A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Completed · Phase 3

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT04125836

Run by

Camurus AB

People needed

135

Starts

2019-10-10

Expected to finish

2025-04-24

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%)

Where it is running

• 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
• IRCCS Policlinico San Martino — Genova, Italy
• UCLA Department of Medicine Division of Endocrinology — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.