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

What Was Tested

The trial (phase 3) is built around Octreotide.

Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

It had two arms (groups): CAM2029 (octreotide subcutaneous depot) (experimental) and Matching placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

72 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 prior to any trial related procedures are performed. Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly. Insulin-like growth factor-1 (IGF-1) levels ≤1x upper limit of normal (ULN) at screening. Adequate liver, pancreatic, renal and bone marrow functions.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-08-19 with completion listed for 2023-05-02.

It ran at 63 sites in United States (12), Turkey (Türkiye) (10), Spain (9), Russia (7), Germany (6) and Italy (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24 (time frame: Week 22 and 24).

It also tracked 7 secondary outcomes, for example Number of Participants With Treatment Emergent Adverse Events, Proportion of Participants/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, randomized trial of Octreotide in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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