Assessing Debio 4126 for treating acromegaly in patients on somatostatin analogs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of Debio 4126 in maintaining insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly who have been treated with somatostatin analogs. Participants will be randomly assigned to receive either Debio 4126 or a placebo in a double-blind manner over a 36-week period. The primary outcome is to determine if Debio 4126 can effectively keep IGF-1 levels at or below the upper limit of normal compared to placebo. The study aims to provide insights into a new treatment option for patients with acromegaly.

Why it matters

Who can join: the full rules

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

Where it's running

• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Harvard Medical School
  Boston, Massachusetts, United States Recruiting
• Washington University-School of Medicine
  St Louis, Missouri, United States Recruiting
• Palm Research Center Inc
  Las Vegas, Nevada, United States Recruiting
• NYU Grossman School of Medicine
  New York, New York, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Debiopharm International S.A
• Email: clinicaltrials@debiopharm.com
• Phone: +41 21 321 01 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.