Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of Debio 4126, a new octreotide formulation, compared to placebo in patients with acromegaly who were previously treated with somatostatin analogs

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with acromegaly, a condition where the body produces too much growth hormone. The study evaluates a new medication called Debio 4126, which is a 12-week formulation of octreotide, compared to a placebo and other treatments. The purpose is to determine if Debio 4126 can effectively maintain normal levels of insulin-like growth factor 1 (IGF-1) in patients who have previously been treated with medications called somatostatin analogs.

The study involves three groups of participants. Some patients will receive Debio 4126 through intramuscular injection, while others will receive a placebo. The third group will receive Debio 4126 in an open-label manner, meaning both the doctor and patient know which treatment is being given. The medication will be administered every 12 weeks, and patients will be monitored for changes in their IGF-1 levels and overall health throughout the study period.

The treatment may also include other medications such as lanreotide for some participants. Throughout the study, doctors will monitor the safety of the treatment by checking various health parameters, including blood tests, vital signs, and the size of the pituitary tumor. They will also evaluate how well patients tolerate the injections by assessing any reactions at the injection site.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period (Period 1)

    You will be randomly assigned to one of three treatment groups:

    Group A: Receiving Debio 4126 injection every 12 weeks

    Group B: Receiving placebo injection

    Group C: Receiving Debio 4126 injection (open-label group)

    This period lasts for 36 weeks

  2. Step 2

    Blood tests at Week 34 and 36

    Two blood samples will be taken to measure your IGF-1 levels (Insulin-like growth factor 1)

    The average of these two measurements will determine if your condition is well-controlled

  3. Step 3

    Treatment continuation (Period 2)

    If your IGF-1 levels are within normal limits at Week 34, you may continue to Period 2

    You may also qualify for Period 2 if your levels normalize with rescue medication by Week 48

  4. Step 4

    Regular monitoring throughout the study

    Regular checks of your: blood tests, vital signs, heart rhythm (ECG), and pituitary tumor size

    Assessment of injection site for any reactions (redness, swelling, tenderness)

    Monitoring of any side effects or adverse reactions

    Pain assessment at injection site using a visual scale

  5. Step 5

    Treatment administration

    Debio 4126 is given as an injection into the muscle every 12 weeks

    The medication comes as a ready-to-use suspension in different doses (30, 60, or 90 mg)

    The study may continue until March 2029

Who can join the trial?

9 criteria

  • Must be 18 years of age or older
  • Must be currently receiving treatment with octreotide or lanreotide (medications used to treat acromegaly) as the only treatment for at least 6 months, with no dose changes in the past 12 weeks
  • Must have IGF-1 levels (Insulin-like Growth Factor 1, a hormone that helps control growth) within normal limits at the screening visit
  • Must have a confirmed diagnosis of acromegaly according to study requirements
  • Must have normal functioning of:
    • Bone marrow (tissue that produces blood cells)
    • Liver
    • Kidneys
    • To continue to the second part of the study, patients must maintain normal IGF-1 levels at week 34, or up to week 48 if receiving additional treatment
    • Additional study requirements must also be met as defined in the study protocol

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of severe allergic reactions to similar medications
  • Patients with uncontrolled diabetes (high blood sugar levels)
  • Active or recent serious infections
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or abnormal kidney function
  • History of cancer in the past 5 years (except treated skin cancer)
  • Participation in other clinical trials within the last 30 days
  • Mental conditions that could interfere with following study procedures
  • Uncontrolled high blood pressure
  • Serious heart conditions or recent heart problems
  • Active substance abuse or alcohol dependency
  • Inability to follow study procedures or attend scheduled visits
  • Use of medications that could interfere with the study drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Debio 4126

    This is a new formulation of octreotide that lasts for 12 weeks. It is being studied for treating acromegaly, a condition where the body produces too much growth hormone. This medication belongs to a class of drugs called somatostatin analogs, which help control hormone levels in the body. The medication is designed to maintain normal levels of insulin-like growth factor 1 (IGF-1) in patients who have previously been treated with similar medications.

  • Octreotide

    This is a well-established medication used to treat acromegaly. It belongs to the somatostatin analog class of medications that help regulate hormone production in the body. It works by reducing the levels of certain hormones, including growth hormone, that are elevated in people with acromegaly.

What is already known about the treatment

Debio 4126 – A long-acting formulation of octreotide, administered as an injection every 12 weeks, designed for the treatment of acromegaly in patients who have previously received somatostatin analog therapy. This medication belongs to the pharmacological class of somatostatin analogs, which work by suppressing the production of growth hormone and insulin-like growth factor 1 (IGF-1) in the body. The drug is currently being investigated in Phase 3 clinical trials to evaluate its efficacy and safety in maintaining normal IGF-1 levels in patients with acromegaly, potentially offering a less frequent dosing schedule compared to existing treatments.

Investigated diseases

Acromegaly - A hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. The condition causes gradual enlargement of body tissues, including hands, feet, facial features, and internal organs. The excessive growth hormone production is usually caused by a benign tumor in the pituitary gland. People with acromegaly may notice gradual changes in their appearance, including larger nose, lips, tongue, and wider-spaced teeth. The condition typically develops slowly over many years, with symptoms appearing so gradually that they often go unnoticed for a long time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516616-24-00Protocol codeDebio 4126-301Estimated enrolment119 patientsSponsorDebiopharm International SA

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.