Clinical Trials

Inclusion Criteria:

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

2. Documented carcinoid syndrome requiring medical therapy.

1. Not currently treated with somatostatin receptor ligands agonists for at least 12
weeks prior to screening and actively symptomatic. This can include
treatment-naïve subjects.

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 (eg, telotristat) for control of carcinoid syndrome
symptoms.

4. Treatment with specific NET tumor 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.

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

6. Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.