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

NCT06930625 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Debio 4126

IM injection, a 12-week extended-release formulation of octreotide

DRUG

Placebo

IM injection of mannitol suspension

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2028-06-30
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930625 on ClinicalTrials.gov