Study S000970

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

ClinicalTrials.gov record

Registration

Registration: NCT07768813
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: RECRUITING
Enrollment: 44
Start: 2026-09-02
Primary completion: 2026-12-08
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy; Obesity
Interventions: COMBINATION_PRODUCT:Survodutide formulation A; DRUG:Survodutide formulation B2
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:U1111-1337-6323; REGISTRY:2026-526307-30-00

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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