A Study to Evaluate the Efficacy and Safety of CIN-102 (deudomperidone) in Adult Subjects with Idiopathic Gastroparesis.

Phase 2

Not yet recruiting

• Conditions: Idiopathic Gastroparesis
• Interventions: Drug: CIN-102 Dose 15mg; Drug: CIN-102 Dose 10mg; Drug: Placebo

• Registration Number: NCT06899217
• Lead Sponsor: CinDome Pharma, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-14
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-03-28
• Primary Completion: 2026-06-23
• Study Completion: 2026-06-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIN-102: 15mg	CIN-102 Dose 15mg	15 mg CIN-102, taken orally BID for 12 weeks
CIN-102: 10mg	CIN-102 Dose 10mg	10 mg CIN-102, taken orally BID for 12 weeks
Placebo for CIN-102	Placebo	Placebo for CIN-102, taken orally BID for 12 weeks

Primary Outcome Measures

Name	Time	Method
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.	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).

Secondary Outcome Measures

Name	Time	Method
The effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline	Over the final 6 weeks of the 12-week Treatment Period 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, and upper Abdominal Pain Score
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	Over the last 6 weeks of the 12-week Treatment Period	• 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, and individual subscale scores
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	Over the final 6 weeks of the 12-week Treatment Period	• 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, and individual subscale scores
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.	Over the final 6 weeks of the 12-week Treatment Period	A symptom-free day is defined as a day with severity of symptoms assessed as "none" \[ie, ANMS GCSI-DD scores of 0\])
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	Over the final 6 weeks of the 12-week Treatment Period	A symptomatic week is defined as average ANMS GCSI-DD score ≥ 2
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	Over the final 6 weeks of the 12-week Treatment Period	Sponsor to provide definition of each severity score
Change in the Patient Global Impression of Change (PGIC)	Over the final 6 weeks of the 12-week Treatment Period	• The change in PGIC over the 12-week Treatment Period
Change in Patient Global Impression of Severity (PGIS)	Over the final 6 weeks of the 12-week Treatment Period	• The change from baseline to Week 12 in PGIS
The effect of CIN-102 to significantly decrease nausea severity as compared to baseline based on the average ANMS GCSI-DD Nausea Subscale Score.	Over the final 6 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).
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	Over the 12-week Treatment Period	* 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