Idiopathic GastroparesisPhase 2NCT06899217
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
A Phase 2 study testing CIN-102 Dose 15mg and CIN-102 Dose 10mg in people with Idiopathic Gastroparesis, run by CinDome Pharma, Inc. at 85 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Gastroparesis
- What is being tested?
- CIN-102 Dose 15mg and CIN-102 Dose 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 85 sitesUnited States
- Study dates
- 29 Jan 2025to 7 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a male or female ≥18 years of age;
- Has a current diagnosis of gastroparesis defined by the following:
- Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
- Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT) at Visit 2.
- Body mass index between 17 and 49 kg/m2, inclusive;
- If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied:
Show all 12Show fewer
- Is not taking the agent(s) for the management of diabetes or blood glucose;
- Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
- Is tolerating the agent(s) well, according to the Investigator's judgment;
- In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
- Symptoms of gastroparesis were present before starting the agent(s).
- -------------------------------------------------------------------------
Who cannot join
- Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders [eg, scleroderma, systemic lupus erythematosus], or other neurologic disorder [eg, Parkinson's disease], postural orthostatic tachycardia syndrome (POTS), etc.]);
- Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
- Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
- Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
- Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
- Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure;
Show all 12Show fewer
- Has a history of gastric surgery;
- Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease;
- Has a history of severe and refractory constipation;
- Has a history or evidence of clinically significant arrhythmia;
- Currently receiving parenteral feeding or presence of a nasogastric or other gastric enteral tube (e.g. percutaneous endoscopic gastrostomy [PEG] or percutaneous endoscopic jejunostomy [PEJ] tube) for feeding or decompression; Note: patients receiving enteral feeding via a jejunostomy tube may be included if, in the opinion of the Investigator, the patient is also taking substantial oral solid intake and are not primarily dependent on enteral nutrition
- Has a substance use disorder or a positive alcohol or positive drug screen.
Trial locations and contacts
85 sites in 1 country.
85 sites in 1 country
United States85 sites
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109
Summit Clinical Research, LLC
Athens, Georgia, 30607
DelRicht Clinical Research - Atlanta
Atlanta, Georgia, 30329
University of Colorado Anschutz
Aurora, Colorado, 80045
Digestive Health - UT Health Austin
Austin, Texas, 78712
Gastro Health - Birmingham
Birmingham, Alabama, 35235
Treasure Valley Medical Research
Boise, Idaho, 83706
Connecticut Clinical Research Institute, LLC
Bristol, Connecticut, 06010
NY Scientific
Brooklyn, New York, 11235
Hope Clinical Research LLC
Canoga Park, California, 91303
American Family Research Group
Cape Coral, Florida, 33909
Westchester Putnam Gastro
Carmel, New York, 10512
Atrium Health - Center for Gastroenterology and Hepatology MMP
Charlotte, North Carolina, 28204
Capital Digestive Care - Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Erick H. Alayo Medical Corporation
Chula Vista, California, 91910
Hometown Urgent Care and Research (Cincinnati)
Cincinnati, Ohio, 45150
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus
Columbus, Ohio, 43228
Flourish Research - Los Angeles (Covina)
Covina, California, 91723
Zenos Clinical Research
Dallas, Texas, 75230
EPIC Medical Research
DeSoto, Texas, 75115
USA and International Research Inc.
Doral, Florida, 33126
Unique Clinical Trials
Doral, Florida, 33172
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, 28304
Aa Mrc, Llc
Flint, Michigan, 48504
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood, Mississippi, 39232
G & L Research, LLC
Foley, Alabama, 36535
Gastro Health - Framingham
Framingham, Massachusetts, 01702
Sanmora Bespoke: Parkway Medical Association
Glen Burnie, Maryland, 21061
Carolina Digestive Diseases & Endoscopy Center
Greenville, North Carolina, 27834
GI Alliance - Gurnee
Gurnee, Illinois, 60031
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
Peters Medical Research
High Point, North Carolina, 27260
Galen Medical Group
Hixson, Tennessee, 37343
Advanced Medical Research Group
Hollywood, Florida, 33021
Amir A Hassan, MD, PA
Houston, Texas, 77089
Pioneer Research Solutions Inc.
Houston, Texas, 77099
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio, 45424
Nature Coast Clinical Research
Inverness, Florida, 34452
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
Rocky Mountain Gastroenterology (RMG)
Lakewood, Colorado, 80228
Gastro Care Institute
Lancaster, California, 93534
Excel Clinical Research
Las Vegas, Nevada, 89109
Digestive Disease Specialists
Las Vegas, Nevada, 89128
Epic Clinical Research
Lewisville, Texas, 75057
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, 72205
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Downtown L.A. Research Center, Inc.
Los Angeles, California, 90017
University of Louisville
Louisville, Kentucky, 40202
Manassas Clinical Research Center
Manassas, Virginia, 20110
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060
Tandem Clinical Research
Marrero, Louisiana, 70072
Allied Biomedical Research Institute, Inc.
Miami, Florida, 33155
Advocate Aurora Health Research Institute
Milwaukee, Wisconsin, 53215
Delta Research Partners of West Monroe, LLC
Monroe, Louisiana, 71201
NOLA Research Works
New Orleans, Louisiana, 70125
Advanced Research Institute Inc
New Port Richey, Florida, 34653
Capital Digestive Center
Norfolk, Virginia, 23502
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas, 76180
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Advanced Research Institute - Ogden
Ogden, Utah, 84405
Quality Clinical Research, Inc
Omaha, Nebraska, 68114
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Portland Gastroenterology Associates
Portland, Maine, 04101
Advanced Research Institute - Portland
Portland, Oregon, 97223
Advanced Research Institute - Reno
Reno, Nevada, 89511
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio, Texas, 78249
Acclaim Clinical Research
San Diego, California, 92120
GI Alliance - Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666
Advanced Research Institute - Sandy
Sandy City, Utah, 84092
The Center for Clinical Trials
Saraland, Alabama, 36571
Frontier Clinical Research, LLC - Smithfield
Smithfield, Pennsylvania, 15478
KAD Clinical Research, LLC
St Louis, Missouri, 63123
GCP Research
St. Petersburg, Florida, 33705
PPCP Division of Gastroenterology
Summerville, South Carolina, 29486
Texas Digestive Specialists
Texas City, Texas, 78550
Kansas Medical Clinic, P.A.
Topeka, Kansas, 66606
Del Sol Research Management, LLC
Tucson, Arizona, 85715
Options Health Research
Tulsa, Oklahoma, 74104
Carle Clinic - Urbana Main
Urbana, Illinois, 61801
St. Charles Clinical Research
Weldon Spring, Missouri, 63304
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, 50265
Focus Clinical Research - West Hills
West Hills, California, 91307
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, 44145
Paradigm Research - Wheatridge
Wheat Ridge, Colorado, 80033
Huron Gastroenterology
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects.
The main questions it aims to answer are:
Read more
- To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
- To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo
Participants will go through the following schedule:
- Pre-screening (1 visit)
- Screening \& Lead-In (1-2 visits)
- Will complete a Gastric Emptying Breath Test (GEBT)
- Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation.
- Lead-In Period (1 visit)
- 12-week treatment period (7 visits)
- Study drug taken twice daily by mouth
- Will complete daily diaries and other PROs as described in protocol
- 1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
- 15 mg CIN-102, taken orally BID for 12 weeks
- 10 mg CIN-102, taken orally BID for 12 weeks
- Placebo for CIN-102, taken orally BID for 12 weeks
- Conditions
- Idiopathic Gastroparesis
- Being tested
- CIN-102 Dose 15mg, Placebo, CIN-102 Dose 10mg
- Keywords
- Gastroparesis, Idiopathic Gastroparesis, Vomiting, Early satiety, Bloating, Epigastric pain, Abdominal pain, Delayed gastric emptying, Dopamine receptor antagonist, Nausea, Post-prandial fullness, Stomach pain, Gastric statis, Dysmotility, Gastric motility
- Medical subject headings
- Gastroparesis, Vomiting, Abdominal Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIN-102 Dose 15mgDrug
Twice daily for 12 weeks
PlaceboDrug
Twice daily for 12 weeks
CIN-102 Dose 10mgDrug
Twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CIN-102: 15mg | Experimental | 15 mg CIN-102, taken orally BID for 12 weeks Receives: Drug: CIN-102 Dose 15mg |
| CIN-102: 10mg | Experimental | 10 mg CIN-102, taken orally BID for 12 weeks Receives: Drug: CIN-102 Dose 10mg |
| Placebo for CIN-102 | Placebo comparator | Placebo for CIN-102, taken orally BID for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).
Measured: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
Secondary outcomes (19)
The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Based on the average ANMS GCSI-DD Total Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and Vomiting Severity Score
Measured: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
- The percentage of subjects achieving an average ≥1 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
Measured: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
- The percentage of subjects achieving an average ≥0.5 point reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
Measured: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores
- Occurrence of subjects achieving an average ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
Measured: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.
A symptom-free day is defined as a day with severity of symptoms assessed as "none" [ie, ANMS GCSI-DD scores of 0])
Measured: Over the 12-week Treatment Period
The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1
Measured: Over the 12-week Treatment Period
The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Sponsor to provide definition of each severity score
Measured: Over the 12-week Treatment Period
The Patient Global Impression of Change (PGIC) value
- The absolute change in PGIC over the 12-week Treatment Period
Measured: Over the 12-week Treatment Period
The Patient Global Impression of Severity (PGIS) value
- The absolute change from baseline to Week 12 in PGIS
Measured: From baseline to Week 12
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).
Measured: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Based on the average ANMS GCSI-DD Total Score, Composite of the Nausea and Vomiting Scores, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, upper Abdominal Pain Score, and vomiting severity scores
Measured: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores
- Occurrence of subjects with an average ≥ 0.5 reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Measured: Over the last 6 weeks of the 12-week Treatment Period
The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores
- Occurrence of subjects achieving a ≥ 30% reduction from baseline, assessed separately for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Measured: Over the final 6 weeks of the 12-week Treatment Period
The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
A symptom-free day is defined as a day with severity of symptoms assessed as "none" [ie, ANMS GCSI-DD scores of 0])
Measured: Over the final 6 weeks of the 12-week Treatment Period
The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
A symptomatic week is defined as average ANMS GCSI-DD score ≥ 1
Measured: Over the final 6 weeks of the 12-week Treatment Period
The percentage of moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Sponsor to provide definition of each severity score
Measured: Over the final 6 weeks of the 12-week Treatment Period
The Patient Global Impression of Change (PGIC) value
- The absolute change in PGIC over the 12-week Treatment Period
Measured: Over the final 6 weeks of the 12-week Treatment Period
The Patient Global Impression of Severity (PGIS) value
- The absolute change from baseline to Week 12 in PGIS
Measured: Over the final 6 weeks of the 12-week Treatment Period
To assess the safety of CIN-102 compared to placebo in adult subjects with idiopathic gastroparesis from the time of informed consent until the EOS
- Incidence of clinically significant changes in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurements, and vital signs, as assessed by the Investigator
- TESAEs
- TEAEs leading to premature discontinuation of study drug
- Treatment-emergent clinically significant laboratory abnormalities
Measured: Over the 12-week Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start29 Jan 2025
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- CinDome Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899217
- Sponsor's protocol ID
- CIN-102-124
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
- ClinicalTrials.gov ID
- NCT06899217
- Acronym / sponsor ID
- CIN-102-124
- Conditions
- Idiopathic Gastroparesis
- Keywords
- Gastroparesis, Idiopathic Gastroparesis, Vomiting, Early satiety, Bloating, Epigastric pain, Abdominal pain, Delayed gastric emptying
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- CinDome Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects.
The main questions it aims to answer are:
- To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
- To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo
Participants will go through the following schedule:
- Pre-screening (1 visit)
- Screening \& Lead-In (1-2 visits)
- Will complete a Gastric Emptying Breath Test (GEBT)
- Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation.
- Lead-In Period (1 visit)
- 12-week treatment period (7 visits)
- Study drug taken twice daily by mouth
- Will complete daily diaries and other PROs as described in protocol
- 1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
- 15 mg CIN-102, taken orally BID for 12 weeks
- 10 mg CIN-102, taken orally BID for 12 weeks
- Placebo for CIN-102, taken orally BID for 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CIN-102: 15mg | Experimental | Drug: CIN-102 Dose 15mg15 mg CIN-102, taken orally BID for 12 weeks |
| CIN-102: 10mg | Experimental | Drug: CIN-102 Dose 10mg10 mg CIN-102, taken orally BID for 12 weeks |
| Placebo for CIN-102 | Placebo comparator | Drug: PlaceboPlacebo for CIN-102, taken orally BID for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Is a male or female ≥18 years of age;
- Has a current diagnosis of gastroparesis defined by the following:
- Body mass index between 17 and 49 kg/m2, inclusive;
- If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied:
- -------------------------------------------------------------------------
Key exclusion criteria (12 listed)
- Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders [eg, scleroderma, systemic lupus erythematosus], or other neurologic disorder [eg, Parkinson's disease], postural orthostatic tachycardia syndrome (POTS), etc.]);
- Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
- Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
- Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
- Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
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 15mgTwice daily for 12 weeks | Drug | CIN-102: 15mg |
| PlaceboTwice daily for 12 weeks | Drug | Placebo for CIN-102 |
| CIN-102 Dose 10mgTwice daily for 12 weeks | Drug | CIN-102: 10mg |
Primary outcome
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
Time frame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).
19 secondary outcomes
The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Time frame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
The percentage of subjects who are identified as responders, defined as archiving an average ≥1 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
Time frame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
The percentage of subjects who are identified as responders, defined as archiving an average ≥0.5 point reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
Time frame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
The percentage of subjects who are identified as responders, defined as achieving an average ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores
Time frame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores.
Time frame: Over the 12-week Treatment Period
The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Time frame: Over the 12-week Treatment Period
The percentage of mild, moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Time frame: Over the 12-week Treatment Period
The Patient Global Impression of Change (PGIC) value
Time frame: Over the 12-week Treatment Period
The Patient Global Impression of Severity (PGIS) value
Time frame: From baseline to Week 12
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.
Time frame: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Time frame: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
The percentage of subjects identified as responders, defined as an average ≥0.5 reduction from baseline on each of ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores
Time frame: Over the last 6 weeks of the 12-week Treatment Period
The percentage of subjects identified as responders, defined as achieving ≥30% reduction from baseline for each: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, vomiting severity scores
Time frame: Over the final 6 weeks of the 12-week Treatment Period
The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Time frame: Over the final 6 weeks of the 12-week Treatment Period
The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Time frame: Over the final 6 weeks of the 12-week Treatment Period
The percentage of moderate, severe and very severe symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, individual subscale scores, and vomiting severity scores
Time frame: Over the final 6 weeks of the 12-week Treatment Period
The Patient Global Impression of Change (PGIC) value
Time frame: Over the final 6 weeks of the 12-week Treatment Period
The Patient Global Impression of Severity (PGIS) value
Time frame: Over the final 6 weeks of the 12-week Treatment Period
To assess the safety of CIN-102 compared to placebo in adult subjects with idiopathic gastroparesis from the time of informed consent until the EOS
Time frame: Over the 12-week Treatment Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
85 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 15mg and CIN-102 Dose 10mg in people with Idiopathic Gastroparesis, run by CinDome Pharma, Inc. at 85 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score. (time frame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.