The trial is taking place at:

Adobe Clinical Research, LLC | Tucson, AZ

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A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis


CinDome Pharma

Status and phase

Phase 2


Diabetic Gastroparesis


Drug: Placebo
Drug: CIN-102 Dose 2
Drug: CIN-102 Dose 1

Study type


Funder types




Details and patient eligibility


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 in adult patients.

The main questions it aims to answer are:

  • To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo
  • To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo

Participants will go through the following schedule:

  • Screening period (1-2 visits)

  • Lead-in period (1 visit)

    • Will complete a Gastric Emptying Breath Test (GEBT)
    • Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation
  • 12-week treatment period (5 visits)

    • Study drug taken twice daily by mouth
    • Will complete daily diaries and other PROs as described in protocol
  • 1 week follow-up (1 visit)

Researchers will compare the effects of the following treatments:

  • Drug- CIN-102 Dose 1
  • Drug- CIN-102 Dose 2
  • Drug- Placebo


400 estimated patients




18+ years old


No Healthy Volunteers

Inclusion and 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 45 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. 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;
    2. Is tolerating the GLP-1RA well based on Investigator's judgment;
    3. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
    4. 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);
  • 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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


Quadruple Blind

400 participants in 3 patient groups, including a placebo group

CIN-102 Dose 1
Experimental group
Dose 1 twice daily for 12 weeks
Drug: CIN-102 Dose 1
CIN-102 Dose 2
Experimental group
Dose 2 twice daily for 12 weeks
Drug: CIN-102 Dose 2
Placebo Comparator group
Placebo twice daily for 12 weeks
Drug: Placebo

Trial contacts and locations



Central trial contact

Rachael Farley

Data sourced from

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