AcromegalyPhase 3ACROINNOVA 1NCT04076462
A Trial to Assess Efficacy and 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 63 sites in 10 countries.
Trial summary
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. 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?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 63 sitesin 10 countries
- Study dates
- 19 Aug 2019to 2 May 2023
- Phase
- Phase 3
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 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
Who cannot join
- 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%)
Trial locations and contacts
63 sites in 10 countries.
63 sites in 10 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
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
Spain9 sites
University Hospital Complex A Coruña
A Coruña, 15006 A
University Hospital of Alicante
Alicante, 03010
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Gregorio Marañón
Madrid, 28009
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, 15706
University Hospital Virgen del Rocio
Seville, 41013
Hospital Universitario y Politécnico La Fe
Valencia, 46026
Hospital Universitario de la Ribera
Valencia, 46600
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
Germany6 sites
Universitätsklinikum Essen
Essen, 45147
Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin
Frankfurt, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79601
LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV
Munich, 80336
Medicover Neuroendokrinologie
Munich, 81667
Medicover Oldenburg MVZ
Oldenburg, 26122
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
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
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
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
Hungary2 sites
Military Healt Center, 2nd Department of Internal Medicine
Budapest, 1062
SZTE ÁOK I.sz. Belgyógyászati Klinika
Szeged, 6720
About this study
Official title: 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.
- Conditions
- Acromegaly
- Being tested
- CAM2029 (octreotide subcutaneous depot), Matching placebo
- 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
Matching placeboDrug
Also called placebo
Matching placebo for CAM2029
| Study group | Role | What they receive |
|---|---|---|
| CAM2029 (octreotide subcutaneous depot) | Experimental | 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. Receives: Drug: CAM2029 (octreotide subcutaneous depot) |
| Matching placebo | Placebo comparator | Placebo (subcutaneous depot) 1.0 mL, subcutaneous injection once monthly, six months treatment. If down-titration is required, 0.5 mL dose is available. Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24
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".
Measured: Week 22 and 24
Secondary outcomes (7)
Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction
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"
Measured: 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
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".
Measured: Week 22 and 24
Proportion of Participants With Mean GH Levels <2.5 µg/L at 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".
Measured: Week 24
Proportion of Participants With Mean GH Levels <1.0 µg/L at 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".
Measured: Week 24
Number of Participants With Treatment Emergent Adverse Events
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.
Measured: Week 0 to 24
Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention
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.
Measured: Week 0 to 20 and Week 24
Octreotide Plasma Concentrations Over Time
Plasma samples were taken pre-dose on dosing days.
Measured: Week 0 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start19 Aug 2019
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camurus AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Freda, M.D, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076462
- Sponsor's protocol ID
- HS-18-633
- Other IDs
- 2019-001191-11, 2019
- Acronym
- ACROINNOVA 1
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2019
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 40418492Ferone D, Freda P, Katznelson L, Gatto F, Kadioglu P, Maffei P, Seufert J, Silverstein JM, Spencer-Segal JL, Isaeva E, Dreval A, Harrie M, Svedberg A, Tiberg F. Octreotide Subcutaneous Depot for Acromegaly: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial, ACROINNOVA 1. J Clin Endocrinol Metab. 2025 May 19;110(6):1729-1739. doi: 10.1210/clinem/dgae707.
PubMed 39378125