NCT06930625 A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
| NCT ID | NCT06930625 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Debiopharm International SA |
| Condition | Acromegaly |
| Study Type | INTERVENTIONAL |
| Enrollment | 119 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 119 participants in total. It began in 2025-11-26 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06930625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acromegaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06930625 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 119 participants.
Is NCT06930625 currently recruiting?
Yes, NCT06930625 is actively recruiting participants. Contact the research team at clinicaltrials@debiopharm.com for enrollment information.
Where is the NCT06930625 trial being conducted?
This trial is being conducted at Los Angeles, United States, Chicago, United States, Boston, United States, St Louis, United States and 11 additional locations.
Who is sponsoring the NCT06930625 clinical trial?
NCT06930625 is sponsored by Debiopharm International SA. The trial plans to enroll 119 participants.