Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Inclusion Criteria:

• Male or female ≥18 years of age, at the time of Screening.

• Willing and able to comply with the study procedures as specified in the protocol,including at least 70% compliance with the study diary for the 2-week period.

• Documented carcinoid syndrome requiring medical therapy. Participants must exhibitsymptoms of flushing with or without frequent BMs as follows:

• For participants who are naïve/not currently treated with somatostatinreceptors ligands (SRL), they must exhibit an average of >1 flushingepisode/day over a period of 14 days

• For participants who will wash out from SRL treatment, they must exhibit anincrease in daily average flushing episodes and an average of >1 flushingepisode/day over a period of 14 days during the Washout Period.

• Evaluable documentation of locally advanced or metastatic histopathologicallyconfirmed well-differentiated neuroendocrine tumor(s) [NETs].

• No significant disease progression as assessed by the Investigator within the last 6months before randomization.

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 syndromesymptoms in the opinion of the Investigator.

• Treatment with specific NET therapy <4 weeks before Screening (such as everolimus orsunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclidetherapy (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, cancerof the breast or cervix in situ, previously treated malignancy, if all treatment forthat malignancy was completed at least 3 years prior to first dose of studytreatment, and no current evidence of disease, concurrent malignancy determined tobe clinically stable and not requiring treatment.

• Diabetes mellitus treated with insulin for less than 6 weeks prior to the studyentry.

• Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%

• Unable to administer short-acting (SA) octreotide (octreotide acetate injection), orprior nonresponse documented with somatostatin agonists.

• Clinically significant concomitant disease or indicator of disease that is not aresult of the primary disease under study, including but not limited tocardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal [ULN], and/or total bilirubin (TB) >1.5×ULN. (Participants with previously diagnosedGilbert's syndrome not accompanied by other hepatobiliary disorders and associatedwith TB