CAM2029 for Polycystic Liver Disease
(POSITANO Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byJoost Drenth, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Camurus AB

Prior Safety Data

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.

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.

See 1 more

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).

See 5 more

Treatment Details

Interventions

CAM2029 (Somatostatin Analogue)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: CAM2029 once weeklyExperimental Treatment1 Intervention

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

Group II: CAM2029 once every 2 weeksExperimental Treatment2 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: PlaceboPlacebo Group1 Intervention

0.5 mL placebo, SC injection, once weekly