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

December 17, 2025 updated by: Camurus AB

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
      • Freiburg im Breisgau, Germany, 79601
        • Universitätsklinikum Freiburg
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Munich, Germany, 80336
        • LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
      • Munich, Germany, 81667
        • Medicover Neuroendokrinologie
      • Oldenburg, Germany, 26122
        • Medicover Oldenburg MVZ
  • Greece
      • Athens, Greece, 115 27
        • General Hospital of Athens "Laiko", Endocrinology University Clinic
      • Athens, Greece, 115 28
        • Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism
      • Thessaloniki, Greece, 546 42
        • General Hospital of Thessaloniki "Ippokratio"
  • Hungary
      • Budapest, Hungary, 1062
        • Military Health Center, 2nd Department of Internal Medicine
      • Szeged, Hungary, 6720
        • SZTE ÁOK I.sz. Belgyógyászati Klinika
  • Italy
      • Genova, Italy, 16132
        • IRCCS Policlinico San Martino
      • Napoli, Italy, 80131
        • Azienda Universitaria "Federico II"
      • Padua, Italy, 35128
        • Azienda Ospedaliera Padova, Department of Internal medicine
      • Roma, Italy
        • Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology
      • Verona, Italy, 37134
        • AOUI Verona, Policlinic of GB Rossi
  • Poland
      • Krakow, Poland, 30-688
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
      • Krakow, Poland, 31-011
        • Centrum Nowoczesnych Terapii "Dobry Lekarz"
      • Lodz, Poland, 90-644
        • AmiCare Sp. z o.o. Sp. k.
      • Piekary Śląskie, Poland, 41-940
        • Piekarskie Centrum Medyczne, Szpital Miejski
  • Russia
      • Kazan', Russia, 420087
        • Interregional Clinical Diagnostic Center
      • Moscow, Russia
        • "Atlas" Medical Center
      • Moscow, Russia
        • Sechenov Moscow First State Medical University
      • Moscow, Russia
        • Vladimirsky Moscow Regional Research Clinical Institute
      • Novosibirsk, Russia, 630087
        • Novosibirsk State Regional Clinical Hospital
      • Ryazan, Russia, 420087
        • Interregional Clinical Diagnostic Center
      • Saratov, Russia, 410053
        • Saratov Regional Clinic Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Centre Serbia, Clinic for endocrinology, diabetes and metabolic diseases
      • Novi Sad, Serbia, 21000
        • Clinical Centre of Vojvodina, Clinic for endocrinology, diabetes and metabolic diseases
  • Spain
      • A Coruña, Spain, 15006 A
        • University Hospital Complex A Coruña
      • Alicante, Spain, 03010
        • University Hospital of Alicante
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28009
        • Hospital Universitario Gregorio Marañón
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario Santiago de Compostela
      • Seville, Spain, 41013
        • University Hospital Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe
      • Valencia, Spain, 46600
        • Hospital Universitario de La Ribera
  • Turkey (Türkiye)
      • Antalya, Turkey (Türkiye), 07985
        • Akdeniz University Faculty of Medicine Department of Endocrinology
      • Aydin, Turkey (Türkiye), 09010
        • Aydın Adnan Menderes University Research and Application Hospital
      • Denizli, Turkey (Türkiye), 20070
        • Pamukkale University Faculty of Medicine Department of Endocrinology
      • Eskişehir, Turkey (Türkiye), 26480
        • Eskisehir Osmangazi University Medical Faculty
      • Fatih, Turkey (Türkiye), 34098
        • Istanbul University Medical Faculty
      • Kocaeli, Turkey (Türkiye), 41000
        • Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism
      • Malatya, Turkey (Türkiye), 44000
        • Inonu University Medical Faculty Endocrinology Department
      • Melikgazi, Turkey (Türkiye), 38039
        • Erciyes University Medical Faculty, Dept. of Endocrinology
      • Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Technical University Farabi Hospital
      • Zonguldak, Turkey (Türkiye), 67600
        • Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • College of Medical and Dental Sciences
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust
      • Leeds, United Kingdom, LS97TF
        • Leeds Teaching Hospitals NHS Trust
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Foundation Trust
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Department of Medicine Division of Endocrinology
      • Palo Alto, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Miami, Florida, United States, 33130
        • Prufen Clinical Research LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University in St. Louis, School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center
    • New York
      • New York, New York, United States, 10018
        • Columbia University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Endocrinology Associates
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)
  • 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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAM2029 (octreotide subcutaneous depot)
CAM2029 (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.
Drug: CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Other Names:
  • CAM2029

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Characterization of adverse events (AEs)
Time Frame: Week 0-52
Week 0-52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L
Time Frame: Week 50 to 52
Week 50 to 52
Proportion of patients/partners declared competent by a healthcare professional to administer intervention
Time Frame: Week 0-52
During patients/partners first three attempts during the trial period of 52 weeks whenever these visits take place
Week 0-52
Octreotide plasma concentrations over time
Time Frame: Week 0-52
Week 0-52
Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN
Time Frame: Week 50 to 52
Week 50 to 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Camurus AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diego Ferone, M.D, University of Genova Endocrinology Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-19-647
  • 2019-002190-66 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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