A Phase II Study of ISIS 766720 in Patients with Acromegaly Being Treated with Standard Therapy

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Full Title

ISIS 766720-CS2 A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 766720 (IONIS GHR-LRX, an Antisense Inhibitor of the Growth Hormone Receptor) Administered Once Every 28 Days for 16 Weeks in Patients with Acromegaly Being Treated with Long-acting Somatostatin Receptor Ligands (SRL)

Purpose

Acromegaly is a rare disease in which a tumor in the pituitary gland causes the gland to produce too much growth hormone (GH), resulting in excessive amounts of insulin-like-growth factor (IGF-1) in the blood and causing abnormal growth of bones, organs, and other body parts. In this study, researchers are evaluating the safety and effectiveness of the investigational drug ISIS 766720 in patients with acromegaly who are being treated with standard therapy using drugs called “long-acting somatostatin receptor ligands” (SRLs, such as lanreotide or octreotide). ISIS 766720 inhibits the activation of GH, lowering the amount of IGF-1 in the blood.

Patients in this study will be randomly assigned to receive one of two doses of ISIS 766720 or a placebo (inactive drug). ISIS 766720 is given as a subcutaneous (under the skin) injection. All patients will also continue to take their regular SRL treatment during the study.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acromegaly and be taking SRLs.
  • This study is for patients ages 18 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Eliza Geer at 646-888-2627.

Protocol

18-403

Phase

II

Investigator

Co-Investigators

Diseases