Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Exclusion Criteria

• •Diarrhea attributed to any condition(s) other than carcinoid syndrome.
• •Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
• •Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
• •Treatment with specific NET therapy \<4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking \<12 weeks before Screening.
• •Major surgery within 8 weeks before Screening.
• •History of another primary malignancy \<3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast or cervix in situ, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment.
• •Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
• •Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
• •Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
• •Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal \[ULN\], and/or total bilirubin (TB) \>1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB