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Not yet recruiting

NCT Number: NCT07803744

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

Location contact

Angel Lamas

PRINCIPAL_INVESTIGATOR

CONTACT

(305) 817-2900

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC.

Other names: LY3298176

Acetaminophen

Drug

Administered orally.

Placebo

Drug

Administered SC.

Primary outcomes

  1. Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen

    Time frame: Predose on Day 1 through 36 hours post dose

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Acetaminophen

    Time frame: Predose on Day 1 through 36 hours post dose

  3. PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

    Time frame: Predose on Day 1 through 36 hours post dose

Secondary outcomes

  1. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC0-∞) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

  3. PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

  4. PK: Time of Maximum Observed Drug Concentration (Tmax) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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