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


The purpose of this trial is to assess the long-term safety 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. Anticipate approximately 70 patients enrolled from start in this trial and approximately 70 patients to roll-over from trial NCT04076462.

Full Title of Study: “A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2021


  • Drug: CAM2029 (octreotide subcutaneous depot)
    • Octreotide subcutaneous depot for monthly injections in acromegaly patients

Arms, Groups and Cohorts

  • Experimental: CAM2029 (octreotide subcutaneous depot)
    • CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.

Clinical Trial Outcome Measures

Primary Measures

  • Characterization of adverse events (AEs)
    • Time Frame: Week 0-52

Secondary Measures

  • 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

Participating in This Clinical Trial

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 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%)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Camurus AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Diego Ferone, M.D, Principal Investigator, University of Genova Endocrinology Unit
  • Overall Contact(s)
    • Camurus AB, +46 46 286 57 30, info@camurus.com

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