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NCT06930625PHASE3Recruiting

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

Debiopharm International SA

Start Date

11/26/2025

Completion Date

3/1/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion criteria 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 Exclusion criteria 1. Compression of optic chiasm causing visual defects 2. Symptomatic cholelithiasis or bile duct dilatation 3. Planned cholecystectomy during the trial duration 4. Acute or chronic pancreatitis 5. Pituitary radiotherapy 6. Uncontrolled hypothyroidism 7. Uncontrolled diabetes 8. Pituitary surgery within 6 months before screening or planned on trial 9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening 10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism 11. Other protocol-defined criteria apply

Interventions

DRUG

Debio 4126

DRUG

Placebo

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Conditions

Acromegaly

Locations

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Northwestern University

Chicago, Illinois 60611

United States

Harvard Medical School

Boston, Massachusetts 01952

United States

Washington University-School of Medicine

St Louis, Missouri 63110

United States

Palm Research Center Inc

Las Vegas, Nevada 89128

United States

NYU Grossman School of Medicine

New York, New York 10016

United States

The Cleveland Clinic

Cleveland, Ohio 44195

United States

The Ohio State University

Columbus, Ohio 43210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Medical University Graz

Graz, A-8036

Austria

Medizinische Universitaet Wien - Division of Endocrinology and Metabolism

Vienna, 1090

Austria

UZ Gent

Ghent, 9000

Belgium

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, 80030-110

Brazil

Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)

Fortaleza, 60430-275

Brazil

Hospital das Clinicas da UFMG

Minas Gerais, 30130-100

Brazil

Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)

Rio de Janeiro, 20231-092

Brazil

Hospital das Clinicas - University of Sao Paulo Medical School

São Paulo, 5403000

Brazil

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

Sofia, 1431

Bulgaria

Rigshospitalet, Blegdamsvej 9

Copenhagen, DK-2100

Denmark

Zealand University Hospital

Køge, 4600

Denmark

East Tallinn Central Hospital

Tallinn, 10138

Estonia

North Estonia Medical Centre Foundation

Tallinn, 13419

Estonia

CHU d'Angers

Angers, 49933

France

Hospices Civils de Lyon

Bron, 69677

France

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275

France

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

Marseille, 13005

France

Hopital Haut-Leveque

Pessac, 33600

France

CHU Toulouse - Hôpital Larrey

Toulouse, 31059

France

Charité Universitätsmedizin Berlin

Berlin, 10117

Germany

Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi

Munich, 80336

Germany

Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog

Würzburg, 97080

Germany

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083

Hungary

Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia

Budapest, 1134

Hungary

University of Szeged Faculty of Medicine

Szeged, 6725

Hungary

Bnai Zion Medical Center

Haifa, 3104802

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

Azienda ospedaliero Universitaria di Ferrara

Ferrara, 44124

Italy

Ospedale Policlinico San Martino IRCCS

Genova, 16132

Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162

Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Milan, 20122

Italy

IRCCS Ospedale San Raffaele

Milan, 20132

Italy

AOU Federico II Napoli

Naples, 80131

Italy

Azienda Ospedale Università di Padova

Padova, 35124

Italy

Fondazione Policlinico Universitario A Gemelli

Roma, 00168

Italy

University of Torino

Torino, 10126

Italy

Pauls Stradins Clinical University Hospital

Riga, LV-1002

Latvia

Lithuanian Health Science University Hospital Kauno klinikos

Kaunas, LT-50161

Lithuania

Vaidotas Urbanavicius Sole Proprietor Enterprise

Vilnius, LT-09112

Lithuania

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

Gliwice, 44-101

Poland

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

Poznan, 60-355

Poland

Uniwersytecki Szpital Kliniczny we Wroclawiu

Wroclaw, 52-007

Poland

Institutul National de Endocrinologie "C.I. Parhon"

Bucharest, 011863

Romania

Delta Health Care

Bucharest, 014142

Romania

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, 400347

Romania

University Clinical Center of Serbia

Belgrade, 11000

Serbia

University Clinical Center of Serbia

Belgrade, 11000

Serbia

Narodni endokrinologicky a diabetologicky ustav

Ľubochňa, 03491

Slovakia

Hosiptal Universitario de la Ribera

Alzira, 46600

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025

Spain

Hospital Universitario Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916

Spain

Hospital Ramón y Cajal

Madrid, 28034

Spain

Complexo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, 15705

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Karolinska University Hospital

Stockholm, 17176

Sweden

Uppsala University Hospital

Uppsala, 751 85

Sweden

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW

United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF

United Kingdom