LBMON178 2nd Year Outcomes Of The Open-label Extension Of Chiasma Optimal, A Phase 3 Study Of Oral Octreotide Capsules In Acromegaly

ABSTRACT: Abstract

Background

Oral octreotide capsules (OOC) are an approved treatment option in the United States for patients with acromegaly who have previously responded to injectable somatostatin receptor ligands (iSRLs). Safety and efficacy of OOC was demonstrated in the CHIASMA OPTIMAL trial (NCT03252353), showing maintenance of response and a safety profile consistent with iSRLs. Results from the first 48 weeks of the open-label extension (OLE) of this trial suggested that this effect was durable for the long-term.

Objective

Report efficacy and safety through the second year of the OLE.

Methods

Eligible patients had the option to enroll in the OLE of CHIASMA OPTIMAL following the double-blind placebo-controlled (DPC) period. Endpoints in the second year of the OLE

SUBMITTER:  

PROVIDER: S-EPMC9627109 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature