Clinical Trial

A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

Study acronym: OXTEND™-03
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2025-04-09; most recent amendment 2026-07-23.
Status change: Not Yet Recruiting → Recruiting 2025-05-08
Trial Details
NCT Number NCT06930625
Lead Sponsor Debiopharm International SA
Conditions Acromegaly
Enrollment 119 participants
Start Date 2025-11-26
Primary Completion 2028-06 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-24