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AcromegalyPhase 3NCT04125836

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

A Phase 3 study testing CAM2029 (octreotide subcutaneous depot) in people with Acromegaly, run by Camurus AB at 68 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acromegaly
What is being tested?
CAM2029 (octreotide subcutaneous depot)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
68 sitesin 11 countries
Study dates
10 Oct 2019to 24 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Male or female patients, ≥18 years at screening
  • Able to provide written informed consent to participate in the trial
  • Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
  • Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
  • IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy
  • Adequate liver, pancreatic, renal and bone marrow functions
  • Normal ECG

Who cannot join

  • For Roll-over Patients from NCT04076462:
  • Unresolved, drug-related serious adverse event (SAE) from the preceding trial
  • Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
  • For New Patients:
  • 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)
Show all 11Show fewer
  • 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 within 3 years prior to screening
  • Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)

Trial locations and contacts

68 sites in 11 countries.

68 sites in 11 countries

United States12 sites

  • University of Michigan

    Ann Arbor, Michigan, 48106

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • UCLA Department of Medicine Division of Endocrinology

    Los Angeles, California, 90095

  • Prufen Clinical Research LLC

    Miami, Florida, 33130

  • Columbia University Medical Center

    New York, New York, 10018

  • Stanford University Medical Center

    Palo Alto, California, 94305

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington University in St. Louis, School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Spain11 sites

  • University Hospital Complex A Coruña

    A Coruña, 15006 A

  • University Hospital of Alicante

    Alicante, 03010

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario Gregorio Marañón

    Madrid, 28009

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Complejo Hospitalario Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • University Hospital Virgen del Rocio

    Seville, 41013

  • Hospital Universitario y Politécnico La Fé

    Valencia, 46026

  • Hospital Universitario de la Ribera

    Valencia, 46600

Other trials in Spain

Turkey (Türkiye)10 sites

  • Akdeniz University Faculty of Medicine Department of Endocrinology

    Antalya, 07985

  • Aydın Adnan Menderes University Research and Application Hospital

    Aydin, 09010

  • Pamukkale University Faculty of Medicine Department of Endocrinology

    Denizli, 20070

  • Eskisehir Osmangazi University Medical Faculty

    Eskişehir, 26480

  • Istanbul University Medical Faculty

    Fatih, 34098

  • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism

    Kocaeli, 41000

  • Inonu University Medical Faculty Endocrinology Department

    Malatya, 44000

  • Erciyes University Medical Faculty, Dept. of Endocrinology

    Melikgazi, 38039

  • Karadeniz Technical University Farabi Hospital

    Trabzon, 61080

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

    Zonguldak, 67600

Other trials in Turkey (Türkiye)

Germany7 sites

  • Universitätsklinikum Essen

    Essen, 45147

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

    Frankfurt, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79601

  • Universitätsklinikum Leipzig

    Leipzig, 04103

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

    Munich, 80336

  • Medicover Neuroendokrinologie

    Munich, 81667

  • Medicover Oldenburg MVZ

    Oldenburg, 26122

Other trials in Germany

Russia7 sites

  • Interregional Clinical Diagnostic Center

    Kazan', 420087

  • "Atlas" Medical Center

    Moscow

  • Sechenov Moscow First State Medical University

    Moscow

  • Vladimirsky Moscow Regional Research Clinical Institute

    Moscow

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087

  • Interregional Clinical Diagnostic Center

    Ryazan, 420087

  • Saratov Regional Clinic Hospital

    Saratov, 410053

Other trials in Russia

Italy5 sites

  • IRCCS Policlinico San Martino

    Genova, 16132

  • Azienda Universitaria "Federico II"

    Naples, 80131

  • Azienda Ospedaliera Padova, Department of Internal medicine

    Padova, 35128

  • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology

    Roma

  • AOUI Verona, Policlinic of GB Rossi

    Verona, 37134

Other trials in Italy

United Kingdom5 sites

  • College of Medical and Dental Sciences

    Birmingham, B15 2TT

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS97TF

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Salford Royal Foundation Trust

    Salford, M6 8HD

Other trials in United Kingdom

Poland4 sites

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011

  • Amicare Sp. z o.o. Sp. K.

    Lodz, 90-644

  • Piekarskie Centrum Medyczne, Szpital Miejski

    Piekary Śląskie, 41-940

Other trials in Poland

Greece3 sites

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

    Athens, 115 27

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

    Athens, 115 28

  • General Hospital of Thessaloniki "Ippokratio"

    Thessaloniki, 546 42

Other trials in Greece

Hungary2 sites

  • Military Health Center, 2nd Department of Internal Medicine

    Budapest, 1062

  • SZTE ÁOK I.sz. Belgyógyászati Klinika

    Szeged, 6720

Other trials in Hungary

Serbia2 sites

  • Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases

    Belgrade, 11000

  • Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases

    Novi Sad, 21000

Other trials in Serbia

About this study

Official title: A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.

Conditions
Acromegaly
Being tested
CAM2029 (octreotide subcutaneous depot)
Keywords
Acromegaly, octreotide, CAM2029, phase 3
Medical subject headings
Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAM2029 (octreotide subcutaneous depot)Drug

    Also called CAM2029

    Octreotide subcutaneous depot for monthly injections in acromegaly patients

Study groups in NCT04125836
Study groupRoleWhat they receive
CAM2029 (octreotide subcutaneous depot)ExperimentalCAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
Receives: Drug: CAM2029 (octreotide subcutaneous depot)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of adverse events (AEs)

    Measured: Week 0-52

Secondary outcomes (4)

  1. Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN

    Measured: Week 50 to 52

  2. Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L

    Measured: Week 50 to 52

  3. Proportion of patients/partners declared competent by a healthcare professional to administer intervention

    During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place

    Measured: Week 0-52

  4. Octreotide plasma concentrations over time

    Measured: Week 0-52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2019
  2. Study start10 Oct 2019
  3. Primary completion24 Apr 2025
  4. Study completion24 Apr 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04125836
Sponsor's protocol ID
HS-19-647
Other IDs
2019-002190-66, 2019
Status last verified
Dec 2025
First submitted
11 Oct 2019
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Glatard A, Friberg-Hietala S, Keutzer L, Hansson A, Johnsson M, Tiberg F. Population Pharmacokinetic Analysis of an Octreotide Depot (CAM2029) in the Treatment of Acromegaly. Clin Pharmacokinet. 2025 Jul;64(7):1079-1092. doi: 10.1007/s40262-025-01522-3. Epub 2025 May 26.

    PubMed 40418492

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CAM2029 (octreotide subcutaneous depot) in people with Acromegaly, run by Camurus AB at 68 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Spain, Turkey (Türkiye), Germany, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterization of adverse events (AEs) (time frame: Week 0-52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04125836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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