Actively Recruiting
A Phase 3 Randomized Double-Blind and Open-Label Trial to Assess the Efficacy and Safety of Debio 4126, a 12-Week Octreotide Formulation, in Adults With Acromegaly Previously Treated With Somatostatin Analogs
Led by Debiopharm International SA · Updated on 2026-05-28
119
Participants Needed
71
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Debio 4126, a 12-week extended-release formulation of octreotide, in adults with acromegaly who have previously been treated with somatostatin analogs. The study aims to assess how well Debio 4126 maintains insulin-like growth factor 1 IGF-1 levels at or below the upper limit of normal compared to a placebo during a double-blind period lasting 36 weeks. Participants will be randomly assigned to receive either Debio 4126 or a placebo by intramuscular injection once every 12 weeks for a total of three injections during the double-blind period. Those who meet specific IGF-1 criteria at week 34 may continue into an open-label period receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks. Rescue medication is available for participants whose acromegaly is not well controlled during the study. Throughout the study, participants will undergo regular assessments of IGF-1 and growth hormone levels, safety monitoring, and evaluations of local tolerability at the injection site. The main outcome is the percentage of participants maintaining IGF-1 levels at or below the upper limit of normal after 36 weeks. The study may last up to approximately 108 weeks for some participants, including follow-up and treatment periods.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Currently receiving octreotide or lanreotide alone for acromegaly for at least 6 months, with a stable dose for the last 12 weeks
- Insulin-like growth factor 1 (IGF-1) at or below the upper limit of normal at screening
- Diagnosis of acromegaly as defined by the study protocol
- Adequate bone marrow, liver, and kidney function
- For Period 2 entry: IGF-1 at or below the upper limit of normal at Week 34 or up to Week 48 if treated with rescue medication
- Other criteria defined by the study protocol
You will not qualify if you...
- Visual defects caused by compression of the optic chiasm
- Symptomatic gallstones or bile duct enlargement
- Planned gallbladder removal during the study
- Acute or chronic pancreatitis
- Previous pituitary radiotherapy
- Uncontrolled hypothyroidism
- Uncontrolled diabetes
- Pituitary surgery within 6 months before screening or planned during the trial
- Treatment with pasireotide within 6 months before screening, pegvisomant or dopamine agonists within 3 months before screening
- Recent or ongoing heart or blood vessel problems including heart failure, heart attack, stroke, certain irregular heartbeats, or pulmonary embolism
- Other criteria defined by the study protocol
Research Team
D
Debiopharm International S.A
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