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

• Status: Recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CinDome Pharma, Inc.

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. Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND

2. Documented delayed gastric emptying within the past 2 years or willing to complete a gastric emptying breath test.

• Body mass index (BMI) between 18 and 45 kg/m2, inclusive;

• Glycosylated hemoglobin (HbA1c) level <10% at Screening;

• 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;

• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.