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Active, not recruitingNCT05281328POSITANOUpdated Jun 1, 2026Results posted

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

A Phase 2/3 interventional study of CAM2029 and Placebo in Polycystic Liver Disease, sponsored by Camurus AB. Active, not recruiting at 11 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Camurus AB · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Polycystic Liver Disease

Keywords

  • Polycystic liver
  • PLD
  • ADPLD
  • ADPKD
  • PCLD
  • height-adjusted total liver volume
  • htTLV
  • CAM2029
  • POSITANO
03

In context

Polycystic Kidney, Autosomal Dominant

185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.

This study's enrollment of 71 is above the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.

Browse Polycystic Kidney, Autosomal Dominant studies →

Lead sponsor

Camurus AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \<30 mL/min/1.73\^m2
  • Severe liver disease defined as liver cirrhosis of 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    CAM2029 once weekly

    0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly

    Drug: CAM2029

  • Experimental
    CAM2029 once every 2 weeks

    0.5 mL CAM2029 10 mg, SC injection, every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)

    Drug: CAM2029 · Drug: Placebo

  • Placebo comparator
    Placebo

    0.5 mL placebo, SC injection, once weekly

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Height-adjusted Total Liver Volume (htTLV)

    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.

    Time frame: From screening until treatment week 53

Secondary outcomes

  1. PLD Symptom (PLD-S) Score

    Change from baseline to Week 53 in the PLD-S measure score.

    Time frame: From screening to Week 53

  2. htTLV

    Change from baseline in htTLV as determined by MRI volumetry

    Time frame: From screening until treatment weeks 13, 25, 77, 125 and 173

  3. PLD-S

    Change from baseline in the PLD-S measure score

    Time frame: From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173

  4. Height-adjusted Total Kidney Volume (htTKV)

    Change from baseline in htTKV as determined by MRI volumetry

    Time frame: From screening until treatment weeks 13, 25, 53, 77, 125 and 173

  5. Total Liver Cyst Volume

    Change from baseline in total liver cyst volume determined by MRI volumetry

    Time frame: From screening to treatment weeks 13, 25, 53, 77, 125 and 173

  6. Estimated Glomerular Filtration Rate (eGFR)

    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

    Time frame: From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173

  7. PLD Impact (PLD-I) Score

    Change from baseline in the PLD-I measure score

    Time frame: From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

  8. Clinical Global Impression of Severity (CGI-S) Score

    Change from baseline in the CGI-S score

    Time frame: From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173

  9. Patient Global Impression of Severity (PGI-S) Score

    Change from baseline in the PGI-S score

    Time frame: From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

  10. Patient Global Impression of Change (PGI-C) Score

    Change from baseline in the PGI-C score

    Time frame: At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

  11. Short Form-36 (SF-36) Score

    Change from baseline in the SF-36 score

    Time frame: From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173

  12. Polycystic Liver Disease Questionnaire (PLD-Q)

    Change from baseline in the PLD-Q score

    Time frame: From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173

  13. Adverse Events (AEs)

    Incidence of AEs

    Time frame: From screening to the safety follow-up, assessed up to approximately 47 months.

07

Results

Posted Jun 1, 2026

Participant flow

Participant flow — Overall Study
MilestoneCAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlacebo
Started242423
Completed242221
Not completed022
Withdrew: Assigned but not dosed010
Withdrew: Adverse event010
Withdrew: Accessed alternative treatment001
Withdrew: Withdrawal by subject001

Outcome measures

PrimaryHeight-adjusted Total Liver Volume (htTLV)

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.

Time frame:
From screening until treatment week 53
Reported as:
Least squares mean · percentage
Height-adjusted Total Liver Volume (htTLV)
percentageCAM2029Placebo
Height-adjusted Total Liver Volume (htTLV)-0.7 (-2.9 to 1.6)3.9 (0.1 to 7.7)
Statistical analysis
  • CAM2029 vs Placebo · ANCOVA · p = 0.0443 · Estimated relative treatment diff (%): -4.3 · 95% CI -8.4 to -0.1
SecondaryPLD Symptom (PLD-S) Score

Change from baseline to Week 53 in the PLD-S measure score.

Time frame:
From screening to Week 53

Results for this outcome have not been posted.

SecondaryhtTLV

Change from baseline in htTLV as determined by MRI volumetry

Time frame:
From screening until treatment weeks 13, 25, 77, 125 and 173

Results for this outcome have not been posted.

SecondaryPLD-S

Change from baseline in the PLD-S measure score

Time frame:
From screening to weeks 13, 21, 25, 39, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryHeight-adjusted Total Kidney Volume (htTKV)

Change from baseline in htTKV as determined by MRI volumetry

Time frame:
From screening until treatment weeks 13, 25, 53, 77, 125 and 173

Results for this outcome have not been posted.

SecondaryTotal Liver Cyst Volume

Change from baseline in total liver cyst volume determined by MRI volumetry

Time frame:
From screening to treatment weeks 13, 25, 53, 77, 125 and 173

Results for this outcome have not been posted.

SecondaryEstimated Glomerular Filtration Rate (eGFR)

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

Time frame:
From treatment week 1 to weeks 13, 25, 53, 65, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryPLD Impact (PLD-I) Score

Change from baseline in the PLD-I measure score

Time frame:
From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryClinical Global Impression of Severity (CGI-S) Score

Change from baseline in the CGI-S score

Time frame:
From treatment week 1 to weeks 13, 21, 25, 53, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryPatient Global Impression of Severity (PGI-S) Score

Change from baseline in the PGI-S score

Time frame:
From screening to weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryPatient Global Impression of Change (PGI-C) Score

Change from baseline in the PGI-C score

Time frame:
At treatment weeks 13, 21, 25, 39, 53, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryShort Form-36 (SF-36) Score

Change from baseline in the SF-36 score

Time frame:
From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryPolycystic Liver Disease Questionnaire (PLD-Q)

Change from baseline in the PLD-Q score

Time frame:
From treatment week 1 to weeks 25, 53, 77, 101, 125, 149 and 173

Results for this outcome have not been posted.

SecondaryAdverse Events (AEs)

Incidence of AEs

Time frame:
From screening to the safety follow-up, assessed up to approximately 47 months.

Results for this outcome have not been posted.

Adverse events

Collected over From screening to the safety follow-up, assessed up to approximately 43 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CAM2029 Once Weekly0/24 (0%)2/24 (8.3%)24/24 (100%)
CAM2029 Once Every 2 Weeks1/23 (4.3%)3/23 (13%)21/23 (91.3%)
Placebo0/23 (0%)5/23 (21.7%)22/23 (95.7%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventCAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlacebo
Polycystic liver diseaseCongenital, familial and genetic disorders0/241/232/23
GastroenteritisInfections and infestations0/241/230/23
PneumoniaInfections and infestations0/240/231/23
Renal cyst infectionInfections and infestations0/241/230/23
Abdominal painGastrointestinal disorders0/240/231/23
Hepatic cyst rupturedHepatobiliary disorders0/240/231/23
Flank painMusculoskeletal and connective tissue disorders0/240/231/23
Bacterial pyelonephritisInfections and infestations1/240/230/23
Pyelonephritis acuteInfections and infestations1/240/230/23
HydronephrosisRenal and urinary disorders1/240/230/23
Most frequent other events
Showing 10 of 72
Most frequent other events
EventCAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlacebo
DiarrhoeaGastrointestinal disorders18/2414/237/23
Injection site painGeneral disorders11/248/2314/23
Injection site pruritusGeneral disorders12/248/238/23
Abdominal painGastrointestinal disorders10/247/236/23
FlatulenceGastrointestinal disorders3/248/233/23
Injection site erythemaGeneral disorders8/245/231/23
ConstipationGastrointestinal disorders3/243/237/23
Injection site massGeneral disorders6/247/237/23
NauseaGastrointestinal disorders7/245/236/23
HeadacheNervous system disorders7/244/233/23

Baseline characteristics

Age, Continuous
Age, Continuous(years)CAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlaceboTotal
Mean55.9 ± 7.5853.8 ± 8.8952.6 ± 9.9554.1 ± 8.82
Sex: Female, Male
Sex: Female, Male(Participants)CAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlaceboTotal
Female19212161
Male53210
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlaceboTotal
American Indian or Alaska Native0000
Asian1023
Native Hawaiian or Other Pacific Islander0000
Black or African American1012
White22242066
More than one race0000
Unknown or Not Reported0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlaceboTotal
Hispanic or Latino1214
Not Hispanic or Latino23212266
Unknown or Not Reported0101
Height-adjusted total liver volume (htTLV)
Height-adjusted total liver volume (htTLV)(mL/m)CAM2029 Once WeeklyCAM2029 Once Every 2 WeeksPlaceboTotal
Mean3358.25 ± 1485.9023751.61 ± 2157.0863307.39 ± 1416.3703477.34 ± 1713.252
08

Study locations

11 sites
09

References and documents

Publications

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. PubMed 39356039 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05281328
Lead sponsor
Camurus AB
Responsible party
Sponsor
First posted
Mar 16, 2022
Start date
Jun 28, 2022
Primary completion
Feb 5, 2025
Completion
Aug 2027 (estimated)
Results posted
Jun 1, 2026
Last update
Jun 1, 2026

Study contacts

Joost Drenth, MD
principal investigator · Department of Gastroenterology and Hepatology, Radboud UMC Nijmegen, The Netherlands

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029

Other studies in this condition

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Other studies from this sponsor

Camurus AB

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