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New shot every 3 months could ease acromegaly treatment

NCT ID NCT06930625

Disease control Sponsor: Debiopharm International SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 25, 2026 · Updated 5 times

Summary

This phase 3 trial tests a new long-acting version of the drug octreotide (Debio 4126) for people with acromegaly, a condition caused by too much growth hormone. The drug is given as a shot every 12 weeks, instead of the usual monthly injections. The study will compare it to a placebo and also to an open-label version, to see if it keeps IGF-1 levels normal. About 119 adults who are already on stable acromegaly treatment will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Debio 4126 (a long-acting form of octreotide given as a shot every 12 weeks)
What this could lead to
If it works, this could offer people with acromegaly a more convenient treatment option with fewer injections.
What could go wrong
This is a phase 3 trial, but it's still relatively small (119 people). The new formulation may not control hormone levels as well as current treatments, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 119 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acromegaly pituitary gigantism pituitary gland disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acromegaly

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    73 sites in 21 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AOU Federico II Napoli

    RECRUITING

    Naples, 80131, Italy

  • APHP - Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, 94275, France

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

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

    RECRUITING

    Marseille, 13005, France

  • Azienda Ospedale Università di Padova

    RECRUITING

    Padova, 35124, Italy

  • Azienda ospedaliero Universitaria di Ferrara

    RECRUITING

    Ferrara, 44124, Italy

  • Bnai Zion Medical Center

    RECRUITING

    Haifa, 3104802, Israel

  • CETI - Centro de Estudos em Terapias Inovadoras

    RECRUITING

    Curitiba, 80030-110, Brazil

  • CHU Toulouse - Hôpital Larrey

    RECRUITING

    Toulouse, 31059, France

  • CHU d'Angers

    RECRUITING

    Angers, 49933, France

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centrum Medyczne Intercor Sp. z o.o.

    RECRUITING

    Bydgoszcz, 85-605, Poland

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Complexo Hospitalario Universitario de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, 15705, Spain

  • Delta Health Care

    RECRUITING

    Bucharest, 014142, Romania

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

    RECRUITING

    Poznan, 60-355, Poland

  • East Tallinn Central Hospital

    RECRUITING

    Tallinn, 10138, Estonia

  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz Endokrinologia

    RECRUITING

    Budapest, 1134, Hungary

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario A Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Harvard Medical School

    RECRUITING

    Boston, Massachusetts, 01952, United States

  • Hopital Haut-Leveque

    RECRUITING

    Pessac, 33600, France

  • Hosiptal Universitario de la Ribera

    RECRUITING

    Alzira, 46600, Spain

  • Hospices Civils de Lyon

    RECRUITING

    Bron, 69677, France

  • Hospital Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Germans Trias i Pujol

    RECRUITING

    Barcelona, 08916, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital das Clinicas - University of Sao Paulo Medical School

    RECRUITING

    São Paulo, 5403000, Brazil

  • Hospital das Clinicas da UFMG

    RECRUITING

    Minas Gerais, 30130-100, Brazil

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Instituto Estadual do Cérebro Paulo Niemeyer (IECPN)

    RECRUITING

    Rio de Janeiro, 20231-092, Brazil

  • Institutul National de Endocrinologie "C.I. Parhon"

    RECRUITING

    Bucharest, 011863, Romania

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 17176, Sweden

  • Klinikum der Universität München Medizinische Klinik und Poliklinik IV - Zi

    RECRUITING

    Munich, 80336, Germany

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Lithuanian Health Science University Hospital Kauno klinikos

    RECRUITING

    Kaunas, LT-50161, Lithuania

  • Medical University Graz

    RECRUITING

    Graz, A-8036, Austria

  • Medizinische Universitaet Wien - Division of Endocrinology and Metabolism

    RECRUITING

    Vienna, 1090, Austria

  • NYU Grossman School of Medicine

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Narodni endokrinologicky a diabetologicky ustav

    RECRUITING

    Ľubochňa, 03491, Slovakia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

    RECRUITING

    Gliwice, 44-101, Poland

  • North Estonia Medical Centre Foundation

    RECRUITING

    Tallinn, 13419, Estonia

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Nucleo de Pesquisa e Desenvolvimento de Medicamentos (NPDM)

    RECRUITING

    Fortaleza, 60430-275, Brazil

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ospedale Policlinico San Martino IRCCS

    RECRUITING

    Genova, 16132, Italy

  • Palm Research Center Inc

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Pauls Stradins Clinical University Hospital

    RECRUITING

    Riga, LV-1002, Latvia

  • Rabin Medical Center - Beilinson Campus

    RECRUITING

    Petah Tikva, 49100, Israel

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

  • Rigshospitalet, Blegdamsvej 9

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

    RECRUITING

    Budapest, 1083, Hungary

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    RECRUITING

    Cluj-Napoca, 400347, Romania

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 64239, Israel

  • The Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Center of Serbia

    NOT_YET_RECRUITING

    Belgrade, 11000, Serbia

  • University Hospital Krakow

    RECRUITING

    Krakow, 30-688, Poland

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

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

    RECRUITING

    Sofia, 1431, Bulgaria

  • University of Szeged Faculty of Medicine

    RECRUITING

    Szeged, 6725, Hungary

  • University of Torino

    RECRUITING

    Torino, 10126, Italy

  • Universitätsklinikum Würzburg - Poliklinik I - Endokrinologie u. Diabetolog

    RECRUITING

    Würzburg, 97080, Germany

  • Uniwersytecki Szpital Kliniczny we Wroclawiu

    RECRUITING

    Wroclaw, 52-007, Poland

  • Uppsala University Hospital

    RECRUITING

    Uppsala, 751 85, Sweden

  • Vaidotas Urbanavicius Sole Proprietor Enterprise

    RECRUITING

    Vilnius, LT-09112, Lithuania

  • Washington University-School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Zealand University Hospital

    RECRUITING

    Køge, 4600, Denmark

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