Debio 4126 for Acromegaly
(OXTEND™-03 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Debio 4126, an experimental treatment for acromegaly, a condition characterized by excessive growth hormone production. The main goal is to determine if Debio 4126 can maintain normal levels of IGF-1, a growth-related protein. Participants will receive injections and may also receive a placebo, an inactive treatment, as part of the study. Suitable candidates for this trial include those who have been on stable acromegaly treatment for at least six months and have controlled IGF-1 levels. As a Phase 3 trial, this represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you continue taking octreotide or lanreotide at a stable dose for at least 12 weeks before joining. If you are on other medications like pasireotide, pegvisomant, or dopamine agonists, you must stop them several months before the trial.
Is there any evidence suggesting that Debio 4126 is likely to be safe for humans?
Research has shown that Debio 4126 was tested in earlier studies with promising safety results. Patients generally tolerated Debio 4126 well. When side effects occurred, they were usually mild. The most common issues included minor reactions at the injection site, such as redness or pain, which were short-lived.
In more advanced studies, no serious side effects directly linked to Debio 4126 have been reported. This suggests the treatment is safe for humans, although individual experiences can vary. Since this study is in an advanced phase, Debio 4126 has already passed earlier safety tests with positive results.
Why do researchers think this study treatment might be promising for acromegaly?
Debio 4126 is unique because it offers a new approach to treating acromegaly, focusing on a long-acting formulation that requires less frequent dosing. Unlike current treatments like somatostatin analogs, which often need injections every 4 weeks, Debio 4126 is administered once every 12 weeks, potentially enhancing patient convenience and adherence. Researchers are excited about its potential to maintain stable hormone levels over longer periods, which could lead to better overall management of the condition with fewer injections.
What evidence suggests that Debio 4126 might be an effective treatment for acromegaly?
Research has shown that Debio 4126 helps maintain stable insulin-like growth factor 1 (IGF-1) levels in people with acromegaly. In earlier studies, most participants maintained stable hormone levels while using Debio 4126. In this trial, participants in Arm A will receive Debio 4126 injections every 12 weeks during a double-blind treatment period, while Arm B participants will initially receive a placebo before transitioning to Debio 4126. Arm C participants will receive Debio 4126 in an open-label treatment period. Previous trials have tested Debio 4126 and shown promise as an effective ongoing treatment for acromegaly. These results suggest that Debio 4126 could be a dependable option for managing this condition.12345
Are You a Good Fit for This Trial?
This trial is for adults over 18 with acromegaly, who have been treated with somatostatin analogs like octreotide or lanreotide for at least 6 months. Their IGF-1 levels must be within the normal range and they should have good bone marrow, liver, and kidney function. Participants need to maintain their IGF-1 levels to move into the second phase of the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive an IM injection of Debio 4126 or placebo once every 12 weeks over a total of 36 weeks
Open-label Treatment
Eligible participants receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Debio 4126
Trial Overview
The study tests Debio 4126's ability to keep insulin-like growth factor 1 (IGF-1) levels normal in people with acromegaly compared to a placebo. It's a blind test where neither doctors nor patients know who gets the real drug or placebo until after week 36.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
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).
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Debiopharm International SA
Lead Sponsor
Citations
Phase Ib study of DEB 4126 in Acromegaly and GEP-NET ...
In most participants, the treatment helped keep hormone levels stable. 14 people started treatment in stable condition and had results available at both the ...
A Study to Assess the Efficacy and Safety of Debio 4126 in ...
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 ...
3.
debiopharm.com
debiopharm.com/wp-content/uploads/2025/06/Pituitary-congress-poster-Debio-4126-102_2025.pdfDebio 4126, a new 12-week octreotide formulation, ...
These data support the potential of Debio 4126 administered Q12W to be an effective maintenance therapy for patients with acromegaly. • The less frequent ...
A Study to Assess the Efficacy and Safety of Debio 4126 in ...
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 ...
Acromegaly - Debiopharm - Patients
Debio 4126 was already tested in two completed clinical trials. Compared to the existing treatments typically administered every 4 weeks, Debio 4126 is injected ...
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