Clinical Trials

Inclusion Criteria:

- Male or female patient, ≥18 years at screening

- Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV
≥1800 mL/m at screening

- Presence of at least 1 of the following PLD-related symptoms within 2 weeks before
screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after
beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side,
abdominal pain, back pain, shortness of breath after physical exertion, limited in
mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen

- Not a candidate for, or not willing to undergo, surgical intervention for hepatic
cysts during the trial

Exclusion Criteria:

- Surgical intervention for PLD within 3 months before screening

- Treatment with a somatostatin analogue (SSA) within 3 months before screening

- Non-responsive to previous treatment of PLD with an SSA as per the Investigator's
assessment

- Systematic cholelithiasis within 3 months before screening or previous medical history
of cholelithiasis induced by SSAs unless treated with cholecystectomy

- Presence of extrahepatic cysts that, in the Investigator's opinion, may prevent the
patient from safely participating in the trial

- Severe kidney disease, as defined by eGFR <30 mL/min/1.73^m2

- Severe liver disease defined as liver cirrhosis of Child-Pugh class C

- Any other current or prior medical condition that may interfere with the conduct of
the trial or the evaluation of its results in the opinion of the Investigator

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

Eligibility last updated 3/28/2024. Questions regarding updates should be directed to the study team contact.