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

CinDome Pharma

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Gastroparesis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05832151

CIN-102-123

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 3 patient groups, including a placebo group

CIN-102 Dose 1

Experimental group

Description:

Dose 1 twice daily for 12 weeks

Treatment:

Drug: CIN-102 Dose 1

CIN-102 Dose 2

Experimental group

Description:

Dose 2 twice daily for 12 weeks

Treatment:

Drug: CIN-102 Dose 2

Placebo

Placebo Comparator group

Description:

Placebo twice daily for 12 weeks

Treatment:

Drug: Placebo