A Phase 1, Investigator- and Participant- Blinded, Randomized, Placebo-Controlled, Single-Dose Study to Investigate the Impact of Tirzepatide on Gastric Emptying in Adult Participants With Type 1 Diabetes Mellitus and Overweight or Obesity

Eli Lilly and Company

Summary

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.

Eligibility

Age range: 18–70 years
Sex: All
Healthy volunteers: No

Detailed 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 know…

Interventions

Drug
Tirzepatide
Administered SC.
Drug
Acetaminophen
Administered orally.
Drug
Placebo
Administered SC.

Location

Clinical Pharmacology of Miami
Miami, Florida
(305) 817-2900

A Phase 1, Investigator- and Participant- Blinded, Randomized, Placebo-Controlled, Single-Dose Study to Investigate the Impact of Tirzepatide on Gastric Emptying in Adult Participants With Type 1 Diabetes Mellitus and Overweight or Obesity

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions