Status:

RECRUITING

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

Lead Sponsor:

Debiopharm International SA

Conditions:

Acromegaly

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind per...

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

Key Trial Info

Start Date :

November 26 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2029

Estimated Enrollment :

119 Patients enrolled

Trial Details

Trial ID

NCT06930625

Start Date

November 26 2025

End Date

March 1 2029

Last Update

March 30 2026

Active Locations (71)

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Page 1 of 18 (71 locations)

1

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

2

Northwestern University

Chicago, Illinois, United States, 60611

3

Harvard Medical School

Boston, Massachusetts, United States, 01952

4

Washington University-School of Medicine

St Louis, Missouri, United States, 63110