NCT05281328

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

A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Symptomatic Polycystic Liver Disease

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Camurus AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Polycystic Liver Disease

Interventions

Type	Name	Description
DRUG	CAM2029	SC injection using a pre-filled pen
DRUG	Placebo	SC injection using a pre-filled pen

Timeline

• Start date: 2022-06-28
• Primary completion: 2025-02-05
• Completion: 2027-08-01
• First posted: 2022-03-16
• Last updated: 2025-12-11

Locations

11 sites across 4 countries: United States, Belgium, Germany, Netherlands

Regulatory

• FDA-regulated drug study