Clinical trial NCT06899217: A Study to Evaluate the Efficacy and Safety of CIN-102 (deudomperidone) in Adult Subjects with Idiopathic Gastroparesis.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Idiopathic Gastroparesis
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
Lead sponsor: CinDome Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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


Eligibility criteria: Key Inclusion Criteria:

* Is a male or female ≥18 years of age;
* Has a current diagnosis of gastroparesis defined by the following:

  1. Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
  2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT) at Visit 2.
* Body mass index between 17 and 45 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, may be considered for the study if ALL of the following criteria are satisfied:

  1. Has been on a stable dose of GLP-1RA for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
  2. Is tolerating the GLP-1RA well, according to the Investigator's judgment;
  3. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the GLP-1RA;
  4. Symptoms of gastroparesis were present before starting GLP-1RA therapy; and
  5. Is not taking the GLP-1RA for the management of diabetes or blood glucose control.

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     Key Exclusion Criteria:
* 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 \[eg, Parkinson's disease\]);
* 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;
* 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 enteral tube (e.g. percutaneous endoscopic gastrostomy \[PEG\] or percutaneous endoscopic jejunostomy \[PEJ\] tube) for feeding or decompression;
* Has a substance use disorder or a positive alcohol or positive drug screen.

Primary outcomes:
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.
timeFrame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
Secondary outcomes:
measure: The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
timeFrame: Over the last 2 weeks of the 12-week Treatment Period as compared to Baseline
measure: The percentage of subjects who are identified as responders, defined as an average ≥0.5 reduction from baseline on each of the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
timeFrame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
measure: The percentage of subjects who are identified as responders, defined as achieving ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
timeFrame: Over the last 2 weeks of the 12-week Treatment Period as well as over the entire Treatment Period
measure: The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores.
timeFrame: Over the 12-week Treatment Period
measure: The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
timeFrame: Over the 12-week Treatment Period
measure: 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, and individual subscale scores
timeFrame: Over the 12-week Treatment Period
measure: Change in the Patient Global Impression of Change (PGIC)
timeFrame: Over the 12-week Treatment Period
measure: Change in Patient Global Impression of Severity (PGIS)
timeFrame: From baseline to Week 12
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.
timeFrame: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
measure: The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
timeFrame: Over the final 6 weeks of the 12-week Treatment Period as compared to Baseline
measure: The percentage of subjects who are identified as responders, defined as an average ≥0.5 reduction from baseline on each of the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores
timeFrame: Over the last 6 weeks of the 12-week Treatment Period
measure: The percentage of subjects who are identified as responders, defined as achieving ≥30% reduction from baseline for each of following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
timeFrame: Over the final 6 weeks of the 12-week Treatment Period
measure: The percentage of symptom-free days in the ANMS GCSI-DD Nausea Score, Total Score, Composite of the Nausea and Vomiting Scores, and individual subscale scores.
timeFrame: Over the final 6 weeks of the 12-week Treatment Period
measure: The percentage of symptomatic weeks for each of the following: ANMS GCSI-DD Nausea Score, Total Score, Composite of Nausea and Vomiting Scores, and individual subscale scores
timeFrame: Over the final 6 weeks of the 12-week Treatment Period
measure: 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, and individual subscale scores
timeFrame: Over the final 6 weeks of the 12-week Treatment Period
measure: Change in the Patient Global Impression of Change (PGIC)
timeFrame: Over the final 6 weeks of the 12-week Treatment Period
measure: Change in Patient Global Impression of Severity (PGIS)
timeFrame: Over the final 6 weeks of the 12-week Treatment Period
measure: 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
timeFrame: Over the 12-week Treatment Period
Other outcomes:
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