RecruitingPhase 3

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

United States119 participantsStarted 2025-11-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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

Exclusion criteria

✕. 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

What they're measuring

Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN

Timeframe: 36 Weeks

Trial details

NCT IDNCT06930625

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Debiopharm International S.A

+41 21 321 01 11 clinicaltrials@debiopharm.com

View on ClinicalTrials.gov More Acromegaly trials