Clinical trial HS-19-647

About clinical trial HS-19-647

Clinical trial HS-19-647 (ClinicalTrials.gov Identifier: NCT04125836) is an open-label, phase 3 trial in subjects with acromegaly who either have been receiving regular treatment with octreotide or lanreotide or have received CAM2029 in clinical trial HS-18-633.

Two groups of subjects are eligible for this trial.

• Group 1
  Subjects who have been on a stable dose of long-acting octreotide or lanreotide for at least 3 months before participating in the trial. Subjects who have also previously undergone radiotherapy (irradiation) treatment. Levels of insulin-like growth factor 1 (IGF-1) do not need to be well-controlled.

• Group 2
  Subjects who previously received treatment with CAM2029 or placebo for 6 months in clinical trial HS-18-633.
  

See the ‘Are you eligible’ section for more details.

HS-19-647 overview

Aim of the clinical trial

The trial will evaluate the safety and tolerability of CAM2029, a new long-acting investigational formulation of octreotide. This will be done by collecting information on any side effects subjects may experience while receiving acromegaly treatment with CAM2029.

In addition to safety, the trial will also evaluate how effective CAM2029 is in controlling IGF-1 and growth hormone levels in subjects with acromegaly and it effects on the subject’s quality of life.

How is CAM2029 administered

CAM2029 will be given once monthly as an injection in the fatty tissue under the skin (subcutaneous injection) using a pre-filled syringe or a pre-filled pen.

Subjects in this trial will have the possibility to perform the injection themselves under supervision by trial personnel and also at home for 4 of the doses after being trained. Alternatively, the subject’s partner can also perform the injection. A total of 13 monthly doses will be given.

Trial duration

In this trial, all subjects will receive CAM2029. The trial will last for approximately 12 months.