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NCT06930625 | NOT YET RECRUITING | Acromegaly

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

Debiopharm International SA

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 period (Period 1) in comparison to placebo at week 36.

Condition or disease

Acromegaly

Intervention/treatment

Debio 4126

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 119 participants
Masking : DOUBLE
Masking Description : Arms A and B: Period 1 (Double-blind) and Period 2 (Open-label). Arm C: Open-label.
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2028-06
Estimated Study Completion Date : 2029-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 dopamin 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
    • A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

    Location Details

    NCT06930625

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