Completed
PHASE2
INTERVENTIONAL
NCT03967249
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
IONIS GHR-LRx
Type:
DRUG
Description:
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Name:
Somatostatin Receptor Ligand (SRL)
Type:
DRUG
Description:
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
Primary Outcomes
Measure:
The Incidence of Adverse Events
TimeFrame:
Up to approximately 16 months
Description:
Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
Trial Information
NCT ID
NCT03967249
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Ionis Pharmaceuticals, Inc.
Last Updated
December 15, 2025