GastroparesisPhase 2NCT04026997

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

A Phase 2 study testing CIN-102 Dose 1, CIN-102 Dose 2 and CIN-102 Dose 3 in people with Gastroparesis, run by CinDome Pharma, Inc. at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gastroparesis
What is being tested?: CIN-102 Dose 1, CIN-102 Dose 2 and CIN-102 Dose 3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 19 sitesUnited States
Study dates: 11 Sep 2019to 17 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Research Site 111
Atlanta, Georgia, 30322
Research Site 102
Boston, Massachusetts, 02215
Research Site 101
Chula Vista, California, 91910
Research Site 109
Great Neck, New York, 11023
Research Site 107
Jackson, Tennessee, 38305
Research Site 114
Jacksonville, Florida, 32224
Research Site 110
Kansas City, Kansas, 66045
Research Site 113
Las Vegas, Nevada, 89123
Research Site 103
Louisville, Kentucky, 40202
Research Site 112
Marrero, Louisiana, 70072
Research Site 117
Miami, Florida, 33134
Research Site 118
Miami, Florida, 33183
Research Site 104
Monroe, Louisiana, 71201
Research Site 121
Omaha, Nebraska, 68134
Research Site 106
Philadelphia, Pennsylvania, 19140
Research Site 115
Rapid City, South Dakota, 57702
Research Site 119
Summerville, South Carolina, 29485
Research Site 105
Tulsa, Oklahoma, 74104
Research Site 120
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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: Gastroparesis
Being tested: CIN-102 Dose 1, CIN-102 Dose 2, CIN-102 Dose 3, Placebo
Medical subject headings: Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CIN-102 Dose 1Drug
CIN-102 Dose 1
CIN-102 Dose 2Drug
CIN-102 Dose 2
CIN-102 Dose 3Drug
CIN-102 Dose 3
PlaceboDrug
Placebo

Study groups in NCT04026997
Study group	Role	What they receive
Cohort 1	Experimental	CIN-102 tablets by mouth twice daily for 14 days Receives: Drug: CIN-102 Dose 1
Cohort 1 - Placebo	Placebo comparator	Placebo tablets by mouth twice daily for 14 days Receives: Drug: Placebo
Cohort 2	Experimental	CIN-102 tablets by mouth twice daily for 14 days Receives: Drug: CIN-102 Dose 2
Cohort 2- Placebo	Placebo comparator	Placebo tablets by mouth twice daily for 14 days Receives: Drug: Placebo
Cohort 3	Experimental	CIN-102 tablets by mouth twice daily for 14 days Receives: Drug: CIN-102 Dose 3
Cohort 3- Placebo	Active comparator	Placebo tablets by mouth twice daily for 14 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)
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.
Measured: 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)
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.
Measured: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

Secondary outcomes (18)

The Change From Baseline in GE as Measured by the GEBT Excretion Rate
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.
Measured: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate
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.
Measured: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Change From Baseline in ANMS GCSI-DD Total Scores
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Total Scores
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety
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.
Measured: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 1
CMAX is defined as the maximum observed drug concentration after administration.
Measured: Day 1 (single dose)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 14
CMAX is defined as the maximum observed drug concentration after administration.
Measured: Day 14 (steady state)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 14
TMAX is defined as the time to maximum plasma concentration.
Measured: Day 14 (steady state)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 1
TMAX is defined as the time to maximum plasma concentration.
Measured: Day 1 (single dose)
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)
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.
Measured: Day 1 (single dose), Time 0 to 12 hours
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau)
AUCtau is defined as the area under the plasma concentration-time curve over the dosing interval.
Measured: Day 14 (steady state)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201917 Dec 2020

First posted19 Jul 2019
Study start11 Sep 2019
Primary completion17 Dec 2020
Study completion17 Dec 2020

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastroparesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04026997
Sponsor's protocol ID: CIN-102-121
Status last verified: Mar 2026
First submitted: 17 Jul 2019
Last updated: 25 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04026997
Acronym / sponsor ID: CIN-102-121
Conditions: Gastroparesis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated based on Sponsor decision due to lot recall of GEBT kits impacting the primary endpoint evaluation for Dose 2 and Dose 3.
Enrolment: 72 participants (actual)
Lead sponsor: CinDome Pharma, Inc.Industry (pharma, biotech, devices)
Study start: 11 Sep 2019 (actual)
Primary completion: 17 Dec 2020 (actual)
Study completion: 17 Dec 2020 (actual)
First posted: 19 Jul 2019 (actual)
Results: Posted 25 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort 1	Experimental	Drug: CIN-102 Dose 1CIN-102 tablets by mouth twice daily for 14 days
Cohort 1 - Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets by mouth twice daily for 14 days
Cohort 2	Experimental	Drug: CIN-102 Dose 2CIN-102 tablets by mouth twice daily for 14 days
Cohort 2- Placebo	Placebo comparator	Drug: PlaceboPlacebo tablets by mouth twice daily for 14 days
Cohort 3	Experimental	Drug: CIN-102 Dose 3CIN-102 tablets by mouth twice daily for 14 days
Cohort 3- Placebo	Active comparator	Drug: PlaceboPlacebo tablets by mouth twice daily for 14 days

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CIN-102 Dose 1CIN-102 Dose 1	Drug	Cohort 1
CIN-102 Dose 2CIN-102 Dose 2	Drug	Cohort 2
CIN-102 Dose 3CIN-102 Dose 3	Drug	Cohort 3
PlaceboPlacebo	Drug	Cohort 1 - Placebo, Cohort 2- Placebo, Cohort 3- Placebo

Primary outcome

The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)
Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
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.
The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)
Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
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.

18 secondary outcomes

The Change From Baseline in GE as Measured by the GEBT Excretion Rate
Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Percent Change From Baseline in GE as Measured by the GEBT Excretion Rate
Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14
The Change From Baseline in ANMS GCSI-DD Total Scores
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Total Scores
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Upper Abdominal Pain
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Bloating Subscale Score
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Nausea/Vomiting
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14
The Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
The Percent Change From Baseline in ANMS GCSI-DD Subscale Scores - Postprandial Fullness/Early Satiety
Time frame: Baseline (mean score for the 3 days preceding randomization) to Day 14 (+/- 2 days)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 1
Time frame: Day 1 (single dose)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Maximum Observed Concentration (CMAX) - Day 14
Time frame: Day 14 (steady state)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 14
Time frame: Day 14 (steady state)
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Time of Occurrence of CMAX (TMAX) - Day 1
Time frame: Day 1 (single dose)
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)
Time frame: Day 1 (single dose), Time 0 to 12 hours
Pharmacokinetics (PK) Characterization of Multiple Doses of CIN-102: Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau)
Time frame: Day 14 (steady state)

Results and safety

Results posted to the registry on 25 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 - 10 mg BID	30	29
Cohort 2 - 20 mg QD	15	15
Cohort 3 - 5 mg BID	9	9
Placebo (Pooled)	18	18

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

Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14. Mean (Standard Deviation). Unit: Minutes

Measure	Cohort 1 - 10 mg BID n = 30	Cohort 1 - Placebo n = 11	Cohort 2 - 20 mg QD n = 11	Cohort 2- Placebo n = 3	Cohort 3- 5 mg BID n = 2	Cohort 3- Placebo n = 0
T 1/2 Baseline	132.97 (36.228)	119 (34.654)	123.25 (34.394)	138.07 (54.684)	162.90 (12.587)	–
T 1/2 Day 14	123.16 (30.881)	111.45 (20.923)	125.70 (44.190)	197.80	–	–
T 1/2 Change from baseline to Day 14	-10.60 (37.240)	-8.05 (35.640)	-12.37 (17.621)	6.20	–	–

Population analysed: 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.

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

Time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14. Mean (Standard Deviation). Unit: Percent change in GE time

Measure	Cohort 1 - 10 mg BID n = 29	Cohort 1 - Placebo n = 11	Cohort 2 - 20 mg QD n = 7	Cohort 2- Placebo n = 1	Cohort 3- 5 mg BID n = 0	Cohort 3- Placebo n = 0
Value	-4.23 (24.278)	-1.35 (26.533)	-9.27 (11.304)	3.24	–	–

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 16 days (14 days of study drug treatment plus 2 days of follow-up). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1- 10 mg BID	0 of 30 (0%)	7 of 30 (23.3%)	0 of 30
Cohort 2- 20 mg QD	0 of 15 (0%)	6 of 15 (40%)	0 of 15
Cohort 3- 5 mg BID	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Placebo (Pooled)	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18

Limitations and caveats (from the sponsor): Due to the recall of GEBT kits for 11 subjects in Cohort 2 and all subjects in Cohort 3, GEBT data for these subjects were not used, and the study was terminated early by Sponsor decision on 08 January 2021 prior to enrolling the full anticipated Cohort 3 because the primary endpoint was now null.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CIN-102 Dose 1, CIN-102 Dose 2 and CIN-102 Dose 3 in people with Gastroparesis, run by CinDome Pharma, Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2) (time frame: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.