DRUG
CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
Status
Completed
Phase
Phase 3
Enrollment
72
Locations
63
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.
Interventions
Treatment arms and agents.
DRUG
Matching placebo
Matching placebo for CAM2029
Timeline
From registration to results.
First posted
Sep 3, 2019
Study start
Aug 19, 2019
Primary completion
May 2, 2023
Study completion
May 2, 2023
Results posted
Not reported
Registry updated
Apr 25, 2024
Outcomes
What the study measures.
Primary outcomes
Proportion of patients with mean IGF-1 levels ≤1xULN
Time frame · Week 22 and 24
Secondary outcomes
Proportion of patients with mean IGF-1 levels ≤1xULN, including patients with dose reduction
Time frame · Week 22 and 24
Proportion of patients with mean IGF-1 levels ≤1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24
Time frame · Week 22 and 24
Proportion of patients with mean GH levels <2.5 µg/L
Time frame · Week 24
Proportion of patients with mean GH levels <1.0 µg/L
Time frame · Week 24
Incidence of treatment emergent adverse events
Time frame · Week 0 to 24
Proportion of patients/partners declared competent by a healthcare professional to administer intervention
Time frame · Week 0 to 20 and week 24
During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place
Octreotide plasma concentrations over time
Time frame · Week 0 to 24
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patients, ≥18 years at screening * Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed * 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 at screening * Adequate liver, pancreatic, renal and bone marrow functions * Normal ECG Exclusion Criteria: * GH ≥2.5 μg/L at screening (cycle) * 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 * Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)
Study locations
63 registered sites.
Germany · Greece · Hungary · Italy · Poland · Russia · 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
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 Healt Center, 2nd Department of Internal Medicine
Budapest, Hungary
SZTE ÁOK I.sz. Belgyógyászati Klinika
Szeged, Hungary
IRCCS Policlinico San Martino
Genova, Italy
Publications
Results and literature.
PMID 40418492 ↗Glatard A, Friberg-Hietala S, Keutzer L, Hansson A, Johnsson M, Tiberg F. Population Pharmacokinetic Analysis of an Octreotide Depot (CAM2029) in the Treatment of Acromegaly. Clin Pharmacokinet. 2025 Jul;64(7):1079-1092. doi: 10.1007/s40262-025-01522-3. Epub 2025 May 26.PMID 39378125 ↗Ferone D, Freda P, Katznelson L, Gatto F, Kadioglu P, Maffei P, Seufert J, Silverstein JM, Spencer-Segal JL, Isaeva E, Dreval A, Harrie M, Svedberg A, Tiberg F. Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1. J Clin Endocrinol Metab. 2025 May 19;110(6):1729-1739. doi: 10.1210/clinem/dgae707.
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Put the record in context.
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