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

What Was Tested

This registered phase 3 trial tested Octreotide.

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.

It had 1 arm (groups): CAM2029 (octreotide subcutaneous depot) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 135 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: unresolved, drug-related serious adverse event (sae) from the preceding trial; 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.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-10-10 with completion listed for 2025-04-24.

It ran at 68 sites in United States (12), Spain (11), Turkey (Türkiye) (10), Germany (7), Russia (7) and Italy (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Characterization of adverse events (AEs) (time frame: Week 0-52).

It also tracked 4 secondary outcomes, for example Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN, Proportion of patients/partners declared competent by a healthcare professional to administer intervention and Octreotide plasma concentrations over time.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Octreotide in 135 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.