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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Participants will receive IONIS GHR-LRx by subcutaneous injection.
Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
University of Alabama at Birmingham
Birmingham, Alabama, United States
The Incidence of Adverse Events
Incidence of adverse events (AEs), serious AEs, treatment related AEs, AEs leading to withdrawal
Time frame: Up to approximately 16 months
Percent Change from Baselines in Insulin-like Growth Factor I (IGF-1) Levels
Time frame: Baseline and at Week 26 and Week 53
Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.2 Times of Gender and Age-Adjusted Upper Limits
Time frame: Week 26 and at 28 days after the Week 53 dose
Percentage of Participants who Achieve Normalized IGF-1 Levels to Within 1.0 Times of Gender and Age-Adjusted Upper Limits
Time frame: Week 26 and at 28 days after the Week 53 dose
Percentage of Participants who Begin Other Acromegaly Medication
Time frame: Up to approximately 16 months
Time From First Dose of IONIS GHR-LRx in this open label extension (CS3) to Date of Initiation of Other Acromegaly Medications
Time frame: Up to approximately 16 months
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