A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

  • days left to enroll
  • participants needed
  • sponsor
    Camurus AB
Updated on 7 October 2022
somatomedin c
hepatic disease
insulin-like growth factor


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.

Condition Acromegaly
Treatment Matching Placebo, CAM2029 (octreotide subcutaneous depot)
Clinical Study IdentifierNCT04076462
SponsorCamurus AB
Last Modified on7 October 2022


Yes No Not Sure

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%)
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