A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly (ACROINNOVA 1)

July 29, 2026 updated by: Camurus AB

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • 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 Locations

  • Germany
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
      • Freiburg im Breisgau, Germany, 79601
        • Universitätsklinikum Freiburg
      • 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 Healt Center, 2nd Department of Internal Medicine
      • Szeged, Hungary, 6720
        • SZTE ÁOK I.sz. Belgyógyászati Klinika
  • Italy
      • Genova, Italy, 16132
        • IRCCS Policlinico San Martino
      • Naples, Italy, 80131
        • Azienda Universitaria "Federico II"
      • Padova, 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
  • 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
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28009
        • Hospital Universitario Gregorio Marañón
      • 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

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 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%)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAM2029 (octreotide subcutaneous depot)
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, six months treatment. 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
Placebo Comparator: Matching placebo
Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available.
Drug: Matching placebo
Matching placebo for CAM2029
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24
Time Frame: Week 22 and 24
If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 22 and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction
Time Frame: Week 22 and 24
First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants"
Week 22 and 24
Proportion of Participants With Mean IGF-1 Levels ≤1xULN at Week 22/Week 24 and Mean Growth Hormone (GH) Levels <2.5 µg/L at Week 24
Time Frame: Week 22 and 24
Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 22 and 24
Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24
Time Frame: Week 24
For the responder analysis of mean GH <2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 24
Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24
Time Frame: Week 24
For the responder analysis of mean GH <1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".
Week 24
Number of Participants With Treatment Emergent Adverse Events
Time Frame: Week 0 to 24
A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first.
Week 0 to 24
Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention
Time Frame: Week 0 to 20 and Week 24
During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration.
Week 0 to 20 and Week 24
Octreotide Plasma Concentrations Over Time
Time Frame: Week 0 to 24
Plasma samples were taken pre-dose on dosing days.
Week 0 to 24

Collaborators and Investigators

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

Sponsor

Camurus AB

Investigators

  • Principal Investigator: Pamela Freda, M.D, Columbia University

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)

August 19, 2019

Primary Completion (Actual)

May 2, 2023

Study Completion (Actual)

May 2, 2023

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-18-633
  • 2019-001191-11 (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

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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