Debio 4126

DRUG3 trials

Sponsors

Debiopharm International S.A., Debiopharm International SA

Conditions

AcromegalyGEP-NET

Phase 1

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

TerminatedNCT05364944

Debiopharm International SAAcromegaly, GEP-NET

Start: 2022-05-18End: 2024-12-03Updated: 2025-11-17

Phase 3

A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

RecruitingNCT06930625

Debiopharm International SAAcromegaly

Start: 2025-11-26End: 2029-03-01Target: 119Updated: 2026-08-24

A Phase 3 randomized 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126), to assess the efficacy and safety of Debio 4126, a 12-week octreotide formulation, in patients with acromegaly previously treated with somatostatin analogs.

RecruitingCTIS2024-516616-24-00

Debiopharm International S.A.Acromegaly

Start: 2025-07-23Target: 100Updated: 2025-12-22