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

Purpose

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

  • Acromegaly

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
Arms A and B: Period 1 (Double-blind) and Period 2 (Open-label). Arm C: Open-label.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Debio 4126 		During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 >1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
  • Drug: Debio 4126
    IM injection, a 12-week extended-release formulation of octreotide
Placebo Comparator
Arm B: Placebo + Debio 4126 		During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 >1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.
  • Drug: Debio 4126
    IM injection, a 12-week extended-release formulation of octreotide
  • Drug: Placebo
    IM injection of mannitol suspension
Experimental
Arm C: Debio 4126 (Open-Label Treatment Period) 		During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).
  • Drug: Debio 4126
    IM injection, a 12-week extended-release formulation of octreotide

Recruiting Locations

Cedars Sinai Medical Center
Los Angeles, California 90048

Northwestern University
Chicago, Illinois 60611

Harvard Medical School
Boston, Massachusetts 01952

Washington University-School of Medicine
St Louis, Missouri 63110

Palm Research Center Inc
Las Vegas, Nevada 89128

The Cleveland Clinic
Cleveland, Ohio 44195

The Ohio State University
Columbus, Ohio 43210

Oregon Health & Science University
Portland, Oregon 97239

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

More Details

NCT ID
NCT06930625
Status
Recruiting
Sponsor
Debiopharm International SA

Study Contact

Debiopharm International S.A
+41 21 321 01 11
clinicaltrials@debiopharm.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center