Loading clinical trials...

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT04125836•Camurus AB

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (68)

UCLA Department of Medicine Division of Endocrinology

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Prufen Clinical Research LLC

Miami, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University in St. Louis, School of Medicine

St Louis, Missouri, United States

Palm Research Center

Las Vegas, Nevada, United States

Columbia University Medical Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

October 10, 2019

Primary Completion Date

April 24, 2025

Completion Date

April 24, 2025

Last Updated

December 22, 2025

Enrollment

135

ACTUAL participants

Conditions

Acromegaly

Interventions

CAM2029 (octreotide subcutaneous depot)

DRUG

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

NCT00001595

PanhypopituitarismGigantism/Acromegaly+2 more

View study

ACTIVE_NOT_RECRUITINGPHASE3

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

NCT04837040

Acromegaly

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

An Investigation of Pituitary Tumors and Related Hypothalmic Disorders

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

A Study to Understand Participant's Experiences in Gastro-enteropancreatic Neuroendocrine Tumors (GEP-NETs) and Acromegaly

Endocrine Cardiomyopathy: Response to Cyclic GMP PDE5 Inhibitors in Acromegaly Cardiomyopathy

Patient and Physician Survey on Satisfaction With Somatostatin Analogue (SSA) Injections in Acromegaly in China

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients