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

NCT06930625 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: Debio 4126-3012024-516616-24U1111-1310-8427
• Study Type: interventional
• Target: 119
• Locations: 19 countries
• Sites: 67

Brief 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

Acromegaly

Keywords

IGF-1; Growth hormone; Pituitary gland; Gigantism

Outcome Measures

Primary Outcomes (1)

• Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN

  36 Weeks

Secondary Outcomes (10)

• Arm C: Percentage of Participants With IGF-1 ≤1x ULN

  36 Weeks

• Percent Change From Baseline in IGF-1 Values

  Up to 108 Weeks

• Percentage of Participants With IGF-1 ≤1x ULN

  Up to 108 Weeks

• Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL

  Up to 108 Weeks

• Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

  Up to 36 Weeks

Study Arms (3)

Arm A: Debio 4126

EXPERIMENTAL

During Period 1 (double-blind treatment period), participants will receive an intramuscular (IM) injection of Debio 4126 once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.

Drug: Debio 4126

Arm B: Placebo + Debio 4126

PLACEBO COMPARATOR

During Period 1 (double-blind treatment period), participants will receive an IM injection of placebo once every 12 weeks over a total of 36 weeks (3 injections in total). Participants whose acromegaly is not well controlled may receive rescue medication. Eligible participants (IGF-1 ≤1x ULN on Week 34) will enter Period 2 on Week 36 and receive an open-label Debio 4126 injection once every 12 weeks over a total of 24 to 60 weeks (between 2 and 5 injections in total). Participants with IGF-1 \>1x ULN may receive rescue medication until Week 48, and may become eligible for Period 2 if their IGF-1 is ≤1x ULN.

Drug: Debio 4126; Drug: Placebo

Arm C: Debio 4126 (Open-Label Treatment Period)

EXPERIMENTAL

During the Treatment Period, participants will receive an IM injection of Debio 4126 once every 12 weeks over a total of between 60 and 96 weeks (between 5 and 8 injections in total).

Drug: Debio 4126

Interventions

Debio 4126 DRUG

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

Arm A: Debio 4126; Arm B: Placebo + Debio 4126; Arm C: Debio 4126 (Open-Label Treatment Period)

Placebo DRUG

IM injection of mannitol suspension

Arm B: Placebo + Debio 4126

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (71)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Harvard Medical School

Boston, Massachusetts, 01952, United States

RECRUITING

Washington University-School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Palm Research Center Inc

Las Vegas, Nevada, 89128, United States

RECRUITING

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Medical University Graz

Graz, A-8036, Austria

RECRUITING

Medizinische Universitaet Wien - Division of Endocrinology and Metabolism

Vienna, 1090, Austria

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, 80030-110, Brazil

RECRUITING

Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)

Fortaleza, 60430-275, Brazil

RECRUITING

Hospital das Clinicas da UFMG

Minas Gerais, 30130-100, Brazil

NOT YET RECRUITING

Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)

Rio de Janeiro, 20231-092, Brazil

RECRUITING

Hospital das Clinicas - University of Sao Paulo Medical School

São Paulo, 5403000, Brazil

RECRUITING

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

Sofia, 1431, Bulgaria

RECRUITING

Rigshospitalet, Blegdamsvej 9

Copenhagen, DK-2100, Denmark

RECRUITING

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

East Tallinn Central Hospital

Tallinn, 10138, Estonia

RECRUITING

North Estonia Medical Centre Foundation

Tallinn, 13419, Estonia

RECRUITING

CHU d'Angers

Angers, 49933, France

RECRUITING

Hospices Civils de Lyon

Bron, 69677, France

RECRUITING

APHP - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

RECRUITING

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

Marseille, 13005, France

RECRUITING

Hopital Haut-Leveque

Pessac, 33600, France

RECRUITING

CHU Toulouse - Hôpital Larrey

Toulouse, 31059, France

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi

Munich, 80336, Germany

RECRUITING

Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog

Würzburg, 97080, Germany

RECRUITING

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, 1083, Hungary

RECRUITING

Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia

Budapest, 1134, Hungary

RECRUITING

University of Szeged Faculty of Medicine

Szeged, 6725, Hungary

RECRUITING

Bnai Zion Medical Center

Haifa, 3104802, Israel

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Azienda ospedaliero Universitaria di Ferrara

Ferrara, 44124, Italy

RECRUITING

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

Milan, 20122, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

AOU Federico II Napoli

Naples, 80131, Italy

NOT YET RECRUITING

Azienda Ospedale Università di Padova

Padova, 35124, Italy

RECRUITING

Fondazione Policlinico Universitario A Gemelli

Roma, 00168, Italy

RECRUITING

University of Torino

Torino, 10126, Italy

RECRUITING

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

RECRUITING

Lithuanian Health Science University Hospital Kauno klinikos

Kaunas, LT-50161, Lithuania

RECRUITING

Vaidotas Urbanavicius Sole Proprietor Enterprise

Vilnius, LT-09112, Lithuania

RECRUITING

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

Gliwice, 44-101, Poland

RECRUITING

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

Poznan, 60-355, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny we Wroclawiu

Wroclaw, 52-007, Poland

RECRUITING

Institutul National de Endocrinologie "C.I. Parhon"

Bucharest, 011863, Romania

RECRUITING

Delta Health Care

Bucharest, 014142, Romania

RECRUITING

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, 400347, Romania

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

NOT YET RECRUITING

Narodni endokrinologicky a diabetologicky ustav

Ľubochňa, 03491, Slovakia

RECRUITING

Hosiptal Universitario de la Ribera

Alzira, 46600, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916, Spain

RECRUITING

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Complexo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, 15705, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, 751 85, Sweden

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acromegaly; Pituitary Diseases; Gigantism

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Developmental

Central Study Contacts

Debiopharm International S.A

CONTACT

+41 21 321 01 11; clinicaltrials@debiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Arms A and B: Period 1 (Double-blind) and Period 2 (Open-label). Arm C: Open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); GB (2); IT (9); BE (1); DK (2); LA (1); RO (3); ES (7); SL (1); IL (4); LI (2); BU (1); HU (3); FR (6); AU (2); US (9); DE (3); PL (4); BR (5)