Study S000390

The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04407234
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 36
Start: 2020-09-15
Primary completion: 2021-01-07
Lead sponsor: Eli Lilly and Company
Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2
Interventions: DRUG:Tirzepatide; DRUG:Acetaminophen
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPHU

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen [Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37]
PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen [Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours post-dose on Day 1, Day 2 and Day 37 , Day 2 and Day 37]

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