DRUG
CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Status
Completed
Phase
Phase 3
Enrollment
135
Locations
68
Results
Not posted
Publications
1
Study summary
The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.
Interventions
DRUG
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Timeline
First posted
Oct 14, 2019
Study start
Oct 10, 2019
Primary completion
Apr 24, 2025
Study completion
Apr 24, 2025
Results posted
Not reported
Registry updated
Dec 22, 2025
Outcomes
Characterization of adverse events (AEs)
Time frame · Week 0-52
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN
Time frame · Week 50 to 52
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
Time frame · Week 50 to 52
Proportion of patients/partners declared competent by a healthcare professional to administer intervention
Time frame · Week 0-52
During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place
Octreotide plasma concentrations over time
Time frame · Week 0-52
Eligibility
Inclusion Criteria: * Male or female patients, ≥18 years at screening * Able to provide written informed consent to participate in the trial * Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly * Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening * IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy * Adequate liver, pancreatic, renal and bone marrow functions * Normal ECG Exclusion Criteria: For Roll-over Patients from NCT04076462: * Unresolved, drug-related serious adverse event (SAE) from the preceding trial * Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation For New Patients: * Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\] * Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) * Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated * Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening * Patients who have undergone pituitary surgery within 6 months prior to screening * Patients who have received prior pituitary irradiation within 3 years prior to screening * Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
Study locations
Germany · Greece · Hungary · Italy · Poland · Russia · Serbia · Spain · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
UCLA Department of Medicine Division of Endocrinology
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Prufen Clinical Research LLC
Miami, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis, School of Medicine
St Louis, Missouri, United States
Palm Research Center
Las Vegas, Nevada, United States
Columbia University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Research Institute of Dallas
Dallas, Texas, United States
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
Frankfurt, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
Munich, Germany
Medicover Neuroendokrinologie
Munich, Germany
Medicover Oldenburg MVZ
Oldenburg, Germany
General Hospital of Athens "Laiko", Endocrinology University Clinic
Athens, Greece
Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
Athens, Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, Greece
Military Health Center, 2nd Department of Internal Medicine
Budapest, Hungary
SZTE ÁOK I.sz. Belgyógyászati Klinika
Szeged, Hungary
Publications
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Related PeptideStat pages
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