Study S000563

Relative Bioavailability of Two Survodutide (BI 456906) Formulations When Administered Subcutaneously Via Pre-filled Syringe Over 28 Weeks (an Open-label, Randomised, Multiple Dose, Parallel Group Trial)

ClinicalTrials.gov record

Registration

Registration: NCT07221591
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 100
Start: 2025-11-05
Primary completion: 2026-07-28
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy
Interventions: COMBINATION_PRODUCT:survodutide
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: CTIS:2025-522325-35-00; REGISTRY:U1111-1322-4700; NIH:2025

Registered primary outcomes

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [up to 232 days]
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [up to 232 days]

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