Terminated
PHASE1
INTERVENTIONAL
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)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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).
Interventions
Name:
Debio 4126
Type:
DRUG
Description:
Intramuscular (IM) injection
Name:
Sandostatin LAR
Type:
DRUG
Description:
Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
Name:
Somatuline ATG
Type:
DRUG
Description:
Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration
Primary Outcomes
Measure:
Plasma Concentration of Debio 4126 in Acromegaly and GEP-NET Participants
TimeFrame:
Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
Description:
The PK of Debio 4126 will be evaluated in plasma.
Trial Information
NCT ID
NCT05364944
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Debiopharm International SA
Last Updated
December 15, 2025