NCT06930625

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

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Debio 4126	IM injection, a 12-week extended-release formulation of octreotide
DRUG	Placebo	IM injection of mannitol suspension

Timeline

• Start date: 2025-11-26
• Primary completion: 2028-06-01
• Completion: 2029-03-01
• First posted: 2025-04-16
• Last updated: 2026-03-30

Locations

71 sites across 21 countries: United States, Austria, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study