Evaluating CIN-102 for treating diabetic gastroparesis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• G & L Research, LLC
  Foley, Alabama, United States Recruiting
• Clinical Research Associates, LLC
  Huntsville, Alabama, United States Recruiting
• Onyx Clinical Research
  Phoenix, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting
• Applied Research Center of Arkansas
  Little Rock, Arkansas, United States Recruiting
• Alliance Research Institute - Bell Gardens
  Bell Gardens, California, United States Recruiting

+43 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Rachael Farley
• Email: R.Farley@Medpace.com
• Phone: +1.513.579.9911

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Link between advanced glycation end products and stomach movement problems in diabetic gastroparesis

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• Transplanting washed microbiota to treat diabetic gastroparesis

  This study is testing whether transplanting cleaned gut bacteria can help people with diabetic gastroparesis feel better and improve their quality of life.

  Recruiting The Second Hospital of Nanjing Medical University · Nanjing, Jiangsu · NCT06340217

• Checking pyloric sphincter function in people with gastroparesis symptoms

  We will test whether EndoFLIP, a water‑load satiety test, and a gastric electrical test (Gastric Alimetry) can find pyloric sphincter abnormalities in adults with gastroparesis symptoms compared with people without symptoms.

  Recruiting at 5 sites Johns Hopkins Bloomberg School of Public Health · Scottsdale, Arizona and 4 other locations · NCT04661215

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.