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

PHASE3RecruitingINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

March 31, 2029

Conditions
Acromegaly
Interventions
DRUG

Debio 4126

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

DRUG

Placebo

IM injection of mannitol suspension

Trial Locations (32)

1083

NOT_YET_RECRUITING

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika, Budapest

1134

NOT_YET_RECRUITING

Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia, Budapest

6725

NOT_YET_RECRUITING

University of Szeged Faculty of Medicine, Szeged

9000

RECRUITING

UZ Gent, Ghent

10138

RECRUITING

East Tallinn Central Hospital, Tallinn

11000

RECRUITING

University Clinical Center of Serbia, Belgrade

13005

NOT_YET_RECRUITING

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

13419

RECRUITING

North Estonia Medical Centre Foundation, Tallinn

16132

NOT_YET_RECRUITING

Ospedale Policlinico San Martino IRCCS, Genova

19107

RECRUITING

Thomas Jefferson University, Philadelphia

28034

RECRUITING

Hospital Ramón y Cajal, Madrid

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

43210

RECRUITING

The Ohio State University, Columbus

44124

NOT_YET_RECRUITING

Azienda ospedaliero Universitaria di Ferrara, Ferrara

49100

NOT_YET_RECRUITING

Rabin Medical Center - Beilinson Campus, Petah Tikva

63110

RECRUITING

Washington University-School of Medicine, St Louis

64239

NOT_YET_RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

80336

NOT_YET_RECRUITING

Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi, Munich

89128

RECRUITING

Palm Research Center Inc, Las Vegas

97080

NOT_YET_RECRUITING

Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog, Würzburg

3109601

NOT_YET_RECRUITING

Rambam Health Care Campus, Haifa

01952

NOT_YET_RECRUITING

Harvard Medical School, Boston

A-8036

RECRUITING

Medical University Graz, Graz

00168

NOT_YET_RECRUITING

Fondazione Policlinico Universitario A Gemelli, Roma

LV-1002

RECRUITING

Pauls Stradins Clinical University Hospital, Riga

LT-50161

NOT_YET_RECRUITING

Lithuanian Health Science University Hospital Kauno klinikos, Kaunas

LT-09112

NOT_YET_RECRUITING

Vaidotas Urbanavicius Sole Proprietor Enterprise, Vilnius

85-605

RECRUITING

Centrum Medyczne Intercor Sp. z o.o., Bydgoszcz

014142

RECRUITING

Delta Health Care, Bucharest

03491

RECRUITING

Narodni endokrinologicky a diabetologicky ustav, Ľubochňa

08025

NOT_YET_RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

NOT_YET_RECRUITING

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors
All Listed Sponsors
lead

Debiopharm International SA

INDUSTRY