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

Description

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 (7 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 15 mg or 10 mg * Drug- Placebo

Conditions

Diabetic Gastroparesis

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Study Overview

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Study Details

Study overview

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 (7 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 15 mg or 10 mg * Drug- Placebo

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

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

Condition
Diabetic Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Dothan

Digestive Health Specialists of the Southeast, Dothan, Alabama, United States, 36305

Foley

G & L Research, LLC, Foley, Alabama, United States, 36535

Huntsville

Clinical Research Associates, LLC, Huntsville, Alabama, United States, 35801

Peoria

Phoenix Medical Research Institute, LLC, Peoria, Arizona, United States, 85381

Phoenix

Onyx Clinical Research, Phoenix, Arizona, United States, 85381

Tucson

Del Sol Research Management, LLC, Tucson, Arizona, United States, 85715

Little Rock

Preferred Research Partners, Inc., Little Rock, Arkansas, United States, 72211

Little Rock

Applied Research Center of Arkansas, Little Rock, Arkansas, United States, 72212

North Little Rock

Arkansas Gastroenterology - North Little Rock, North Little Rock, Arkansas, United States, 72117

Bell Gardens

Alliance Research Institute - Bell Gardens, Bell Gardens, California, United States, 90201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CinDome Pharma, Inc.,

Study Record Dates

2025-09-30