Status:

ACTIVE_NOT_RECRUITING

A Study to Evaluate the Effect of Fasting Duration and Dulaglutide (LY2189265) Withholding on Gastric Retention in Participants With Type 2 Diabetes Mellitus

Lead Sponsor:

Eli Lilly and Company

Conditions:

Type 2 Diabetes Mellitus (T2DM)

Eligibility:

All Genders

21-70 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to evaluate how fasting and stopping the use of Dulaglutide (LY2189265) affect the amount of food and drink that stays in your stomach after a meal. Ultrasound devices wi...

Eligibility Criteria

Inclusion Criteria:

  • Participants with Type 2 Diabetes Mellitus (T2DM) as determined by medical history and have:

    • a diagnosis of T2DM for at least 6 months
    • T2DM controlled with diet and exercise alone or are on a stable dose of metformin, with or without 1 additional oral antihyperglycemic medication, a dipeptidyl peptidase-4 (DPP-4) inhibitor or sodium glucose transporter-2 inhibitor (SGLT-2i), for at least 1 month, and
    • a hemoglobin A1c value at screening of greater than or equal to 6.5% and less than or equal to 10.0%

Exclusion Criteria:

  • Have a known clinically significant gastric emptying abnormality (for example, gastroparesis or gastric outlet obstruction), have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or have had endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
  • Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data
  • Participants who have clinical laboratory test results, blood pressure, and pulse rate that are outside the normal reference range for the population
  • Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader-Willi Syndrome)

Key Trial Info

Start Date :

December 29 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT07313813

Start Date

December 29 2025

End Date

August 1 2026

Last Update

April 16 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Lilly Centre for Clinical Pharmacology

Singapore, Singapore, 138623