Clinical Trials

Inclusion Criteria:

1. Male or female subjects ≥18 years of age.

2. Documented carcinoid syndrome requiring medical therapy.

1. Naïve to somatostatin receptor ligands and actively symptomatic or

2. Subjects currently treated with lanreotide, octreotide long acting release, or
short acting octreotide (subcutaneous or oral) who are currently symptomatically
controlled

3. Evaluable documentation of locally advanced or metastatic histopathologically
confirmed well-differentiated neuroendocrine tumor (NET).

4. No significant disease progression as assessed by the Investigator within the last 6
months before initiation of study drug dosing.

Exclusion Criteria:

1. Diarrhea attributed to any condition(s) other than carcinoid syndrome.

2. Uncontrolled/severe diarrhea associated with significant volume contraction,
dehydration, or hypotension.

3. Requires second line treatments (e.g., telotristat) for control of carcinoid syndrome
symptoms.

4. Treatment with tumor-directed therapy <4 weeks before Screening or hepatic
embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor
debulking <12 weeks before Screening.

5. Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma
considered clinically cured, or in situ cervical carcinoma.

Eligibility last updated 8/1/22. Questions regarding updates should be directed to the study team contact.