What is the Purpose of this Study?

This study focuses on people who have been diagnosed with acromegaly and have been receiving octreotide or lanreotide, and whose insulin-like growth factor 1 ( IGF-1) level is normal. Acromegaly is characterized by high IGF-1 levels and overgrowth of body tissues, including broadening and enlargement of facial features and an increase in the size of the hands and feet. The most common cause of acromegaly is a tumor arising from cells in the pituitary gland that produce growth hormone. The purpose of the study is to determine whether treatment with an experimental drug called Debio 4126 is able to maintain a normal level of growth hormone (GH) and IGF1 in the body and whether it is safe. The main component in Debio 4126 is octreotide, a somatostatin analog medication that is already approved for the treatment of acromegaly by the U.S. Food and Drug Administration (FDA). Debio 4126 is a new injectable form of octreotide that reduces the frequency of injections to once every 12 weeks. Somatostatin analogs are medications that block the release of growth hormone from tumor cells in the pituitary gland and may also control tumor growth. Participants will stop current acromegaly treatment and receive injections of either Debio 4126 or placebo (inactive substance) once every 12 weeks. They will also undergo blood draws to measure levels of IGF-1 and other hormones in the blood at various times throughout the study.

Eligibility

Where can I participate?