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NCT05281328 · ClinicalTrials.gov registry record · Phase 2
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
A Phase 2 study of Polycystic Liver Disease, sponsored by Camurus AB.
- Active
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 11
- Study locations
NCT05281328: Active Phase 2 study of Polycystic Liver Disease, sponsored by Camurus AB.
NCT05281328 is a Phase 2 study of Polycystic Liver Disease that is active but no longer recruiting, run by Camurus AB. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05281328, a Phase 2 study of Polycystic Liver Disease, is active but no longer recruiting, sponsored by Camurus AB.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
Magnetic resonance imaging (MRI) was used to measure the total liver volume (TLV) at baseline and at Week 53 and was adjusted to the participant's height. The change from baseline to Week 53 was calculated as the difference between htTLV values at Week 53 and baseline. The difference in treatment effect between the groups was presented as a ratio expressed in percentage.
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 |
What the registry record for NCT05281328 still lists
NCT05281328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
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.
NCT05281328 lists 11 locations in 6 states (Other, New York, Minnesota).
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.
What interventions are being tested in trial NCT05281328?
The interventions under investigation include: Placebo (DRUG), CAM2029 (DRUG).
Who is sponsoring clinical trial NCT05281328?
This trial is sponsored by Camurus AB, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05281328's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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