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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT04026997

Run by

CinDome Pharma, Inc.

People needed

72

Starts

2019-09-11

Expected to finish

2020-12-17

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Research Site 101 — Chula Vista, California, United States
• Research Site 114 — Jacksonville, Florida, United States
• Research Site 117 — Miami, Florida, United States
• Research Site 118 — Miami, Florida, United States
• Research Site 111 — Atlanta, Georgia, United States
• Research Site 110 — Kansas City, Kansas, United States
• Research Site 103 — Louisville, Kentucky, United States
• Research Site 112 — Marrero, Louisiana, United States
• Research Site 104 — Monroe, Louisiana, United States
• Research Site 102 — Boston, Massachusetts, United States
• Research Site 121 — Omaha, Nebraska, United States
• Research Site 113 — Las Vegas, Nevada, United States
• Research Site 109 — Great Neck, New York, United States
• Research Site 120 — Winston-Salem, North Carolina, United States
• Research Site 105 — Tulsa, Oklahoma, United States
• Research Site 106 — Philadelphia, Pennsylvania, United States
• Research Site 119 — Summerville, South Carolina, United States
• Research Site 115 — Rapid City, South Dakota, United States
• Research Site 107 — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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