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

NCT04026997 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CIN-102-121
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (2)

• The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

  The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE), after consumption of a standardized 13C-enriched meal. GEBT T1/2 is the time for half of the ingested meal to leave the stomach. It is reported using kPCD, a mathematical expression of a test subject's 13CO2 excretion rate per minute at any measurement time t relative to the dose of 13C contained in the test meal.

  Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

• The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

  The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE), after consumption of a standardized 13C-enriched meal. GEBT T1/2 is the time for half of the ingested meal to leave the stomach. It is reported using kPCD, a mathematical expression of a test subject's 13CO2 excretion rate per minute at any measurement time t relative to the dose of 13C contained in the test meal.

  Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

Secondary Outcomes (18)

• The Change From Baseline in GE as Measured by the GEBT Excretion Rate

  Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

• The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate

  Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

• The Change From Baseline in ANMS GCSI-DD Total Scores

  Baseline (mean score for the 3 days preceding randomization) to Day 14

• The Percent Change From Baseline in ANMS GCSI-DD Total Scores

  Baseline (mean score for the 3 days preceding randomization) to Day 14

• The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain

  Baseline (mean score for the 3 days preceding randomization) to Day 14

Other Outcomes (15)

• The Change From Baseline in PAGI-SYM Total Score

  Baseline (last available assessment prior to the first dose of study drug) to Day 14

• The Percent Change From Baseline in PAGI-SYM Total Score

  Baseline (last available assessment prior to the first dose of study drug) to Day 14

• The Change From Baseline in PAGI-SYM Subscale Score - Heartburn/Regurgitation

  Baseline (last available assessment prior to the first dose of study drug) to Day 14

Study Arms (6)

Cohort 1

EXPERIMENTAL

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 1

Cohort 1 - Placebo

PLACEBO COMPARATOR

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo

Cohort 2

EXPERIMENTAL

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 2

Cohort 2- Placebo

PLACEBO COMPARATOR

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo

Cohort 3

EXPERIMENTAL

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 3

Cohort 3- Placebo

ACTIVE COMPARATOR

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo

Interventions

CIN-102 Dose 1 DRUG

CIN-102 Dose 1

Cohort 1

CIN-102 Dose 2 DRUG

CIN-102 Dose 2

Cohort 2

CIN-102 Dose 3 DRUG

CIN-102 Dose 3

Cohort 3

Placebo DRUG

Placebo

Cohort 1 - Placebo; Cohort 2- Placebo; Cohort 3- Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CinDome Pharma, Inc.: lead

Study Sites (19)

Research Site 101

Chula Vista, California, 91910, United States

Location

Research Site 114

Jacksonville, Florida, 32224, United States

Location

Research Site 117

Miami, Florida, 33134, United States

Location

Research Site 118

Miami, Florida, 33183, United States

Location

Research Site 111

Atlanta, Georgia, 30322, United States

Location

Research Site 110

Kansas City, Kansas, 66045, United States

Location

Research Site 103

Louisville, Kentucky, 40202, United States

Location

Research Site 112

Marrero, Louisiana, 70072, United States

Location

Research Site 104

Monroe, Louisiana, 71201, United States

Location

Research Site 102

Boston, Massachusetts, 02215, United States

Location

Research Site 121

Omaha, Nebraska, 68134, United States

Location

Research Site 113

Las Vegas, Nevada, 89123, United States

Location

Research Site 109

Great Neck, New York, 11023, United States

Location

Research Site 120

Winston-Salem, North Carolina, 27103, United States

Location

Research Site 105

Tulsa, Oklahoma, 74104, United States

Location

Research Site 106

Philadelphia, Pennsylvania, 19140, United States

Location

Research Site 119

Summerville, South Carolina, 29485, United States

Location

Research Site 115

Rapid City, South Dakota, 57702, United States

Location

Research Site 107

Jackson, Tennessee, 38305, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the recall of GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3, GEBT data for these subjects were not used, and the study was terminated early by Sponsor decision on 08 January 2021 prior to enrolling the full anticipated Cohort 3 because the primary endpoint was now null.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: CinDome Pharma, Inc.

info@cinrx.com

844-531-1834

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: September 11, 2019
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Locations

US (19)