NCT03967249

Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands

An Open-Label Extension Trial of IONIS GHR-LRx, an Antisense Inhibitor of the Growth Hormone Receptor Administered Monthly Subcutaneously to Patients With Acromegaly Being Treated With Long-Acting Somatostatin Receptor Ligands (SRL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands (SRL) therapy.

Detailed description

This extension study will include participants up to 60 participants with acromegaly from Study NCT03548415. All participants will remain on the same dose from the previous study and receive IONIS GHR-LRx (SC) injection once every 28 days as add-on to SRL therapy for 53 weeks. At the end of 53 weeks, participants will enter a 14-week post-treatment (PT) evaluation period.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	IONIS GHR-LRx	Participants will receive IONIS GHR-LRx by subcutaneous injection.
DRUG	Somatostatin Receptor Ligand (SRL)	Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.

Timeline

• Start date: 2019-07-25
• Primary completion: 2022-03-31
• Completion: 2022-07-07
• First posted: 2019-05-30
• Last updated: 2023-03-22

Locations

22 sites across 6 countries: United States, Hungary, Lithuania, Poland, Russia, Serbia

Regulatory

• FDA-regulated drug study