Phase 1 N=36 Basic Science

A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

Overweight · Obesity · Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT04407234 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: 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 — 49384; 43523; 57049 nanograms*hours per milliliter (ng*h/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Tirzepatide (Drug); Acetaminophen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	49384; 43523; 57049	—
PRIMARY PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen	11925; 5314; 8099	—
SECONDARY Hemoglobin A1c (HbA1c) Data by Diabetic Status	5.37; 7.27; 5.29; 6.87	—
SECONDARY 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 at Steady State For Non-diabetic	44350; 39389; 54735	—
SECONDARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of Acetaminophen at Steady State For T2DM	54989; 48090; 59440	—
SECONDARY PK: Cmax of Acetaminophen at Steady State Non-diabetic	10255; 4646; 8245	—
SECONDARY PK: Cmax of Acetaminophen at Steady State For T2DM	13868; 6078; 7954	—

Summary

The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening.

Eligibility Criteria

Inclusion Criteria

Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Key Exclusion Criteria

Have undergone gastric bypass or bariatric surgery
Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
Have any lifetime history of a suicide attempt
Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
Unwilling to comply with smoking and alcohol restrictions during the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04407234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.