Debio 4126 assessed for IGF-1 maintenance in acromegaly patients previously treated with somatostatin analogs

Acromegaly is a chronic endocrine disorder characterized by excessive growth hormone (GH) and insulin-like growth factor 1 (IGF-1) production, often due to a pituitary adenoma. This leads to progressive disfigurement, organomegaly, and increased morbidity and mortality, particularly from cardiovascular disease. The primary goal of treatment is to normalize GH and IGF-1 levels. Current standard-of-care often involves somatostatin analogs (SSAs) like octreotide and lanreotide, which suppress GH secretion by binding to somatostatin receptors (SSTRs), primarily SSTR2 and SSTR5. However, a significant proportion of patients do not achieve full biochemical control or experience side effects, highlighting the need for novel therapeutic options that can effectively maintain IGF-1 normalization.

This Phase 2, double-blind, placebo-controlled study aims to assess the efficacy and safety of Debio 4126 in participants with acromegaly who have been previously treated with somatostatin analogs. The primary objective is to evaluate the effect of Debio 4126 in maintaining IGF-1 levels at or below 1x the upper limit of normal (ULN) during a 36-week double-blind period (Period 1). Participants will be randomized to receive either Debio 4126 or placebo, with IGF-1 levels serving as the primary endpoint for biochemical control. The study also includes safety assessments to monitor adverse events and tolerability.