RecruitingPhase 3NCT06930625

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

A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs

Sponsor

Debiopharm International SA

Enrollment

119 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

Acromegaly

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Debio 4126 and a drug called Placebo for people with acromegaly. The study is currently recruiting participants at 72 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDebio 4126

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

DRUGPlacebo

IM injection of mannitol suspension

Locations(72)

Cedars Sinai Medical Center

Los Angeles, California, United States

Northwestern University

Chicago, Illinois, United States

Harvard Medical School

Boston, Massachusetts, United States

Washington University-School of Medicine

St Louis, Missouri, United States

Palm Research Center Inc

Las Vegas, Nevada, United States

NYU Grossman School of Medicine

New York, New York, United States

The Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Medical University Graz

Graz, Austria

Medizinische Universitaet Wien - Division of Endocrinology and Metabolism

Vienna, Austria

UZ Gent

Ghent, Belgium

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, Brazil

Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)

Fortaleza, Brazil

Hospital das Clinicas da UFMG

Minas Gerais, Brazil

Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)

Rio de Janeiro, Brazil

Hospital das Clinicas - University of Sao Paulo Medical School

São Paulo, Brazil

University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD

Sofia, Bulgaria

Rigshospitalet, Blegdamsvej 9

Copenhagen, Denmark

Zealand University Hospital

Køge, Denmark

East Tallinn Central Hospital

Tallinn, Estonia

North Estonia Medical Centre Foundation

Tallinn, Estonia

CHU d'Angers

Angers, France

Hospices Civils de Lyon

Bron, France

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception

Marseille, France

Hopital Haut-Leveque

Pessac, France

CHU Toulouse - Hôpital Larrey

Toulouse, France

Charité Universitätsmedizin Berlin

Berlin, Germany

Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi

Munich, Germany

Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog

Würzburg, Germany

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, Hungary

Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia

Budapest, Hungary

University of Szeged Faculty of Medicine

Szeged, Hungary

Bnai Zion Medical Center

Haifa, Israel

Rambam Health Care Campus

Haifa, Israel

Rabin Medical Center - Beilinson Campus

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda ospedaliero Universitaria di Ferrara

Ferrara, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

AOU Federico II Napoli

Naples, Italy

Azienda Ospedale Università di Padova

Padova, Italy

Fondazione Policlinico Universitario A Gemelli

Roma, Italy

University of Torino

Torino, Italy

Pauls Stradins Clinical University Hospital

Riga, Latvia

Lithuanian Health Science University Hospital Kauno klinikos

Kaunas, Lithuania

Vaidotas Urbanavicius Sole Proprietor Enterprise

Vilnius, Lithuania

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

Gliwice, Poland

Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences

Poznan, Poland

Uniwersytecki Szpital Kliniczny we Wroclawiu

Wroclaw, Poland

Institutul National de Endocrinologie "C.I. Parhon"

Bucharest, Romania

Delta Health Care

Bucharest, Romania

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Romania

University Clinical Center of Serbia

Belgrade, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

Narodni endokrinologicky a diabetologicky ustav

Ľubochňa, Slovakia

Hosiptal Universitario de la Ribera

Alzira, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Germans Trias i Pujol

Barcelona, Spain

Hospital Ramón y Cajal

Madrid, Spain

Complexo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Karolinska University Hospital

Stockholm, Sweden

Uppsala University Hospital

Uppsala, Sweden

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06930625

Related Trials

An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly

NCT075835635 locations

Genetics of Endocrine Tumours - Familial Isolated Pituitary Adenoma - FIPA

NCT004611883 locations

ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly

NCT0703742045 locations

Study of MAR002 in Healthy Men

NCT071951751 location

Effects of Pasireotide Lar Therapy on Bone Metabolism

NCT071799261 location