NCT07299084

Brief Summary

The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
6mo left

Started Jan 2026

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

December 10, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

January 14, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

December 10, 2025

Last Update Submit

May 18, 2026

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Keywords

Point of Care Ultrasound (POCUS)

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)

Secondary Outcomes (7)

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

    Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)

  • Amount of Gastric Content Volume Post-Liquid Test Meal

    Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)

  • Amount of Gastric Content Volume Post-Solid Test Meal

    Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)

  • Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Tirzepatide

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

  • Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Solid Test Meal

    Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)

  • +2 more secondary outcomes

Study Arms (2)

Participants with Type 2 Diabetes

EXPERIMENTAL

Participants will receive tirzepatide subcutaneously (SC)

Drug: Tirzepatide

Participants with Overweight or Obesity Without Type 2 Diabetes

EXPERIMENTAL

Participants will receive tirzepatide SC

Drug: Tirzepatide

Interventions

TirzepatideDRUG

Administered SC

Also known as: LY3298176
Participants with Overweight or Obesity Without Type 2 DiabetesParticipants with Type 2 Diabetes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet one of the following criteria:
  • Have type 2 diabetes
  • Have obesity
  • Have overweight with at least one health issue related to weight but without type 2 diabetes

You may not qualify if:

  • Have a condition that affects how their stomach empties
  • Have had weight loss surgery
  • Have type 1 diabetes
  • Have any major medical conditions or histories that could interfere with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Officials

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

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 23, 2025

Study Start

January 14, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)