NCT04125836

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Camurus AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	CAM2029 (octreotide subcutaneous depot)	Octreotide subcutaneous depot for monthly injections in acromegaly patients

Timeline

• Start date: 2019-10-10
• Primary completion: 2025-04-24
• Completion: 2025-04-24
• First posted: 2019-10-14
• Last updated: 2025-12-22

Locations

68 sites across 11 countries: United States, Germany, Greece, Hungary, Italy, Poland, Russia, Serbia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study