DRUG
CAM2029
SC injection using a pre-filled pen
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
Status
Active, not recruiting
Phase
Phase 2 / Phase 3
Enrollment
71
Locations
11
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
SC injection using a pre-filled pen
Timeline
From registration to results.
First posted
Mar 16, 2022
Study start
Jun 28, 2022
Primary completion
Feb 5, 2025
Study completion
Aug 2027
Results posted
Jun 1, 2026
Registry updated
Jun 1, 2026
Outcomes
What the study measures.
Primary outcomes
Height-adjusted Total Liver Volume (htTLV)
Time frame · From screening until treatment week 53
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.
Secondary outcomes
PLD Symptom (PLD-S) Score
Time frame · From screening to Week 53
Change from baseline to Week 53 in the PLD-S measure score.
htTLV
Time frame · From screening until treatment weeks 13, 25, 77, 125 and 173
Change from baseline in htTLV as determined by MRI volumetry
PLD-S
Time frame · From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173
Change from baseline in the PLD-S measure score
Height-adjusted Total Kidney Volume (htTKV)
Time frame · From screening until treatment weeks 13, 25, 53, 77, 125 and 173
Change from baseline in htTKV as determined by MRI volumetry
Total Liver Cyst Volume
Time frame · From screening to treatment weeks 13, 25, 53, 77, 125 and 173
Change from baseline in total liver cyst volume determined by MRI volumetry
Estimated Glomerular Filtration Rate (eGFR)
Time frame · From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173
Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C
PLD Impact (PLD-I) Score
Time frame · From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173
Change from baseline in the PLD-I measure score
Clinical Global Impression of Severity (CGI-S) Score
Time frame · From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173
Change from baseline in the CGI-S score
Patient Global Impression of Severity (PGI-S) Score
Time frame · From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173
Change from baseline in the PGI-S score
Patient Global Impression of Change (PGI-C) Score
Time frame · At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173
Change from baseline in the PGI-C score
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
11 registered sites.
Belgium · Germany · Netherlands · United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic
Rochester, Minnesota, United States
Mount Sinai Hospital
New York, New York, United States
The New York Presbyterian Hospital
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Bon Secours Richmond Community Hospital
Richmond, Virginia, United States
University Hospitals KU Leuven
Leuven, Belgium
Hannover Medical School
Hanover, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitaetsklinikum Müenster
Münster, Germany
Radboud UMC, Department of Gastroenterology and Hepatology
Nijmegen, Netherlands
Related trials
More studies on Octreotide.
NCT IDStudyPhase / statusEnrollmentUpdated
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
National Cancer Institute (NCI) · Colorectal Neuroendocrine Tumor G1 · Gastric Neuroendocrine Tumor G1
Phase 3
Active, not recruiting
427
2026-07
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
Camurus AB · Gastro-enteropancreatic Neuroendocrine Tumor
Phase 3
Active, not recruiting
332
2026-07
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Debiopharm International SA · Acromegaly
Phase 3
Recruiting
119
2026-07
Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · ACTH · Cushing's Syndrome
Phase 2
Recruiting
80
2026-07
RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
M.D. Anderson Cancer Center · Neuroendocrine Carcinoma · Islet Cell Carcinoma
Phase 2
Completed
67
2026-07
Effect of Insulin Lowering on Lipogenesis
Columbia University · Hyperinsulinemia · Insulin Resistance
Phase 1
Recruiting
25
2026-07
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Camurus AB · Acromegaly
Not applicable
Recruiting
200
2026-06
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)
Triastek (Shanghai) Limited · Acromegaly
Phase 1
Not yet recruiting
18
2026-06
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.