Trial Outcomes & Findings for A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis (NCT NCT04026997)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

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

Results posted on

2026-03-25

Participant Flow

This study was initiated on 11 September 2019 and completed on 17 December 2020 across 15 clinical sites in the United States (US). A total of 60 participants with idiopathic or diabetic gastroparesis were planned to be enrolled.

A total of 214 subjects with idiopathic or diabetic gastroparesis were screened, of which 142 did not meet the inclusion/exclusion criteria and were screen failed. A total of 72 subjects were randomized in the study.

Participant milestones

Participant milestones
Measure	Cohort 1 - 10 mg BID CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2 - 20 mg QD CIN-102 20 mg tablets by mouth in the morning once daily in the morning plus matching placebo by mouth in the evening for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Placebo (Pooled) CIN-102 matching placebo tablets by mouth twice daily for 14 days (+/- 2 days)
Overall Study STARTED	30	15	9	18
Overall Study COMPLETED	29	15	9	18
Overall Study NOT COMPLETED	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 - 10 mg BID CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2 - 20 mg QD CIN-102 20 mg tablets by mouth in the morning once daily in the morning plus matching placebo by mouth in the evening for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Placebo (Pooled) CIN-102 matching placebo tablets by mouth twice daily for 14 days (+/- 2 days)
Overall Study Randomized in error by the site	1	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1- 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days) CIN-102 Dose 1: CIN-102 Dose 1	Cohort 2- 20 mg QD n=15 Participants CIN-102 20 mg tablets by mouth in the morning and placebo tablets in the evening twice daily for 14 days (+/- 2 days) CIN-102 Dose 2: CIN-102 Dose 2	Cohort 3- 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days) CIN-102 Dose 3: CIN-102 Dose 3	Placebo (Pooled) n=18 Participants Placebo tablets by mouth twice daily for 14 days (+/- 2 days) Placebo: Placebo	Total n=72 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 7.44 • n=138 Participants	58.1 years STANDARD_DEVIATION 7.00 • n=62 Participants	50.7 years STANDARD_DEVIATION 11.91 • n=123 Participants	56.1 years STANDARD_DEVIATION 11.23 • n=158 Participants	57.0 years STANDARD_DEVIATION 9.25 • n=88 Participants
Sex: Female, Male Female	26 Participants n=138 Participants	11 Participants n=62 Participants	8 Participants n=123 Participants	13 Participants n=158 Participants	58 Participants n=88 Participants
Sex: Female, Male Male	4 Participants n=138 Participants	4 Participants n=62 Participants	1 Participants n=123 Participants	5 Participants n=158 Participants	14 Participants n=88 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=138 Participants	9 Participants n=62 Participants	3 Participants n=123 Participants	14 Participants n=158 Participants	45 Participants n=88 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=138 Participants	5 Participants n=62 Participants	6 Participants n=123 Participants	4 Participants n=158 Participants	26 Participants n=88 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=138 Participants	1 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=158 Participants	1 Participants n=88 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=158 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Asian	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=158 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=158 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Black or African American	6 Participants n=138 Participants	3 Participants n=62 Participants	2 Participants n=123 Participants	0 Participants n=158 Participants	11 Participants n=88 Participants
Race (NIH/OMB) White	24 Participants n=138 Participants	12 Participants n=62 Participants	7 Participants n=123 Participants	17 Participants n=158 Participants	60 Participants n=88 Participants
Race (NIH/OMB) More than one race	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=158 Participants	0 Participants n=88 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=138 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	1 Participants n=158 Participants	1 Participants n=88 Participants
Region of Enrollment United States	30 participants n=138 Participants	15 participants n=62 Participants	9 participants n=123 Participants	18 participants n=158 Participants	72 participants n=88 Participants
Gastroparesis type Idiopathic	7 Participants n=138 Participants	5 Participants n=62 Participants	2 Participants n=123 Participants	7 Participants n=158 Participants	21 Participants n=88 Participants
Gastroparesis type Diabetic	23 Participants n=138 Participants	10 Participants n=62 Participants	7 Participants n=123 Participants	11 Participants n=158 Participants	51 Participants n=88 Participants
Baseline GEBT T1/2, n(%) <110 kPCD	11 Participants n=138 Participants	5 Participants n=62 Participants	0 Participants n=123 Participants	7 Participants n=158 Participants	23 Participants n=88 Participants
Baseline GEBT T1/2, n(%) >=110 kPCD	19 Participants n=138 Participants	6 Participants n=62 Participants	2 Participants n=123 Participants	7 Participants n=158 Participants	34 Participants n=88 Participants
Baseline GEBT T1/2, n(%) Not included in analysis due to test lot recall	0 Participants n=138 Participants	4 Participants n=62 Participants	7 Participants n=123 Participants	4 Participants n=158 Participants	15 Participants n=88 Participants
BMI	30.16 kg/m^2 STANDARD_DEVIATION 4.704 • n=138 Participants	29.43 kg/m^2 STANDARD_DEVIATION 6.189 • n=62 Participants	28.89 kg/m^2 STANDARD_DEVIATION 5.859 • n=123 Participants	32.00 kg/m^2 STANDARD_DEVIATION 5.631 • n=158 Participants	30.31 kg/m^2 STANDARD_DEVIATION 5.404 • n=88 Participants

PRIMARY outcome

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

Population: The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=11 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=2 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2) T 1/2 Change from baseline to Day 14	-8.05 Minutes Standard Deviation 35.640	-12.37 Minutes Standard Deviation 17.621	-10.60 Minutes Standard Deviation 37.240	6.20 Minutes	—	—
The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2) T 1/2 Baseline	119 Minutes Standard Deviation 34.654	123.25 Minutes Standard Deviation 34.394	132.97 Minutes Standard Deviation 36.228	138.07 Minutes Standard Deviation 54.684	162.90 Minutes Standard Deviation 12.587	—
The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2) T 1/2 Day 14	111.45 Minutes Standard Deviation 20.923	125.70 Minutes Standard Deviation 44.190	123.16 Minutes Standard Deviation 30.881	197.80 Minutes	—	—

PRIMARY outcome

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

Population: The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed.

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.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=7 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=29 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=1 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)	-1.35 Percent change in GE time Standard Deviation 26.533	-9.27 Percent change in GE time Standard Deviation 11.304	-4.23 Percent change in GE time Standard Deviation 24.278	3.24 Percent change in GE time	—	—

SECONDARY outcome

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

Population: The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed.

The value and change from baseline in GEBT excretion rate (kPCD per minute) were summarized by treatment group. The value and time-matched (to baseline visit) change from baseline of the GEBT results for each post-meal time point were also summarized by treatment group.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=11 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=2 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 150 minutes post meal consumption - Day 14	39.23 kPCD min-1 Standard Deviation 8.021	35.30 kPCD min-1 Standard Deviation 16.488	37.13 kPCD min-1 Standard Deviation 10.002	8.90 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 90 minutes post meal consumption - Day 14	25.10 kPCD min-1 Standard Deviation 6.551	22.01 kPCD min-1 Standard Deviation 10.889	23.60 kPCD min-1 Standard Deviation 6.128	4.20 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 90 minutes post meal consumption - Change from baseline to Day 14	1.55 kPCD min-1 Standard Deviation 10.056	1.96 kPCD min-1 Standard Deviation 5.962	3.37 kPCD min-1 Standard Deviation 9.287	-8.80 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 120 minutes post meal consumption - Baseline	31.45 kPCD min-1 Standard Deviation 12.536	31.04 kPCD min-1 Standard Deviation 12.264	29.02 kPCD min-1 Standard Deviation 11.549	21.453 kPCD min-1 Standard Deviation 25.60	21.50 kPCD min-1 Standard Deviation 7.212	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 180 minutes post meal consumption - Day 14	43.67 kPCD min-1 Standard Deviation 8.078	36.91 kPCD min-1 Standard Deviation 14.398	40.96 kPCD min-1 Standard Deviation 11.080	15.20 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 240 minutes post meal consumption - Change from baseline to Day 14	2.73 kPCD min-1 Standard Deviation 8.144	-3.34 kPCD min-1 Standard Deviation 5.496	-0.79 kPCD min-1 Standard Deviation 11.821	-11.10 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 90 minutes post meal consumption - Baseline	23.55 kPCD min-1 Standard Deviation 10.522	23.30 kPCD min-1 Standard Deviation 9.349	20.53 kPCD min-1 Standard Deviation 9.016	23.10 kPCD min-1 Standard Deviation 12.443	16.75 kPCD min-1 Standard Deviation 10.960	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 120 minutes post meal consumption - Day 14	33.61 kPCD min-1 Standard Deviation 9.146	32.40 kPCD min-1 Standard Deviation 14.678	32.68 kPCD min-1 Standard Deviation 8.901	7.20 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 120 minutes post meal consumption - Change from baseline to Day 14	2.16 kPCD min-1 Standard Deviation 11.547	6.03 kPCD min-1 Standard Deviation 7.958	3.86 kPCD min-1 Standard Deviation 11.008	-6.30 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 45 minutes post meal consumption - Baseline	9.56 kPCD min-1 Standard Deviation 6.040	11.39 kPCD min-1 Standard Deviation 3.680	8.88 kPCD min-1 Standard Deviation 4.113	8.37 kPCD min-1 Standard Deviation 5.132	7.50 kPCD min-1 Standard Deviation 4.950	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 45 minutes post meal consumption - Day 14	10.70 kPCD min-1 Standard Deviation 3.266	10.39 kPCD min-1 Standard Deviation 4.534	10.74 kPCD min-1 Standard Deviation 3.038	4.10 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 45 minutes post meal consumption - Change from Baseline to Day 14	1.14 kPCD min-1 Standard Deviation 6.210	-1.07 kPCD min-1 Standard Deviation 3.475	1.96 kPCD min-1 Standard Deviation 4.091	1.40 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 150 minutes post meal consumption - Baseline	36.89 kPCD min-1 Standard Deviation 11.820	37.94 kPCD min-1 Standard Deviation 13.855	35.97 kPCD min-1 Standard Deviation 12.946	36.33 kPCD min-1 Standard Deviation 23.427	25.90 kPCD min-1 Standard Deviation 0.849	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 150 minutes post meal consumption - Change from baseline to Day 14	2.34 kPCD min-1 Standard Deviation 10.324	2.46 kPCD min-1 Standard Deviation 7.241	1.25 kPCD min-1 Standard Deviation 12.261	-6.80 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 180 minutes post meal consumption - Baseline	40.94 kPCD min-1 Standard Deviation 12.526	40.66 kPCD min-1 Standard Deviation 12.536	39.02 kPCD min-1 Standard Deviation 13.258	38.70 kPCD min-1 Standard Deviation 20.044	30.70 kPCD min-1 Standard Deviation 7.778	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 180 minutes post meal consumption - Change from baseline to Day 14	2.74 kPCD min-1 Standard Deviation 10.959	0.37 kPCD min-1 Standard Deviation 5.949	1.85 kPCD min-1 Standard Deviation 12.445	-5.50 kPCD min-1	—	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 240 minutes post meal consumption - Baseline	41.85 kPCD min-1 Standard Deviation 8.953	42.07 kPCD min-1 Standard Deviation 11.951	41.89 kPCD min-1 Standard Deviation 12.750	40.50 kPCD min-1 Standard Deviation 9.000	29.85 kPCD min-1 Standard Deviation 13.223	—
The Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 240 minutes post meal consumption - Day 14	44.57 kPCD min-1 Standard Deviation 7.928	37.28 kPCD min-1 Standard Deviation 10.679	41.41 kPCD min-1 Standard Deviation 10.422	20.40 kPCD min-1	—	—

SECONDARY outcome

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

Population: The Intent-to-Treat (ITT) Population included all randomized subjects. The Intent-to-Treat (ITT) Population included all randomized subjects. During the course of the study, the GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3 were discovered to be unreliable and were recalled. Consequently, GEBT data for the affected subjects were not analyzed.

The percent change from baseline in GEBT excretion rate (kPCD per minute) was summarized by treatment group. The percent change from baseline of the GEBT results for each post-meal time point was also summarized by treatment group.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=8 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=29 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=1 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 45 minutes post meal consumption - Percent change from Baseline to Day 14	-679.95 Percent change in GEBT excretion rate Standard Deviation 2500.333	-7.99 Percent change in GEBT excretion rate Standard Deviation 28.243	89.31 Percent change in GEBT excretion rate Standard Deviation 266.803	51.85 Percent change in GEBT excretion rate	—	—
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 90 minutes post meal consumption - Percent change from baseline to Day 14	43.43 Percent change in GEBT excretion rate Standard Deviation 117.796	15.73 Percent change in GEBT excretion rate Standard Deviation 41.144	56.73 Percent change in GEBT excretion rate Standard Deviation 125.218	-67.69 Percent change in GEBT excretion rate	—	—
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 120 minutes post meal consumption - Percent change from baseline to Day 14	29.78 Percent change in GEBT excretion rate Standard Deviation 83.476	25.37 Percent change in GEBT excretion rate Standard Deviation 34.722	40.17 Percent change in GEBT excretion rate Standard Deviation 102.994	-46.67 Percent change in GEBT excretion rate	—	—
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 150 minutes post meal consumption - Percent change from baseline to Day 14	21.57 Percent change in GEBT excretion rate Standard Deviation 64.614	7.78 Percent change in GEBT excretion rate Standard Deviation 23.087	23.46 Percent change in GEBT excretion rate Standard Deviation 82.609	-43.31 Percent change in GEBT excretion rate	—	—
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 180 minutes post meal consumption - Percent change from baseline to Day 14	17.80 Percent change in GEBT excretion rate Standard Deviation 46.488	1.40 Percent change in GEBT excretion rate Standard Deviation 15.573	20.31 Percent change in GEBT excretion rate Standard Deviation 65.491	-26.57 Percent change in GEBT excretion rate	—	—
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate GEBT 240 minutes post meal consumption - Percent change from baseline to Day 14	9.87 Percent change in GEBT excretion rate Standard Deviation 25.864	-5.31 Percent change in GEBT excretion rate Standard Deviation 18.076	9.46 Percent change in GEBT excretion rate Standard Deviation 58.567	-35.24 Percent change in GEBT excretion rate	—	—

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) total and subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in ANMS GCSI-DD Total Scores Protocol Scoring Method - Baseline	2.40 score on a scale Standard Deviation 0.464	2.40 score on a scale Standard Deviation 0.530	2.42 score on a scale Standard Deviation 0.666	2.33 score on a scale Standard Deviation 0.276	2.33 score on a scale Standard Deviation 0.583	2.81 score on a scale Standard Deviation 0.594
The Change From Baseline in ANMS GCSI-DD Total Scores Protocol Scoring Method - Day 14	1.23 score on a scale Standard Deviation 0.870	1.08 score on a scale Standard Deviation 0.866	1.40 score on a scale Standard Deviation 0.731	0.83 score on a scale Standard Deviation 0.694	1.78 score on a scale Standard Deviation 1.051	1.33 score on a scale Standard Deviation 0.882
The Change From Baseline in ANMS GCSI-DD Total Scores Manual Scoring Method - Change from baseline to Day 14	-1.11 score on a scale Standard Deviation 0.699	-1.25 score on a scale Standard Deviation 0.831	-0.98 score on a scale Standard Deviation 0.684	-1.38 score on a scale Standard Deviation 0.672	-0.69 score on a scale Standard Deviation 0.736	-1.36 score on a scale Standard Deviation 0.707
The Change From Baseline in ANMS GCSI-DD Total Scores Protocol Scoring Method - Change from baseline to Day 14	-1.18 score on a scale Standard Deviation 0.754	-1.33 score on a scale Standard Deviation 0.864	-1.04 score on a scale Standard Deviation 0.612	-1.50 score on a scale Standard Deviation 0.803	-0.56 score on a scale Standard Deviation 0.665	-1.48 score on a scale Standard Deviation 1.233
The Change From Baseline in ANMS GCSI-DD Total Scores Manual Scoring Method - Baseline	2.15 score on a scale Standard Deviation 0.414	2.13 score on a scale Standard Deviation 0.495	2.14 score on a scale Standard Deviation 0.954	2.18 score on a scale Standard Deviation 0.450	2.16 score on a scale Standard Deviation 0.567	2.56 score on a scale Standard Deviation 0.454
The Change From Baseline in ANMS GCSI-DD Total Scores Manual Scoring Method - Day 14	1.04 score on a scale Standard Deviation 0.833	0.88 score on a scale Standard Deviation 0.671	1.17 score on a scale Standard Deviation 0.582	0.80 score on a scale Standard Deviation 0.730	1.47 score on a scale Standard Deviation 1.082	1.20 score on a scale Standard Deviation 0.693

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) total and subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in ANMS GCSI-DD Total Scores Protocol Scoring Method - Percent change from baseline to Day 14	-49.45 Percent change in score Standard Deviation 33.736	-55.24 Percent change in score Standard Deviation 35.011	-43.64 Percent change in score Standard Deviation 24.813	-63.25 Percent change in score Standard Deviation 34.016	-26.84 Percent change in score Standard Deviation 31.291	-48.79 Percent change in score Standard Deviation 40.507
The Percent Change From Baseline in ANMS GCSI-DD Total Scores Manual Scoring Method - Percent change from baseline to Day 14	-52.61 Percent change in score Standard Deviation 33.887	-55.99 Percent change in score Standard Deviation 35.840	-44.07 Percent change in score Standard Deviation 26.803	-65.05 Percent change in score Standard Deviation 34.164	-35.01 Percent change in score Standard Deviation 36.277	-52.81 Percent change in score Standard Deviation 28.361

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain Manual Scoring Method - Baseline	1.94 score on a scale Standard Deviation 0.841	1.96 score on a scale Standard Deviation 0.872	1.79 score on a scale Standard Deviation 1.160	2.08 score on a scale Standard Deviation 0.833	2.19 score on a scale Standard Deviation 1.042	2.11 score on a scale Standard Deviation 1.171
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain Manual Scoring Method - Day 14	0.73 score on a scale Standard Deviation 0.786	0.87 score on a scale Standard Deviation 0.743	0.97 score on a scale Standard Deviation 0.906	1.00 score on a scale Standard Deviation 1.155	1.33 score on a scale Standard Deviation 1.414	1.33 score on a scale Standard Deviation 1.155
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain Manual Scoring Method - Change from baseline to Day 14	-1.21 score on a scale Standard Deviation 0.981	-1.09 score on a scale Standard Deviation 1.065	-0.80 score on a scale Standard Deviation 1.093	-1.08 score on a scale Standard Deviation 0.957	-0.85 score on a scale Standard Deviation 0.988	-0.78 score on a scale Standard Deviation 0.694

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=26 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=8 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain	-59.74 Percent change in score Standard Deviation 44.230	-41.03 Percent change in score Standard Deviation 79.068	-50.43 Percent change in score Standard Deviation 47.000	-58.33 Percent change in score Standard Deviation 50.000	-43.15 Percent change in score Standard Deviation 45.854	-46.67 Percent change in score Standard Deviation 50.332

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects.

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score Protocol Specified Scoring Method - Baseline	2.82 score on a scale Standard Deviation 0.480	2.87 score on a scale Standard Deviation 0.710	2.80 score on a scale Standard Deviation 0.824	2.58 score on a scale Standard Deviation 0.500	2.70 score on a scale Standard Deviation 0.696	3.11 score on a scale Standard Deviation 1.018
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score Protocol Specified Scoring Method - Day 14	1.45 score on a scale Standard Deviation 0.934	1.47 score on a scale Standard Deviation 1.356	1.76 score on a scale Standard Deviation 1.123	1.00 score on a scale Standard Deviation 0.816	2.33 score on a scale Standard Deviation 1.118	1.67 score on a scale Standard Deviation 1.518
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score Protocol Specified Scoring Method - Change from baseline to Day 14	-1.36 score on a scale Standard Deviation 0.994	-1.40 score on a scale Standard Deviation 1.121	-1.08 score on a scale Standard Deviation 0.785	-1.58 score on a scale Standard Deviation 1.258	-0.37 score on a scale Standard Deviation 0.655	-1.44 score on a scale Standard Deviation 2.219

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects.

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=29 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score	-46.73 Percent change in score Standard Deviation 35.270	-51.82 Percent change in score Standard Deviation 41.422	-41.78 Percent change in score Standard Deviation 32.337	-55.95 Percent change in score Standard Deviation 41.582	-16.16 Percent change in score Standard Deviation 26.339	-33.33 Percent change in score Standard Deviation 76.376

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Protocol Scoring Method - Day 14	0.59 score on a scale Standard Deviation 1.020	0.40 score on a scale Standard Deviation 0.431	0.74 score on a scale Standard Deviation 0.561	0.38 score on a scale Standard Deviation 0.479	1.00 score on a scale Standard Deviation 1.061	0.50 score on a scale Standard Deviation 0.500
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Nausea Day 14	0.82 score on a scale Standard Deviation 0.982	0.73 score on a scale Standard Deviation 0.799	1.34 score on a scale Standard Deviation 1.010	0.75 score on a scale Standard Deviation 0.957	1.67 score on a scale Standard Deviation 1.323	1.00 score on a scale Standard Deviation 1.000
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Protocol Scoring Method - Baseline	1.55 score on a scale Standard Deviation 0.757	1.60 score on a scale Standard Deviation 0.623	1.62 score on a scale Standard Deviation 0.752	1.79 score on a scale Standard Deviation 0.798	1.52 score on a scale Standard Deviation 0.556	2.00 score on a scale Standard Deviation 0.500
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Protocol Scoring Method - Change from baseline to Day 14	-0.95 score on a scale Standard Deviation 0.583	-1.20 score on a scale Standard Deviation 0.812	-0.89 score on a scale Standard Deviation 0.820	-1.42 score on a scale Standard Deviation 0.776	-0.52 score on a scale Standard Deviation 0.719	-1.50 score on a scale Standard Deviation 0.866
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Nausea Baseline	2.45 score on a scale Standard Deviation 0.563	2.67 score on a scale Standard Deviation 0.854	2.52 score on a scale Standard Deviation 0.786	2.33 score on a scale Standard Deviation 0.903	2.59 score on a scale Standard Deviation 0.778	3.00 score on a scale Standard Deviation 0.000
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Nausea Change from baseline to Day 14	-1.64 score on a scale Standard Deviation 0.912	-1.93 score on a scale Standard Deviation 1.476	-1.20 score on a scale Standard Deviation 0.994	-1.58 score on a scale Standard Deviation 0.788	-0.93 score on a scale Standard Deviation 0.997	-2.00 score on a scale Standard Deviation 1.000
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Vomiting Baseline	0.64 score on a scale Standard Deviation 1.206	0.53 score on a scale Standard Deviation 0.764	0.71 score on a scale Standard Deviation 1.020	1.25 score on a scale Standard Deviation 0.918	0.44 score on a scale Standard Deviation 0.577	1.00 score on a scale Standard Deviation 1.000
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Vomiting Day 14	0.36 score on a scale Standard Deviation 1.206	0.07 score on a scale Standard Deviation 0.258	0.14 score on a scale Standard Deviation 0.351	0.00 score on a scale Standard Deviation 0.000	0.33 score on a scale Standard Deviation 1.000	0.00 score on a scale Standard Deviation 0.000
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Vomiting Change from baseline to Day 14	-0.27 score on a scale Standard Deviation 0.467	-0.47 score on a scale Standard Deviation 0.627	-0.59 score on a scale Standard Deviation 0.937	-1.25 score on a scale Standard Deviation 0.918	-0.11 score on a scale Standard Deviation 0.645	-1.00 score on a scale Standard Deviation 1.000

SECONDARY outcome

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

Population: The Intent-to-Treat Population included all randomized subjects

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=29 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Vomiting Percent Change from baseline to Day 14	-80.00 Percent change in score Standard Deviation 44.721	-94.64 Percent change in score Standard Deviation 15.152	-71.73 Percent change in score Standard Deviation 75.756	-100.00 Percent change in score Standard Deviation 0.000	-64.00 Percent change in score Standard Deviation 80.498	-100.00 Percent change in score Standard Deviation 0.000
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Protocol Scoring Method - Percent change from baseline to Day 14	-69.49 Percent change in score Standard Deviation 38.394	-67.94 Percent change in score Standard Deviation 34.799	-52.41 Percent change in score Standard Deviation 37.374	-81.36 Percent change in score Standard Deviation 25.729	-41.08 Percent change in score Standard Deviation 47.221	-72.22 Percent change in score Standard Deviation 25.459
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting Manual Scoring Method - Nausea Percent change from baseline to Day 14	-68.35 Percent change in score Standard Deviation 38.399	38.399 Percent change in score Standard Deviation 42.230	-48.88 Percent change in score Standard Deviation 37.271	-73.96 Percent change in score Standard Deviation 32.342	-41.32 Percent change in score Standard Deviation 43.189	-66.67 Percent change in score Standard Deviation 33.333

SECONDARY outcome

Timeframe: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)

Population: The Intent-to-Treat Population included all randomized subjects.

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) subscale scores and change from baseline for the Intent to Treat Population using the protocol-specified scoring method and manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=30 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Protocol Specified Scoring Method - Baseline	2.85 score on a scale Standard Deviation 0.575	2.74 score on a scale Standard Deviation 0.630	2.84 score on a scale Standard Deviation 0.674	2.63 score on a scale Standard Deviation 0.250	2.78 score on a scale Standard Deviation 0.791	3.33 score on a scale Standard Deviation 0.577
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Protocol Specified Scoring Method - Day 14	1.64 score on a scale Standard Deviation 1.027	1.37 score on a scale Standard Deviation 1.008	1.71 score on a scale Standard Deviation 0.978	1.13 score on a scale Standard Deviation 0.854	2.00 score on a scale Standard Deviation 1.146	1.83 score on a scale Standard Deviation 0.764
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Protocol Specified Scoring Method - Change from baseline to Day 14	-1.21 score on a scale Standard Deviation 0.961	-1.38 score on a scale Standard Deviation 1.011	-1.16 score on a scale Standard Deviation 0.771	-1.50 score on a scale Standard Deviation 1.080	-0.78 score on a scale Standard Deviation 0.816	-1.50 score on a scale Standard Deviation 0.866
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Postprandial fullness Baseline	3.00 score on a scale Standard Deviation 0.471	2.84 score on a scale Standard Deviation 0.795	3.01 score on a scale Standard Deviation 0.634	2.75 score on a scale Standard Deviation 0.167	2.93 score on a scale Standard Deviation 0.760	3.44 score on a scale Standard Deviation 0.509
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Postprandial fullness Day 14	1.73 score on a scale Standard Deviation 1.191	1.53 score on a scale Standard Deviation 1.125	1.79 score on a scale Standard Deviation 1.082	1.25 score on a scale Standard Deviation 0.957	2.22 score on a scale Standard Deviation 1.302	2.00 score on a scale Standard Deviation 1.000
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Postprandial fullness Change from baseline to Day 14	-1.27 score on a scale Standard Deviation 1.114	-1.31 score on a scale Standard Deviation 1.116	-1.24 score on a scale Standard Deviation 0.917	-1.50 score on a scale Standard Deviation 1.106	-0.70 score on a scale Standard Deviation 1.033	-1.44 score on a scale Standard Deviation 1.262
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Early satiety Baseline	2.70 score on a scale Standard Deviation 0.722	2.64 score on a scale Standard Deviation 0.556	2.67 score on a scale Standard Deviation 0.783	2.50 score on a scale Standard Deviation 0.430	2.63 score on a scale Standard Deviation 0.873	3.22 score on a scale Standard Deviation 0.694
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Early satiety Day 14	1.55 score on a scale Standard Deviation 0.934	1.20 score on a scale Standard Deviation 0.941	1.62 score on a scale Standard Deviation 1.015	1.00 score on a scale Standard Deviation 0.816	1.78 score on a scale Standard Deviation 1.093	1.67 score on a scale Standard Deviation 0.577
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Early satiety Change from baseline to Day 14	-1.15 score on a scale Standard Deviation 0.911	-1.44 score on a scale Standard Deviation 0.948	-1.08 score on a scale Standard Deviation 0.834	-1.50 score on a scale Standard Deviation 1.139	-0.85 score on a scale Standard Deviation 0.852	-1.56 score on a scale Standard Deviation 0.509

SECONDARY outcome

Timeframe: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)

Population: The Intent-to-Treat Population included all randomized subjects.

American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary(ANMS GCSI-DD) subscale scores percent change from baseline for the Intent to Treat Population using the protocol-specified scoring method and the manual scoring method. ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD assesses nausea/vomiting, postprandial fullness/early satiety, and bloating on a severity score calculated from a 5-point Likert scale. The ANMS GCSI-DD symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. The negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=11 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=15 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=29 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo n=4 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo n=3 Participants Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Protocol Specified Scoring Method - Percent change from baseline to Day 14	-42.32 Percent change in score Standard Deviation 36.042	-50.14 Percent change in score Standard Deviation 36.594	-41.38 Percent change in score Standard Deviation 29.096	-54.75 Percent change in score Standard Deviation 36.522	-29.47 Percent change in score Standard Deviation 32.944	-44.44 Percent change in score Standard Deviation 25.459
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Postprandial fullness Percent change from baseline to Day 14	-42.90 Percent change in score Standard Deviation 37.929	-45.50 Percent change in score Standard Deviation 38.815	-41.52 Percent change in score Standard Deviation 33.646	-53.13 Percent change in score Standard Deviation 35.904	-26.11 Percent change in score Standard Deviation 38.424	-40.00 Percent change in score Standard Deviation 36.056
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety Manual Scoring Method - Early satiety Percent change from baseline to Day 14	-40.56 Percent change in score Standard Deviation 41.704	-54.88 Percent change in score Standard Deviation 35.651	-40.56 Percent change in score Standard Deviation 31.248	55.95 Percent change in score Standard Deviation 41.582	-30.65 Percent change in score Standard Deviation 38.876	-48.61 Percent change in score Standard Deviation 14.633

SECONDARY outcome

Timeframe: Day 1 (single dose)

Population: PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter.

CMAX is defined as the maximum observed drug concentration after administration.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=12 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=6 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=23 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 1	25.460 ng/mL Standard Deviation 16.8212	6.730 ng/mL Standard Deviation 4.4942	10.066 ng/mL Standard Deviation 5.6474	—	—	—

SECONDARY outcome

Timeframe: Day 14 (steady state)

Population: PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter.

CMAX is defined as the maximum observed drug concentration after administration.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=15 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=27 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 14	36.407 ng/mL Standard Deviation 18.9431	12.276 ng/mL Standard Deviation 10.9355	18.176 ng/mL Standard Deviation 12.0178	—	—	—

SECONDARY outcome

Timeframe: Day 14 (steady state)

Population: PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter.

TMAX is defined as the time to maximum plasma concentration.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=15 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=9 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=27 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 14	2.000 h Interval 1.0 to 6.0	2.000 h Interval 1.0 to 8.0	2.000 h Interval 0.97 to 4.52	—	—	—

SECONDARY outcome

Timeframe: Day 1 (single dose)

Population: PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter.

TMAX is defined as the time to maximum plasma concentration.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=12 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=6 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=23 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 1	2.500 h Interval 1.0 to 6.0	2.000 h Interval 0.98 to 4.05	2.000 h Interval 0.98 to 6.0	—	—	—

SECONDARY outcome

Timeframe: Day 1 (single dose), Time 0 to 12 hours

Population: PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter.

AUC0-12 is defined as the area under the plasma concentration-time curve from pre-dose (Time 0) to 12 Hours on Day 1 of CIN-102 dosing.

Outcome measures

Outcome measures
Measure	Cohort 2 - 20 mg QD n=10 Participants CIN-102 20 mg tablets by mouth in the morning plus placebo tablets in the evening daily for 14 days (+/- 2 days)	Cohort 3 - 5 mg BID n=3 Participants CIN-102 5 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 1 - 10 mg BID n=16 Participants CIN-102 10 mg tablets by mouth twice daily for 14 days (+/- 2 days)	Cohort 2- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo	Cohort 3 - 5 mg BID CIN-102 5 mg tablets by mouth twice daily for 14 days	Cohort 3- Placebo Placebo tablets by mouth twice daily for 14 days Placebo: Placebo
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Area Under the Plasma Concentration-time Curve From Pre-dose (Time 0) to 12 Hours (AUC0-12)	104.33 h*ng/mL Standard Deviation 52.267	34.73 h*ng/mL Standard Deviation 20.907	46.98 h*ng/mL Standard Deviation 22.861	—	—	—

SECONDARY outcome

Timeframe: Day 14 (steady state)

Population: PK Evaluable Population included all subjects who received CIN-102 and had sufficient plasma concentration data to characterize at least 1 PK parameter.

AUCtau is defined as the area under the plasma concentration-time curve over the dosing interval.