NCT05364944

A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

A Phase 1b Study in Patients With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) to Characterize the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Debio 4126, a 12-week Prolonged-release Octreotide Formulation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).

Conditions

• Acromegaly
• GEP-NET

Interventions

Type	Name	Description
DRUG	Debio 4126	Intramuscular (IM) injection
DRUG	Sandostatin LAR	Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
DRUG	Somatuline ATG	Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-10-29
• Completion: 2024-12-03
• First posted: 2022-05-06
• Last updated: 2025-11-17

Locations

14 sites across 8 countries: Denmark, France, Germany, Israel, Italy, Poland, Spain, United Kingdom