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A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
NCT05281328 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG CAM2029
Study Locations (11)
Other
- University Hospitals KU Leuven — Leuven
- Hannover Medical School — Hanover
- Universitätsklinikum Leipzig — Leipzig
- Universitaetsklinikum Müenster — Münster
- Radboud UMC, Department of Gastroenterology and Hepatology — Nijmegen
New York
- Mount Sinai Hospital — New York
- The New York Presbyterian Hospital — New York
Minnesota
- Mayo Clinic — Rochester
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
Texas
- University of Texas Southwestern Medical Center — Dallas
Virginia
- Bon Secours Richmond Community Hospital — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05281328
The ClinicalTrials.gov registry entry for NCT05281328 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Camurus AB, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Polycystic Liver Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05281328 reports 11 study locations spanning 6 distinct geographic areas — top geographies include Other, New York, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05281328 about?
NCT05281328 is a clinical study titled "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...
What is the current status of trial NCT05281328?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2022-06-28. Estimated completion is 2027-08.
What conditions does trial NCT05281328 study?
This clinical trial studies the following conditions: Polycystic Liver Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05281328?
The interventions under investigation include: Placebo (DRUG), CAM2029 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05281328?
This trial is sponsored by Camurus AB, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05281328 being conducted?
This trial has 11 study locations across Minnesota, New York, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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