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

NCT07313813 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27367H9X-MC-GBGT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 will be used to check the stomach content after a test meal. The study can last approximately 28 weeks.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Point of Care Ultrasound (POCUS)

Outcome Measures

Primary Outcomes (1)

• Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal

  Percentage of Fasting Participants with Lack of Gastric Content Retention Post-Solid Test Meal

  Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)

Secondary Outcomes (7)

• Percentage of Fasting Participants with Lack of Gastric Content Retention After Dulaglutide (LY2189265) Post-Liquid Test Meal

  Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)

• Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Liquid Test Meal After Dulaglutide (LY2189265)

  Day 123 (at 6, 8, 12, 18 and 24 hours after Day 122 liquid test meal)

• Percentage of Fasting Participants with Lack of Gastric Content Volume Post-Solid Test Meal After Dulaglutide (LY2189265)

  Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)

• Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Dulaglutide (LY2189265)

  Baseline, through 8 days after discontinuation of dulaglutide at 6, 8, 12, 18 and 24 hours

• Percentage of Participants with Grades 0, 1, 2 from Antrum Grading Scale Post-Solid Test Meal After Dulaglutide (LY2189265)

  Day 116 (at 6, 8, 12, 18 and 24 hours after baseline or Day 115 solid test meal)

Study Arms (2)

Dulaglutide (LY2189265)-Solid-Meal

EXPERIMENTAL

Administered subcutaneously (SC)

Drug: Dulaglutide

Dulaglutide (LY2189265)-Liquid-Meal

EXPERIMENTAL

Administered SC

Drug: Dulaglutide

Interventions

Dulaglutide DRUG

Administered SC

Dulaglutide (LY2189265)-Liquid-Meal; Dulaglutide (LY2189265)-Solid-Meal

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Links

• Lilly Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)