TerminatedPhase 2

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

Stopped: Terminated based on Sponsor decision due to lot recall of GEBT kits impacting the primary endpoint evaluation for Dose 2 and Dose 3.

United States72 participantsStarted 2019-09-11

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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)

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

Trial details

NCT IDNCT04026997

SponsorCinDome Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-17

Results submitted2023-07-12

View on ClinicalTrials.gov More Gastroparesis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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)

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