A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: CIN-102 Dose 1; Drug: CIN-102 Dose 2; Drug: CIN-102 Dose 3

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91910
      • Research Site 101
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Research Site 114
    • Miami, Florida, United States, 33134
      • Research Site 117
    • Miami, Florida, United States, 33183
      • Research Site 118
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site 111
  • Kansas
    • Kansas City, Kansas, United States, 66045
      • Research Site 110
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site 103
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Research Site 112
    • Monroe, Louisiana, United States, 71201
      • Research Site 104
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Research Site 102
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Research Site 121
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Research Site 113
  • New York
    • Great Neck, New York, United States, 11023
      • Research Site 109
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site 120
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Research Site 105
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Research Site 106
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Research Site 119
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Research Site 115
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Research Site 107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients 18 to 70 years old.
• Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.
• Presence of moderate to severe nausea.
• Body mass index (BMI) between 18 and 40 kg/m2, inclusive.
• Glycosylated hemoglobin level <11% at Screening.
• Willing to washout from ongoing treatment for gastroparesis.
• Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

• Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.
• Positive test for drugs of abuse at the screening or evaluation visits.
• Personal or family history of prolonged heart rate-corrected QT.
• History or evidence of clinically significant arrhythmia.
• History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.
• Females who are pregnant, nursing, or planning on becoming pregnant during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; CIN-102 tablets by mouth twice daily for 14 days	Drug: CIN-102 Dose 1; CIN-102 Dose 1
Placebo Comparator: Cohort 1 - Placebo; Placebo tablets by mouth twice daily for 14 days	Drug: Placebo; Placebo
Experimental: Cohort 2; CIN-102 tablets by mouth twice daily for 14 days	Drug: CIN-102 Dose 2; CIN-102 Dose 2
Placebo Comparator: Cohort 2- Placebo; Placebo tablets by mouth twice daily for 14 days	Drug: Placebo; Placebo
Experimental: Cohort 3; CIN-102 tablets by mouth twice daily for 14 days	Drug: CIN-102 Dose 3; CIN-102 Dose 3
Active Comparator: Cohort 3- Placebo; Placebo tablets by mouth twice daily for 14 days	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in gastric emptying	Baseline (gathered on Days -10 to -3) to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in gastric emptying terminal phase elimination half life	Baseline (gathered on Days -10 to -3) to Day 14
The change from baseline in ANMS GCSI-DD total scores	Day -14 to 14
The change from baseline in ANMS GCSI-DD subscale scores	Day -14 to 14

Collaborators and Investigators

• Sponsor: CinDome Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: CIN-102-121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No