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RecruitingPhase 1

A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how tirzepatide affects how fast food leaves the stomach. It is for people with type 1 diabetes who are overweight or have obesity. The study lasts about 8 weeks, including screening and follow-up.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 1 diabetes and have used insulin for at least 1 year before screening.
  • Have a body mass index (BMI) of 25 or higher at screening. BMI is a measure based on height and weight.
  • Report that your weight has changed by no more than 5 kilograms (about 11 pounds) during the 90 days before screening.

Who can't join

  • Have a known problem with how the stomach empties that has an important effect on your health.
  • Have had weight-loss surgery, such as gastric bypass or surgery to make the stomach smaller.
  • Have a known allergy to, or cannot tolerate, acetaminophen, tirzepatide, or GLP-1 receptor agonists (a type of diabetes medicine).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

FL