Phase 3 Trial of Debio 4126, a 12-week Octreotide Injection, for Treating Acromegaly in Patients Previously on Somatostatin Analogs

What this Trial Is About

Researchers are studying the effect of Debio 4126, a 12-week extended-release octreotide injection, in maintaining insulin-like growth factor 1 IGF-1 levels at or below the upper limit of normal in patients with acromegaly who have previously been treated with somatostatin analogs. This Phase 3 randomized trial compares Debio 4126 to a placebo during a double-blind period to evaluate its efficacy and safety. Participants in the double-blind period receive intramuscular injections of either Debio 4126 or placebo every 12 weeks for 36 weeks, totaling three injections. Those whose IGF-1 levels remain at or below the upper limit of normal at Week 34 may enter an open-label phase receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks. Rescue medication is allowed for participants whose acromegaly is not well controlled during specified times. Throughout the study, participants undergo evaluations of IGF-1 levels, growth hormone levels, and treatment tolerability, including assessments of injection site reactions and adverse events. The primary outcome is the percentage of participants with IGF-1 levels at or below the upper limit of normal at 36 weeks. Safety and efficacy measures continue for up to 108 weeks, with ongoing monitoring of medication levels and rescue treatment use.

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