CAM2029 for Polycystic Liver Disease

(POSITANO Trial)

Recruiting at 11 trial locations

Overseen By Camurus AB

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Camurus AB

Must not be taking: Somatostatin analogues

Disqualifiers: Severe kidney disease, severe liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 53 weeks

71 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have been treated with a somatostatin analogue (a type of medication) within 3 months before the trial starts.

Research Team

Joost Drenth, MD

Principal Investigator

Department of Gastroenterology and Hepatology, Radboud UMC Nijmegen, The Netherlands

Eligibility Criteria

This trial is for adults over 18 with Polycystic Liver Disease (PLD) who have a liver volume of at least 2500 mL/m and experience symptoms like bloating, abdominal pain, or shortness of breath. Candidates should not be planning surgery for PLD during the trial and must not have severe kidney or liver disease, recent PLD surgery, or non-responsiveness to similar treatments.

Inclusion Criteria

I have experienced symptoms like bloating or abdominal pain recently.

I am 18 years old or older.

I am not planning to have surgery for liver cysts during the trial.

Exclusion Criteria

I have cysts outside my liver that may make it unsafe for me to join the trial.

I have been treated with a somatostatin analogue within the last 3 months.

I have severe liver disease (Child-Pugh class C).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAM2029 or placebo in a randomized, double-blind manner for 53 weeks

53 weeks

Weekly or bi-weekly visits for subcutaneous injections

Open-label extension

Participants may continue receiving CAM2029 treatment for an additional 120 weeks

120 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CAM2029

Trial Overview The study tests CAM2029's effectiveness and safety in treating symptomatic PLD. Participants will randomly receive either CAM2029 weekly or biweekly, or a placebo for 53 weeks. Those completing this phase may enter a 24-week extension receiving only CAM2029 using FluidCrystal technology.

Participant Groups

Group I: CAM2029 once weekly Experimental Treatment 1 Intervention

0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly

Group II: CAM2029 once every 2 weeks Experimental Treatment 2 Interventions

0.5 mL CAM2029 10 mg, SC injection, every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)

Group III: Placebo Placebo Group 1 Intervention

0.5 mL placebo, SC injection, once weekly

Who Is Running the Clinical Trial?

Camurus AB

Lead Sponsor

Trials

9

Recruited

1,900+