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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07313813

27367

H9X-MC-GBGT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Dulaglutide (LY2189265)-Solid-Meal

Experimental group

Description:

Administered subcutaneously (SC)

Treatment:

Drug: Dulaglutide

Dulaglutide (LY2189265)-Liquid-Meal

Experimental group

Description:

Administered SC

Treatment:

Drug: Dulaglutide