Clinical trial HS-18-633
A placebo-controlled, double-blind trial in patients with acromegaly
About clinical trial HS-18-633
Clinical trial HS-18-633 (ClinicalTrials.gov Identifier: NCT04076462) is a placebo-controlled, double-blind trial in patients with acromegaly who have been receiving regular treatment with long-acting octreotide or lanreotide. Subjects are eligible for this trial if they have been on a stable dose of octreotide or lanreotide for at least 3 months and have well-controlled levels of insulin-like growth factor 1 (IGF-1). See the ‘Are you eligible‘ section for more details.HS-18-633 overview
Aim of the clinical trial
The aim of this trial is to evaluate how effective CAM2029, a new long-acting investigational formulation of octreotide, is in controlling IGF-1 and growth hormone levels in subjects with acromegaly.
The trial will also evaluate the safety and tolerability of CAM2029. This will be done by collecting information on any side effects patients may experience while receiving treatment with CAM2029.
Other important aims of the trial are to determine how satisfied subjects are when they or their partner administer CAM2029, and to collect information about Quality of Life when treating acromegaly.
How is CAM2029 administered
CAM2029 will be given once monthly as an injection in the fatty tissue under the skin (subcutaneous injection).
Subjects in this trial will have the possibility to perform the injection themselves under supervision after being trained by trial personnel. Alternatively, the subject’s partner can also perform the injection. A total of 6 monthly doses will be given.
Treatment and placebo
In this trial, approximately two thirds of the subjects will receive CAM2029 while one third will receive placebo (the same injection as CAM2029 but without the active ingredient octreotide). This will enable the two subject groups to be compared and to determine the effects of CAM2029.
Safety first
If a subject should experience worsening of their acromegaly during the clinical trial, it is possible for them to change to the medication (rescue therapy) they were receiving prior to participating in the trial. In this case, the subject will still remain in the trial so the data that has been collected can contribute to the results obtained to evaluate CAM2029. The subject will also be able to continue in the follow-up trial.