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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: CIN-102 Dose 1
* Drug: CIN-102 Dose 2
* Drug: CIN-102 Dose 3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |