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

Launched by DEBIOPHARM INTERNATIONAL SA · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Debio 4126 to see how well it helps maintain normal levels of a hormone called insulin-like growth factor 1 (IGF-1) in people with acromegaly. Acromegaly is a condition usually caused by a benign tumor on the pituitary gland, leading to excess growth hormone. The goal is to find out if Debio 4126 can keep IGF-1 levels stable compared to a placebo (a treatment that looks like the drug but has no active ingredients) over 36 weeks.

To participate in the trial, individuals must be at least 18 years old and have been treated with specific medications for acromegaly for at least six months, with stable doses for the last three months. They should also have normal IGF-1 levels at the start of the trial. Participants will be closely monitored and will receive either Debio 4126 or the placebo during the study. It's important to note that certain health conditions and recent treatments may exclude someone from participating. This trial has not started recruiting yet, but it aims to help improve treatment options for those living with acromegaly.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Patients ≥18 years of age
• • 2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
• • 3. IGF-1 at screening ≤1x ULN
• • 4. Acromegaly diagnosis, defined as per protocol
• • 5. Adequate bone marrow, hepatic and renal function
• • 6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication
• • 7. Other protocol-defined criteria apply
• • Exclusion criteria
• • 1. Compression of optic chiasm causing visual defects
• • 2. Symptomatic cholelithiasis or bile duct dilatation
• • 3. Planned cholecystectomy during the trial duration
• • 4. Acute or chronic pancreatitis
• • 5. Pituitary radiotherapy
• • 6. Uncontrolled hypothyroidism
• • 7. Uncontrolled diabetes
• • 8. Pituitary surgery within 6 months before screening or planned on trial
• • 9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
• • 10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
• • 11. Other protocol-defined criteria apply