Clinical trial
A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity
Opening soon · Phase 1 · 1 countries · Registry ID NCT07803744
Opening soonPhase 1Interventional
What this study is about
The main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity. Participation in this study will last about 8 weeks, including screening and follow-up.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Type 1, Overweight, Obesity
Full registry criteria
Inclusion Criteria: * Have a diagnosis of type 1 diabetes mellitus (T1DM) and have been treated with insulin for at least 1 year prior to screening * Have a body mass index (BMI) greater than or equal to 25.0 kilograms per square meter (kg/m2) at screening * Are of stable weight, that is a self-reported change of 5 kg or less, for at least 90 days prior to screening Exclusion Criteria: * Participants who have a known clinically significant gastric emptying abnormality * Have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery * Have known allergies or intolerance to acetaminophen, tirzepatide, or glucagon-like peptide-1 (GLP-1) receptor agonists
Treatments and study arms
Tirzepatide
Drug
Administered SC.
Acetaminophen
Drug
Administered orally.
Placebo
Drug
Administered SC.
Primary outcomes
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of AcetaminophenPredose on Day 1 through 36 hours post dose
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of AcetaminophenPredose on Day 1 through 36 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of AcetaminophenPredose on Day 1 through 36 hours post dose
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Clinical Pharmacology of Miami🇺🇸 Miami, Florida, United States
Study contactContact
Angel LamasPrincipal Investigator