RecruitingAcromegaly

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: Debiopharm International SA

You may qualify if…

✓ 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