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RecruitingPhase 3

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

Debiopharm International SA · NCT06930625

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
119
US sites recruiting
10
Study start
November 26, 2025
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Debio 4126; Placebo

Conditions: Acromegaly

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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
  • Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening
  • Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
  • Other protocol-defined criteria apply

Recruiting US locations

Study contacts (from the official record)

  • Debiopharm International S.A · +41 21 321 01 11 · clinicaltrials@debiopharm.com
A Study to Assess the Efficacy and Safety of Debio 4126 in… (NCT06930625) | Bored Studies