Study S000541

Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Pre Filled Pen (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy With Overweight/Obesity (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)

ClinicalTrials.gov record

Registration

Registration: NCT07413913
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 56
Start: 2026-03-03
Primary completion: 2026-05-28
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy; Obesity
Interventions: COMBINATION_PRODUCT:Survodutide formulation A; COMBINATION_PRODUCT:Survodutide formulation B2
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:U1111-1314-3577; REGISTRY:2024-519614-30-00

Registered primary outcomes

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Up to Day 22]
Maximum measured concentration of the analyte in plasma (Cmax) [Up to Day 22]
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Up to Day 22]

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