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

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.

NCT Number	NCT05281328
Lead Sponsor	Camurus AB
Conditions	Polycystic Liver Disease
Enrollment	71 participants
Start Date	2022-06-28
Primary Completion	2025-02-05 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-01