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Tests treatment safety and results for Acromegaly
Official title A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
ClinicalTrials.gov ID: NCT06930625
What this study is testing
What is Debio 4126?
Debio 4126 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for acromegaly.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients ≥18 years of age
- Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
- IGF-1 at screening ≤1x ULN
- Acromegaly diagnosis, defined as per protocol
- Adequate bone marrow, hepatic and renal function
You likely can't join if
- Compression of optic chiasm causing visual defects
- Symptomatic cholelithiasis or bile duct dilatation
- Planned cholecystectomy during the trial duration
- Acute or chronic pancreatitis
- Pituitary radiotherapy
- Uncontrolled hypothyroidism
See the full eligibility criteria
- Patients ≥18 years of age
- Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
- IGF-1 at screening ≤1x ULN
- Acromegaly diagnosis, defined as per protocol
- Adequate bone marrow, hepatic and renal function
- 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
- Other protocol-defined criteria apply
- Compression of optic chiasm causing visual defects
- Symptomatic cholelithiasis or bile duct dilatation
- Planned cholecystectomy during the trial duration
- Acute or chronic pancreatitis
- Pituitary radiotherapy
- Uncontrolled hypothyroidism
- Uncontrolled diabetes
- Pituitary surgery within 6 months before screening or planned on trial
- Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
- Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
- Other protocol-defined criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Graz, Austria
- Vienna, Austria
- Ghent, Belgium
- Curitiba, Brazil
- Fortaleza, Brazil
- Minas Gerais, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Sofia, Bulgaria
- Copenhagen, Denmark
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Las Vegas, Nevada, United States; New York, New York, United States and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.