A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis
Condition: Diabetic Gastroparesis; Idiopathic Gastroparesis
MeSH terms: Gastroparesis
Intervention: TAK-906 Maleate; Placebo
Intervention description: TAK-906 maleate capsules.; TAK-906 maleate placebo-matching capsules.
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the efficacy and safety of treatment with 2 dose
      levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12
      weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Should have experienced symptoms of gastroparesis (e.g., postprandial fullness,
             nausea, vomiting, upper abdominal pain, and early satiety for at least 3 months before
             screening as assessed by a physician.

          2. Must have confirmed delayed gastric emptying by meeting 1 of the following criteria:

               1. Confirmed by an accepted diagnostic testing method (Gastric Emptying Breath Test
                  [GEBT], scintigraphy, or wireless motility capsule) that is documented in the
                  participant's medical records prior to screening; OR

               2. Participants without previous confirmation of delayed gastric emptying prior to
                  screening will undergo a GEBT after they have stopped taking prohibited
                  medications.

          3. Must have an average composite ANMS GCSI-DD symptom score ≥2 during the 7 days before
             randomization. The predominant symptom experienced by participants must not be
             abdominal pain.

          4. Must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score ≥2 at least 4
             of 7 days or an average nausea subscale symptom score ≥2 during the 7 days before
             randomization. Nausea symptoms must not be attributable to a central disorder (e.g.
             motion sickness, glaucoma, menstrual cycles, migraine headache).

          5. Has a body mass index (BMI) of ≥18 to ≤40 kg/m^2 inclusive.

          6. Participant with diabetes mellitus must have glycosylated hemoglobin (HbA1c) ≤11% at
             screening and before randomization.

          7. Absence of gastric outlet obstruction confirmed by upper GI, computed tomography or
             endoscopy.

        Exclusion Criteria:

          1. Known secondary causes of gastroparesis including but not limited to Parkinson
             disease, cancer, viral illness, or connective tissue diseases.

          2. Predominant gastroparetic symptom is epigastric pain, diffuse abdominal pain, or pain
             associated with bowel movement.

          3. Is taking medications that affect gastric emptying including opioids, glucagon-like
             peptide-1 analogs (e.g., exenatide, liraglutide), amylin analogs (e.g., pramlintide),
             and cannabinoids.

          4. Prior history of gastric surgery, including but not limited to gastrectomy, gastric
             bypass, gastric banding, bariatric surgery, pyloroplasty, vagotomy, or fundoplication,
             which has manipulated the natural anatomy of the stomach.

          5. History of intra-pyloric botulinum toxin injection within 3 months of Screening or
             currently has functioning implantable electric stimulator.

          6. Nasogastric, percutaneous endoscopic gastrostomy, or percutaneous endoscopic
             jejunostomy feeding tube or inpatient hospitalization for gastroparesis within 2 weeks
             before the Screening Visit.

          7. Required parenteral nutrition for treatment of gastroparesis within 2 months before
             the Screening Visit.

          8. Previous diagnosis of gastric bezoar (the presence of retained liquid, bile, or small
             amounts of poorly organized food residue is permitted).

          9. Poor control of diabetes within 30 days prior to randomization, including diabetic
             ketoacidosis, hypoglycemia requiring medical intervention, admission for control of
             diabetes or diabetic complications.

         10. Elevated serum prolactin (>upper limit of normal [ULN]) at Screening.

         11. Has concurrent hypogonadism, current clinically significant menstrual abnormalities,
             such as amenorrhea or oligomenorrhea, or other clinical features of hyperprolactinemia
             such as galactorrhea or gynecomastia.

         12. Has acute or chronic liver disease meeting any of the criteria described below:

               -  Has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total
                  bilirubin >2.0 times the ULN.

               -  Has pre-existing liver cirrhosis that meets Child-Pugh Class B (moderate; total
                  score 7 to 9 points) or C (severe; total score 10 to 15 points) (see Appendix B).

               -  Has acute or chronic hepatitis B or C virus infection, manifesting as one of the
                  following at screening:

               -  Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
                  (HBcAb). NOTE: if a participants tests negative for HBsAg, but positive for
                  HBcAb, the participant would be eligible if the Investigator has documentation of
                  other test results showing that the participant does not have active hepatitis B
                  infection.

               -  Participants with positive hepatitis C antibody (HCV IgG) and quantitative HCV
                  polymerase chain reaction (PCR). HCV PCR is performed only if HCV IgG is
                  positive.

         13. Has renal impairment, defined as a lower limit of (estimated glomerular filtration
             rate [eGFR]) <30 mL/min at screening visit.

         14. Has active neoplastic disease or history of neoplastic disease within 5 years of
             screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma
             in situ of the uterine cervix that has been definitively treated with standard of care
             approaches).

         15. Uncontrolled or poorly controlled medical or psychiatric comorbidities which might
             affect their ability to participate in the study.

         16. Has known COVID-19 infection, or suspected COVID-19 infection (as assessed by the
             investigator).

         17. Signs/symptoms or history of extrapyramidal system disease and other clinically
             relevant CNS or neuropsychiatric disease including but not limited to tardive
             dyskinesia, neuroleptic malignant syndrome, acute dystonia, parkinsonian like
             symptoms, severe mental depression, and history of suicide attempt.