AcromegalyPhase 3OXTEND™-03NCT06930625
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
A Phase 3 study testing Debio 4126 in people with Acromegaly, run by Debiopharm International SA at 74 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Debio 4126
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 74 sitesin 21 countries
- Study dates
- 26 Nov 2025to Mar 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
74 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
74 sites in 21 countries
United States10 sites, 10 recruiting
- Recruiting
Harvard Medical School
Boston, Massachusetts, 01952
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
The Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
Palm Research Center Inc
Las Vegas, Nevada, 89128
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
Washington University-School of Medicine
St Louis, Missouri, 63110
Italy9 sites, 9 recruiting
- Recruiting
Azienda ospedaliero Universitaria di Ferrara
Ferrara, 44124
- Recruiting
Ospedale Policlinico San Martino IRCCS
Genova, 16132
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Milan, 20122
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
- Recruiting
AOU Federico II Napoli
Naples, 80131
- Recruiting
Azienda Ospedale Università di Padova
Padova, 35124
- Recruiting
Fondazione Policlinico Universitario A Gemelli
Roma, 00168
- Recruiting
University of Torino
Torino, 10126
Spain7 sites, 7 recruiting
- Recruiting
Hosiptal Universitario de la Ribera
Alzira, 46600
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario Germans Trias i Pujol
Barcelona, 08916
- Recruiting
Hospital Ramón y Cajal
Madrid, 28034
- Recruiting
Complexo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, 15705
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Brazil6 sites, 6 recruiting
- Not yet recruiting
Hospital Medical Center L2
Brasília, 70200-730
- Recruiting
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, 80030-110
- Recruiting
Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)
Fortaleza, 60430-275
- Recruiting
Hospital das Clinicas da UFMG
Minas Gerais, 30130-100
- Recruiting
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)
Rio de Janeiro, 20231-092
- Recruiting
Hospital das Clinicas - University of Sao Paulo Medical School
São Paulo, 5403000
France6 sites, 6 recruiting
- Recruiting
CHU d'Angers
Angers, 49933
- Recruiting
Hospices Civils de Lyon
Bron, 69677
- Recruiting
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
- Recruiting
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital La Conception
Marseille, 13005
- Recruiting
Hopital Haut-Leveque
Pessac, 33600
- Recruiting
CHU Toulouse - Hôpital Larrey
Toulouse, 31059
Poland5 sites, 5 recruiting
- Recruiting
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, 85-605
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
Gliwice, 44-101
- Recruiting
University Hospital Krakow
Krakow, 30-688
- Recruiting
Department of Endocrinology, Metabolism and Internal Medicine, Poznan University of Medical Sciences
Poznan, 60-355
- Recruiting
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, 52-007
Israel4 sites, 4 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 3104802
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Rabin Medical Center - Beilinson Campus
Petah Tikva, 49100
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Germany3 sites, 3 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 10117
- Recruiting
Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi
Munich, 80336
- Recruiting
Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog
Würzburg, 97080
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
- Recruiting
Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia
Budapest, 1134
- Recruiting
University of Szeged Faculty of Medicine
Szeged, 6725
Romania3 sites, 3 recruiting
- Recruiting
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, 011863
- Recruiting
Delta Health Care
Bucharest, 014142
- Recruiting
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, 400347
Austria2 sites, 2 recruiting
- Recruiting
Medical University Graz
Graz, A-8036
- Recruiting
Medizinische Universitaet Wien - Division of Endocrinology and Metabolism
Vienna, 1090
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet, Blegdamsvej 9
Copenhagen, DK-2100
- Recruiting
Zealand University Hospital
Køge, 4600
Estonia2 sites, 2 recruiting
- Recruiting
East Tallinn Central Hospital
Tallinn, 10138
- Recruiting
North Estonia Medical Centre Foundation
Tallinn, 13419
Lithuania2 sites, 2 recruiting
- Recruiting
Lithuanian Health Science University Hospital Kauno klinikos
Kaunas, LT-50161
- Recruiting
Vaidotas Urbanavicius Sole Proprietor Enterprise
Vilnius, LT-09112
Serbia2 sites, 2 recruiting
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
- Not yet recruiting
University Clinical Center of Serbia
Belgrade, 11000
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
- Recruiting
Uppsala University Hospital
Uppsala, 751 85
United Kingdom2 sites, 2 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Bulgaria1 site, 1 recruiting
- Recruiting
University Specialized Hospital for Active Treatment of Endocrinology Akad. lv Penchev EAD
Sofia, 1431
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga, LV-1002
Slovakia1 site, 1 recruiting
- Recruiting
Narodni endokrinologicky a diabetologicky ustav
Ľubochňa, 03491
About this study
Official title: 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
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
- Being tested
- Debio 4126, Placebo
- Keywords
- IGF-1, Growth hormone, Pituitary gland, Gigantism
- Medical subject headings
- Acromegaly, Pituitary Diseases, Gigantism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debio 4126Drug
IM injection, a 12-week extended-release formulation of octreotide
PlaceboDrug
IM injection of mannitol suspension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Drug: Debio 4126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double-blind Period: Percentage of Participants With IGF-1 ≤1x ULN
Measured: 36 Weeks
Secondary outcomes (10)
Arm C: Percentage of Participants With IGF-1 ≤1x ULN
Measured: 36 Weeks
Percent Change From Baseline in IGF-1 Values
Measured: Up to 108 Weeks
Percentage of Participants With IGF-1 ≤1x ULN
Measured: Up to 108 Weeks
Percentage of Participants With Growth Hormone (GH) Level <1 ng/mL
Measured: Up to 108 Weeks
Double-blind Period: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Measured: Up to 36 Weeks
Percentage of Participants Who Experienced at Least One TEAE
Measured: Up to 113 Weeks
Local Tolerability of Debio 4126 as Assessed by Erythema, Swelling, and Induration at the Injection Site Using Investigator Assessment
Measured: Up to 108 Weeks
Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score
Measured: Up to 108 Weeks
Double-blind Period: Percentage of Participants Taking Rescue Medication
Measured: Up to 36 Weeks
Trough Plasma Concentration (Ctrough) of Debio 4126
Measured: Up to 96 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start26 Nov 2025
- Primary completionJun 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930625
- Sponsor's protocol ID
- Debio 4126-301
- Other IDs
- 2024-516616-24, U1111-1310-8427
- Acronym
- OXTEND™-03
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No