* Has a current diagnosis of diabetic gastroparesis defined by the following:

  1. Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
  2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.
* Body mass index (BMI) between 18 and 49 kg/m2, inclusive;
* Glycosylated hemoglobin (HbA1c) level \<10% at Screening;
* If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:

  1. The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
  2. Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screening and is anticipated to sustain the same dose during GEBT and throughout the study;
  3. Is tolerating the GLP-1RA well based on Investigator's judgment;
  4. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
  5. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
* Willing to washout from ongoing treatment for gastroparesis.

Key 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);
* Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition;
* History or evidence of clinically significant arrhythmia;
* History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;
* Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;
* Pyloric injection of botulinum toxin within 6 months of Screening;
* Positive test for drugs of abuse;
* Has a known allergy to eggs or spirulina;
* Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Where this trial is running

Dothan, Alabama and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic GastroparesisGastroparesisDiabetic gastroparesisGastrointestinal diseaseDelayed gastric emptyingDigestive system diseasesNauseaVomiting
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.