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Can a Weight-Loss drug slow stomach emptying in type 1 diabetes?

NCT ID NCT07803744

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 1 trial asks whether a single dose of tirzepatide changes how quickly the stomach empties in adults with type 1 diabetes who are overweight or have obesity. Researchers will give participants either tirzepatide or a placebo injection, then measure stomach emptying using acetaminophen, which is absorbed into the blood as the stomach empties. The study lasts about 8 weeks and includes 18 participants. The goal is to understand how this drug, already used for type 2 diabetes and weight management, might work in people with type 1 diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tirzepatide, a drug given as an injection, with acetaminophen taken by mouth to track stomach emptying
What this could lead to
If tirzepatide slows stomach emptying in people with type 1 diabetes, it could help manage weight and blood sugar in this group.
What could go wrong
This is a small, early-phase study with 18 participants, so results may not apply broadly. The drug can cause digestive side effects, and the effect on stomach emptying may be modest or vary between people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1 Obesity Overweight

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Clinical Pharmacology of Miami

    Miami, Florida, 33172, United States

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