A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

NCT04076462 | Completed Phase 3 FDA Drug

• 2 other identifiers: HS-18-6332019-001191-11
• Study Type: interventional
• Target: 72
• Locations: 10 countries
• Sites: 63

Brief 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.

Conditions

Acromegaly

Keywords

Acromegaly; octreotide; CAM2029; phase 3

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with mean IGF-1 levels ≤1xULN

  Week 22 and 24

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

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.

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.

Drug: Matching placebo

Interventions

CAM2029 (octreotide subcutaneous depot) DRUG

Octreotide subcutaneous depot for monthly injections in acromegaly patients

Also known as: CAM2029

CAM2029 (octreotide subcutaneous depot)

Matching placebo DRUG

Matching placebo for CAM2029

Also known as: placebo

Matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
• IGF-1 levels ≤1xULN at screening
• Adequate liver, pancreatic, renal and bone marrow functions
• Normal ECG

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Camurus AB: lead

Study Sites (63)

UCLA Department of Medicine Division of Endocrinology

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

Prufen Clinical Research LLC

Miami, Florida, 33130, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University in St. Louis, School of Medicine

St Louis, Missouri, 63110, United States

Location

Palm Research Center

Las Vegas, Nevada, 89148, United States

Location

Columbia University Medical Center

New York, New York, 10018, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny Endocrinology Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

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

Frankfurt, 60590, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79601, Germany

Location

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

Munich, 80336, Germany

Location

Medicover Neuroendokrinologie

Munich, 81667, Germany

Location

Medicover Oldenburg MVZ

Oldenburg, 26122, Germany

Location

General Hospital of Athens "Laiko", Endocrinology University Clinic

Athens, 115 27, Greece

Location

Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism

Athens, 115 28, Greece

Location

General Hospital of Thessaloniki "Ippokratio"

Thessaloniki, 546 42, Greece

Location

Military Healt Center, 2nd Department of Internal Medicine

Budapest, 1062, Hungary

Location

SZTE ÁOK I.sz. Belgyógyászati Klinika

Szeged, 6720, Hungary

Location

IRCCS Policlinico San Martino

Genova, 16132, Italy

Location

Azienda Universitaria "Federico II"

Napoli, 80131, Italy

Location

Azienda Ospedaliera Padova, Department of Internal medicine

Padua, 35128, Italy

Location

Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology

Roma, Italy

Location

AOUI Verona, Policlinic of GB Rossi

Verona, 37134, Italy

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Centrum Nowoczesnych Terapii "Dobry Lekarz"

Krakow, 31-011, Poland

Location

Amicare Sp. z o.o. Sp. K.

Lodz, 90-644, Poland

Location

Piekarskie Centrum Medyczne, Szpital Miejski

Piekary Śląskie, 41-940, Poland

Location

Interregional Clinical Diagnostic Center

Kazan', 420087, Russia

Location

"Atlas" Medical Center

Moscow, Russia

Location

Sechenov Moscow First State Medical University

Moscow, Russia

Location

Vladimirsky Moscow Regional Research Clinical Institute

Moscow, Russia

Location

Novosibirsk State Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Interregional Clinical Diagnostic Center

Ryazan, 420087, Russia

Location

Saratov Regional Clinic Hospital

Saratov, 410053, Russia

Location

University Hospital Complex A Coruña

A Coruña, 15006 A, Spain

Location

University Hospital of Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

University Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Hospital Universitario de la Ribera

Valencia, 46600, Spain

Location

Akdeniz University Faculty of Medicine Department of Endocrinology

Antalya, 07985, Turkey (Türkiye)

Location

Aydın Adnan Menderes University Research and Application Hospital

Aydin, 09010, Turkey (Türkiye)

Location

Pamukkale University Faculty of Medicine Department of Endocrinology

Denizli, 20070, Turkey (Türkiye)

Location

Eskisehir Osmangazi University Medical Faculty

Eskişehir, 26480, Turkey (Türkiye)

Location

Istanbul University Medical Faculty

Fatih, 34098, Turkey (Türkiye)

Location

Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism

Kocaeli, 41000, Turkey (Türkiye)

Location

Inonu University Medical Faculty Endocrinology Department

Malatya, 44000, Turkey (Türkiye)

Location

Erciyes University Medical Faculty, Dept. of Endocrinology

Melikgazi, 38039, Turkey (Türkiye)

Location

Karadeniz Technical University Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

Location

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

Zonguldak, 67600, Turkey (Türkiye)

Location

College of Medical and Dental Sciences

Birmingham, B15 2TT, United Kingdom

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS97TF, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Salford Royal Foundation Trust

Salford, M6 8HD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40418492 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.

  PMID: 39378125 DERIVED

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Pamela Freda, M.D

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: August 19, 2019
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (10); IT (5); GB (5); DE (6); GR (3); HU (2); PL (4); US (12); ES (9); RU (7)