NCT03548415

Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety, tolerability, and efficacy of IONIS-GHR-LRx in up to 60 participants with acromegaly.

Detailed description

This short-term study assessed changes in serum insulin-like growth factor 1 (IGF-1) over a 16-week treatment period in a participant population diagnosed with acromegaly being treated with long-acting somatostatin receptor ligands (SRL).

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	IONIS-GHR-LRx	IONIS GHR-LRx administered subcutaneously.
DRUG	Placebo	Placebo administered subcutaneously.

Timeline

• Start date: 2018-09-13
• Primary completion: 2021-02-18
• Completion: 2021-04-02
• First posted: 2018-06-07
• Last updated: 2022-11-14
• Results posted: 2022-11-14

Locations

33 sites across 7 countries: United States, Hungary, Lithuania, Poland, Romania, Russia, Serbia

Regulatory

• FDA-regulated drug study