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Can a Once-Monthly shot tame Acromegaly's hormone overdrive?

NCT ID NCT04076462

Disease control Sponsor: Camurus AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing whether a new, once-monthly injection of octreotide (CAM2029) can help people with acromegaly, a condition where the body makes too much growth hormone. Participants will receive either the study drug or a placebo for six months. The main goal is to see if the drug can bring hormone levels (IGF-1) back to normal, which could mean better control of symptoms and long-term health.

What this could mean

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

Active substance
octreotide subcutaneous depot (CAM2029)
What this could lead to
If it works, this monthly injection could offer a more convenient way to manage acromegaly, potentially replacing current treatments that require more frequent dosing.
What could go wrong
This is a phase 3 trial, but it's still possible the drug won't be more effective than placebo or may have side effects. The results will need to be confirmed in larger, longer-term studies.

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

72 people

The number who actually took part.

Started

Aug 2019

Finished

May 2023

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: * Male or female patients, ≥18 years at screening * Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed * Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly * Treatment with a stable dose of octreotide long-acting repeatable (LAR) or lanreotide autogel (ATG) for at least 3 months as monotherapy prior to screening * Insulin-like growth factor-1 (IGF-1) levels ≤1x upper limit of normal (ULN) at screening * Adequate liver, pancreatic, renal and bone marrow functions * Normal ECG Exclusion Criteria: * Growth hormone (GH) ≥2.5 μg/L at screening (cycle) * Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\] * Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) * Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated * Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening * Patients who have undergone pituitary surgery within 6 months prior to screening * Patients who have received prior pituitary irradiation * Patients with poorly controlled diabetes mellitus (hemoglobin A1c \>8.0%)

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Conditions

The condition(s) this trial relates to.

acromegaly

As listed by the trial registrant

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

Acromegaly

Contacts and locations

Locations

  • "Atlas" Medical Center

    Moscow, Russia

  • AOUI Verona, Policlinic of GB Rossi

    Verona, 37134, Italy

  • Akdeniz University Faculty of Medicine Department of Endocrinology

    Antalya, 07985, Turkey (Türkiye)

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212, United States

  • Amicare Sp. z o.o. Sp. K.

    Lodz, 90-644, Poland

  • Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism

    Athens, 115 28, Greece

  • Aydın Adnan Menderes University Research and Application Hospital

    Aydin, 09010, Turkey (Türkiye)

  • Azienda Ospedaliera Padova, Department of Internal medicine

    Padova, 35128, Italy

  • Azienda Universitaria "Federico II"

    Naples, 80131, Italy

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011, Poland

  • College of Medical and Dental Sciences

    Birmingham, B15 2TT, United Kingdom

  • Columbia University Medical Center

    New York, New York, 10018, United States

  • Complejo Hospitalario Universitario Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Erciyes University Medical Faculty, Dept. of Endocrinology

    Melikgazi, 38039, Turkey (Türkiye)

  • Eskisehir Osmangazi University Medical Faculty

    Eskişehir, 26480, Turkey (Türkiye)

  • General Hospital of Athens "Laiko", Endocrinology University Clinic

    Athens, 115 27, Greece

  • General Hospital of Thessaloniki "Ippokratio"

    Thessaloniki, 546 42, Greece

  • Hospital Universitario Gregorio Marañón

    Madrid, 28009, Spain

  • Hospital Universitario La Princesa

    Madrid, 28006, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de la Ribera

    Valencia, 46600, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026, Spain

  • IRCCS Policlinico San Martino

    Genova, 16132, Italy

  • Inonu University Medical Faculty Endocrinology Department

    Malatya, 44000, Turkey (Türkiye)

  • Interregional Clinical Diagnostic Center

    Kazan', 420087, Russia

  • Interregional Clinical Diagnostic Center

    Ryazan, 420087, Russia

  • Istanbul University Medical Faculty

    Fatih, 34098, Turkey (Türkiye)

  • Karadeniz Technical University Farabi Hospital

    Trabzon, 61080, Turkey (Türkiye)

  • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism

    Kocaeli, 41000, Turkey (Türkiye)

  • LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV

    Munich, 80336, Germany

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS97TF, United Kingdom

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medicover Neuroendokrinologie

    Munich, 81667, Germany

  • Medicover Oldenburg MVZ

    Oldenburg, 26122, Germany

  • Military Healt Center, 2nd Department of Internal Medicine

    Budapest, 1062, Hungary

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087, Russia

  • Palm Research Center

    Las Vegas, Nevada, 89148, United States

  • Pamukkale University Faculty of Medicine Department of Endocrinology

    Denizli, 20070, Turkey (Türkiye)

  • Piekarskie Centrum Medyczne, Szpital Miejski

    Piekary Śląskie, 41-940, Poland

  • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology

    Roma, Italy

  • Prufen Clinical Research LLC

    Miami, Florida, 33130, United States

  • Research Institute of Dallas

    Dallas, Texas, 75231, United States

  • SZTE ÁOK I.sz. Belgyógyászati Klinika

    Szeged, 6720, Hungary

  • Salford Royal Foundation Trust

    Salford, M6 8HD, United Kingdom

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • Saratov Regional Clinic Hospital

    Saratov, 410053, Russia

  • Sechenov Moscow First State Medical University

    Moscow, Russia

  • Stanford University Medical Center

    Palo Alto, California, 94305, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UCLA Department of Medicine Division of Endocrinology

    Los Angeles, California, 90095, United States

  • University Hospital Complex A Coruña

    A Coruña, 15006 A, Spain

  • University Hospital Virgen del Rocio

    Seville, 41013, Spain

  • University Hospital of Alicante

    Alicante, 03010, Spain

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX, United Kingdom

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Michigan

    Ann Arbor, Michigan, 48106, United States

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin

    Frankfurt, 60590, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79601, Germany

  • Vladimirsky Moscow Regional Research Clinical Institute

    Moscow, Russia

  • Washington University in St. Louis, School of Medicine

    St Louis, Missouri, 63110, United States

  • Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus

    Zonguldak, 67600, Turkey (Türkiye)

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