A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Polycystic Liver Disease

In brief

The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD). In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment. The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.

Key facts

Study ID: NCT05281328
Run by: Camurus AB
People needed: 71
Starts: 2022-06-28
Expected to finish: 2027-08-01
Last updated by the study team: 2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Mayo Clinic — Rochester, Minnesota, United States
Mount Sinai Hospital — New York, New York, United States
The New York Presbyterian Hospital — New York, New York, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Bon Secours Richmond Community Hospital — Richmond, Virginia, United States
University Hospitals KU Leuven — Leuven, Belgium
Hannover Medical School — Hanover, Germany
Universitätsklinikum Leipzig — Leipzig, Germany
Universitaetsklinikum Müenster — Münster, Germany
Radboud UMC, Department of Gastroenterology and Hepatology — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

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