New shot could shrink enlarged livers and ease pain
NCT ID NCT05281328
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called CAM2029 (octreotide) given as a weekly or every-other-week shot to people with symptomatic polycystic liver disease. The goal is to see if it can shrink the liver and reduce symptoms like belly pain, bloating, and nausea. About 71 adults with an enlarged liver will be randomly assigned to receive the drug or a placebo for 53 weeks, with an option to continue on the drug for another 120 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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71 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patient, ≥18 years at screening * Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥1800 mL/m at screening * Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen * Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial Exclusion Criteria: * Surgical intervention for PLD within 3 months before screening * Treatment with a somatostatin analogue (SSA) within 3 months before screening * Non-responsive to previous treatment of PLD with an SSA as per the Investigator's assessment * Systematic cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy * Presence of extrahepatic cysts that, in the Investigator's opinion, may prevent the patient from safely participating in the trial * Severe kidney disease, as defined by eGFR \<30 mL/min/1.73\^m2 * Severe liver disease defined as liver cirrhosis of Child-Pugh class C * Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bon Secours Richmond Community Hospital
Richmond, Virginia, 23602, United States
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Hannover Medical School
Hanover, 30625, Germany
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Radboud UMC, Department of Gastroenterology and Hepatology
Nijmegen, 6525 GA, Netherlands
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The New York Presbyterian Hospital
New York, New York, 10065, United States
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Universitaetsklinikum Müenster
Münster, 48149, Germany
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University Hospitals KU Leuven
Leuven, B-3000, Belgium
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University of Texas Southwestern Medical Center
Dallas, Texas, 75380-8887, United States
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Universitätsklinikum Leipzig
Leipzig, 04103, Germany
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