A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

HS-18-633

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.

2019-08-19

2023-05-02

2023-05-02

Completed

Early phase I

72

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%)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

2024-04-25