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

Phase 3

Completed

• Conditions: Acromegaly
• Interventions: Drug: CAM2029 (octreotide subcutaneous depot)

• Registration Number: NCT04125836
• Lead Sponsor: Camurus AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAM2029 (octreotide subcutaneous depot)	CAM2029 (octreotide subcutaneous depot)	CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.

Primary Outcome Measures

Name	Time	Method
Characterization of adverse events (AEs)	Week 0-52

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN	Week 50 to 52
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L	Week 50 to 52
Proportion of patients/partners declared competent by a healthcare professional to administer intervention	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	Week 0-52

Trial Locations

Locations (67)

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

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; 🇺🇸 Saint 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

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