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NCT04125836·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

135

Locations

68

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

CAM2029 (octreotide subcutaneous depot)

Octreotide subcutaneous depot for monthly injections in acromegaly patients

Timeline

From registration to results.

  1. First posted

    Oct 14, 2019

  2. Study start

    Oct 10, 2019

  3. Primary completion

    Apr 24, 2025

  4. Study completion

    Apr 24, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Dec 22, 2025

Outcomes

What the study measures.

Primary outcomes

Characterization of adverse events (AEs)

Time frame · Week 0-52

Secondary outcomes

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

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 * 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

68 registered sites.

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

Related trials

More studies on Octreotide.

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.