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

Study acronym: POSITANO
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorCamurus AB
Started
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Record History

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  1. Results first posted: Jun 1, 2026v15
  2. Re-verified, no change to tracked fieldsv14
  3. Secondary endpoints revised (13)
    • Primary endpoint revised
    • Site details revised at 1 of 11 sites
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary completion date changed from estimate of Feb 2025 to Feb 5, 2025v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study completion date: Aug 2025 to Aug 2027
    • Secondary endpoints: 12 to 13
    v10
  2. Trial status: Recruiting to Active, Not Recruitingv9 Show 4 more changesShow less
    • Enrollment target: estimated 69 to confirmed 71
    • Study sites: 12 to 11
    • Primary completion date: Dec 2024 to Feb 2025
    • Study completion date: Jun 2025 to Aug 2025
  3. Study sites: 9 to 12v8
  4. Primary completion date: Jan 2024 to Dec 2024
    • Study sites: 7 to 9
    • Study completion date: Aug 2024 to Jun 2025
    • Eligibility criteria expanded, about 1 word
    v7
  5. Study sites: 5 to 7v6
  6. Study sites: 2 to 5v5
  7. Site contacts updated at 1 of 2 sitesv4
  8. Start date changed from estimate of Jun 2022 to Jun 28, 2022v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 2022 to Jun 2022
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Camurus AB
4 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT05281328
Lead Sponsor Camurus AB
Conditions
(from sponsor)		 Polycystic Liver Disease
Related terms Polycystic Kidney, Autosomal Dominant, Polycystic liver disease
Enrollment 71 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov