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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001191-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAM2029 (octreotide subcutaneous depot) | Drug | Octreotide subcutaneous depot for monthly injections in acromegaly patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mean IGF-1 levels ≤1xULN | Week 22 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with mean IGF-1 levels ≤1xULN, including patients with dose reduction | Week 22 and 24 | |
| Proportion of patients with mean IGF-1 levels ≤1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24 | Week 22 and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Freda, M.D | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Medicine Division of Endocrinology | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40418492 | Derived | 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. | |
| 39378125 | Derived | Ferone 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. |
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Double-blind
| Matching placebo | Drug | Matching placebo for CAM2029 |
|
|
| Proportion of patients with mean GH levels <2.5 µg/L | Week 24 |
| Proportion of patients with mean GH levels <1.0 µg/L | Week 24 |
| Incidence of treatment emergent adverse events | Week 0 to 24 |
| Proportion of patients/partners declared competent by a healthcare professional to administer intervention | During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place | Week 0 to 20 and week 24 |
| Octreotide plasma concentrations over time | Week 0 to 24 |
| Stanford University Medical Center |
| Palo Alto |
| California |
| 94305 |
| United States |
| Prufen Clinical Research LLC | Miami | Florida | 33130 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University in St. Louis, School of Medicine | St Louis | Missouri | 63110 | United States |
| Palm Research Center | Las Vegas | Nevada | 89148 | United States |
| Columbia University Medical Center | New York | New York | 10018 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny Endocrinology Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Institute of Dallas | Dallas | Texas | 75231 | 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 |
| LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV | Munich | 80336 | Germany |
| Medicover Neuroendokrinologie | Munich | 81667 | Germany |
| Medicover Oldenburg MVZ | Oldenburg | 26122 | Germany |
| General Hospital of Athens "Laiko", Endocrinology University Clinic | Athens | 115 27 | Greece |
| Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism | Athens | 115 28 | Greece |
| General Hospital of Thessaloniki "Ippokratio" | Thessaloniki | 546 42 | Greece |
| Military Healt Center, 2nd Department of Internal Medicine | Budapest | 1062 | Hungary |
| SZTE ÁOK I.sz. Belgyógyászati Klinika | Szeged | 6720 | Hungary |
| IRCCS Policlinico San Martino | Genova | 16132 | Italy |
| Azienda Universitaria "Federico II" | Naples | 80131 | Italy |
| Azienda Ospedaliera Padova, Department of Internal medicine | Padova | 35128 | Italy |
| Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology | Roma | Italy |
| AOUI Verona, Policlinic of GB Rossi | Verona | 37134 | Italy |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | Krakow | 30-688 | Poland |
| Centrum Nowoczesnych Terapii "Dobry Lekarz" | Krakow | 31-011 | Poland |
| Amicare Sp. z o.o. Sp. K. | Lodz | 90-644 | Poland |
| Piekarskie Centrum Medyczne, Szpital Miejski | Piekary Śląskie | 41-940 | Poland |
| Interregional Clinical Diagnostic Center | Kazan' | 420087 | Russia |
| "Atlas" Medical Center | Moscow | Russia |
| Sechenov Moscow First State Medical University | Moscow | Russia |
| Vladimirsky Moscow Regional Research Clinical Institute | Moscow | Russia |
| Novosibirsk State Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| Interregional Clinical Diagnostic Center | Ryazan | 420087 | Russia |
| Saratov Regional Clinic Hospital | Saratov | 410053 | Russia |
| University Hospital Complex A Coruña | A Coruña | 15006 A | Spain |
| University Hospital of Alicante | Alicante | 03010 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Complejo Hospitalario Universitario Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| University Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital Universitario de la Ribera | Valencia | 46600 | Spain |
| Akdeniz University Faculty of Medicine Department of Endocrinology | Antalya | 07985 | Turkey (Türkiye) |
| Aydın Adnan Menderes University Research and Application Hospital | Aydin | 09010 | Turkey (Türkiye) |
| Pamukkale University Faculty of Medicine Department of Endocrinology | Denizli | 20070 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Medical Faculty | Eskişehir | 26480 | Turkey (Türkiye) |
| Istanbul University Medical Faculty | Fatih | 34098 | Turkey (Türkiye) |
| Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism | Kocaeli | 41000 | Turkey (Türkiye) |
| Inonu University Medical Faculty Endocrinology Department | Malatya | 44000 | Turkey (Türkiye) |
| Erciyes University Medical Faculty, Dept. of Endocrinology | Melikgazi | 38039 | Turkey (Türkiye) |
| Karadeniz Technical University Farabi Hospital | Trabzon | 61080 | Turkey (Türkiye) |
| Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus | Zonguldak | 67600 | Turkey (Türkiye) |
| College of Medical and Dental Sciences | Birmingham | B15 2TT | United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS97TF | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Salford Royal Foundation Trust | Salford | M6 8HD | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 25, 2026 | Jun 18, 2026 | 43 | ||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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