Debio 4126 for Acromegaly

(OXTEND™-03 Trial)

This trial tests Debio 4126, an experimental treatment for acromegaly, a condition characterized by excessive growth hormone production. The main goal is to determine if Debio 4126 can maintain normal levels of IGF-1, a growth-related protein. Participants will receive injections and may also receive a placebo, an inactive treatment, as part of the study. Suitable candidates for this trial include those who have been on stable acromegaly treatment for at least six months and have controlled IGF-1 levels. As a Phase 3 trial, this represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

The trial requires that you continue taking octreotide or lanreotide at a stable dose for at least 12 weeks before joining. If you are on other medications like pasireotide, pegvisomant, or dopamine agonists, you must stop them several months before the trial.

Research has shown that Debio 4126 was tested in earlier studies with promising safety results. Patients generally tolerated Debio 4126 well. When side effects occurred, they were usually mild. The most common issues included minor reactions at the injection site, such as redness or pain, which were short-lived.

In more advanced studies, no serious side effects directly linked to Debio 4126 have been reported. This suggests the treatment is safe for humans, although individual experiences can vary. Since this study is in an advanced phase, Debio 4126 has already passed earlier safety tests with positive results.

Debio 4126 is unique because it offers a new approach to treating acromegaly, focusing on a long-acting formulation that requires less frequent dosing. Unlike current treatments like somatostatin analogs, which often need injections every 4 weeks, Debio 4126 is administered once every 12 weeks, potentially enhancing patient convenience and adherence. Researchers are excited about its potential to maintain stable hormone levels over longer periods, which could lead to better overall management of the condition with fewer injections.

Research has shown that Debio 4126 helps maintain stable insulin-like growth factor 1 (IGF-1) levels in people with acromegaly. In earlier studies, most participants maintained stable hormone levels while using Debio 4126. In this trial, participants in Arm A will receive Debio 4126 injections every 12 weeks during a double-blind treatment period, while Arm B participants will initially receive a placebo before transitioning to Debio 4126. Arm C participants will receive Debio 4126 in an open-label treatment period. Previous trials have tested Debio 4126 and shown promise as an effective ongoing treatment for acromegaly. These results suggest that Debio 4126 could be a dependable option for managing this condition.¹²³⁴⁵