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

CinDome Pharma

Status and phase: Completed; Phase 2

Conditions: Gastroparesis

Treatments: Drug: CIN-102 Dose 3; Drug: Placebo; Drug: CIN-102 Dose 2; Drug: CIN-102 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04026997

CIN-102-121

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

73 participants in 6 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

CIN-102 tablets by mouth twice daily for 14 days

Treatment:

Drug: CIN-102 Dose 1

Cohort 1 - Placebo

Placebo Comparator group

Description:

Placebo tablets by mouth twice daily for 14 days

Treatment:

Drug: Placebo

Cohort 2

Experimental group

Description:

CIN-102 tablets by mouth twice daily for 14 days

Treatment:

Drug: CIN-102 Dose 2

Cohort 2- Placebo

Placebo Comparator group

Description:

Placebo tablets by mouth twice daily for 14 days

Treatment:

Drug: Placebo

Cohort 3

Experimental group

Description:

CIN-102 tablets by mouth twice daily for 14 days

Treatment:

Drug: CIN-102 Dose 3

Cohort 3- Placebo

Active Comparator group

Description:

Placebo tablets by mouth twice daily for 14 days

Treatment:

Drug: Placebo