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Assessing Debio 4126 for treating acromegaly in patients on somatostatin analogs

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

Phase 3 Interventional Debiopharm International SA · NCT06930625

This study is testing if a new treatment called Debio 4126 can help people with acromegaly who are already on somatostatin analogs keep their IGF-1 levels in check better than a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment119 (estimated)
Ages18 Years and up
SexAll
SponsorDebiopharm International SA Industry-sponsored
Locations71 sites (Los Angeles, California and 70 other locations)
Trial IDNCT06930625 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been on stable doses of octreotide or lanreotide for at least 6 months and have controlled IGF-1 levels.

Not a fit: Patients with recent pituitary surgery, uncontrolled diabetes, or those who have received certain other treatments for acromegaly may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective management option for patients with acromegaly, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise in treating acromegaly with similar approaches, but the specific efficacy of Debio 4126 is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AcromegalyIGF-1Growth hormonePituitary glandGigantism
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.