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

CinDome Pharma

Status and phase: Enrolling; Phase 2

Conditions: Idiopathic Gastroparesis

Treatments: Drug: Placebo; Drug: CIN-102 Dose 15mg; Drug: CIN-102 Dose 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06899217

CIN-102-124

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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:

  1. Is not taking the agent(s) for the management of diabetes or blood glucose;

  2. 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;

  3. Is tolerating the agent(s) well, according to the Investigator's judgment;

  4. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and

  5. Symptoms of gastroparesis were present before starting the agent(s).

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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], 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;

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 3 patient groups, including a placebo group

CIN-102: 15mg

Experimental group

Description:

15 mg CIN-102, taken orally BID for 12 weeks

Treatment:

Drug: CIN-102 Dose 15mg

CIN-102: 10mg

Experimental group

Description:

10 mg CIN-102, taken orally BID for 12 weeks

Treatment:

Drug: CIN-102 Dose 10mg

Placebo for CIN-102

Placebo Comparator group

Description:

Placebo for CIN-102, taken orally BID for 12 weeks

Treatment:

Drug: Placebo