Tirzepatide for type 1 diabetes patients who are overweight or obese

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional study investigates the effects of tirzepatide on gastric emptying in adults with type 1 diabetes and BMI ≥25. Participants will undergo screening, an 8-week participation period, and follow-up. The trial uses tirzepatide compared with placebo, with acetaminophen as a gastric-emptying marker, to understand how the drug interacts with digestion in this population. Eligible participants have long-term insulin-treated type 1 diabetes, stable weight, and BMI criteria, while certain gastric conditions, prior bariatric surgery, or GLP-1 intolerance exclude enrollment. The lead sponsor is Eli Lilly, with Clinical Pharmacology of Miami as the study site.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Pharmacology of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.