A Study to Evaluate the Effect of Fasting Duration and Temporary Withholding of Tirzepatide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
Study tests how fasting and stopping tirzepatide affects stomach emptying
Plain English Summary
A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus is a Phase 1 clinical trial sponsored by Eli Lilly and Company studying Diabetes Mellitus, Type 2, Overweight, Obesity. This study tests how long patients should fast and when to temporarily stop taking tirzepatide to help the stomach empty faster. It is for adults with type 2 diabetes, or those who are overweight or obese with related health issues. Participants will have a test meal and undergo stomach ultrasounds to measure how much food and fluid remains. Alternatives include continuing current treatment or exploring other weight management strategies. The trial aims to enroll 40 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with type 2 diabetes. Adults with obesity. Adults who are overweight and have at least one weight-related health problem (but not type 2 diabetes). You cannot join if you have a condition affecting stomach emptying, have had weight loss surgery, have type 1 diabetes, or have other major medical issues. This trial is studying Diabetes Mellitus, Type 2, Overweight, Obesity, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see how many participants have little to no food left in their stomach after a test meal, indicating normal stomach emptying. The specific primary outcome measures are: 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)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial is important for understanding how to manage potential stomach issues with tirzepatide, a common medication for diabetes and weight loss, potentially improving patient comfort and safety. This research targets Diabetes Mellitus, Type 2, Overweight, Obesity, where improved treatment options are needed.
Investor Insight
This Phase 1 study by Eli Lilly and Company investigates a common drug, suggesting a focus on optimizing its use and potentially expanding its application or improving patient experience, which could Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the study's goals and what it means for your health. You will eat a test meal and have ultrasounds to check your stomach contents at different times. You may need to adjust your fasting schedule or temporarily stop taking tirzepatide as part of the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 40 participants
Interventions
- DRUG: Tirzepatide — Administered SC
Primary Outcomes
- 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
- 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))
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Trial Locations
- Lilly Centre for Clinical Pharmacology, Singapore, Singapore
Frequently Asked Questions
What is clinical trial NCT07299084?
NCT07299084 is a Phase 1 INTERVENTIONAL study titled "A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus." It is currently recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 40 participants.
What conditions does NCT07299084 study?
This trial investigates treatments for Diabetes Mellitus, Type 2, Overweight, Obesity. The primary condition under study is Diabetes Mellitus, Type 2.
What treatments are being tested in NCT07299084?
The interventions being studied include: Tirzepatide (DRUG). Administered SC
What does Phase 1 mean for NCT07299084?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT07299084?
This trial is currently "Recruiting." It started on 2026-01-14. The estimated completion date is 2026-10.
Who is sponsoring NCT07299084?
NCT07299084 is sponsored by Eli Lilly and Company. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07299084?
The trial aims to enroll 40 participants. The trial is currently recruiting and accepting new participants.
How is NCT07299084 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07299084?
The primary outcome measures are: 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)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07299084 being conducted?
This trial is being conducted at 1 site, including Singapore (Singapore).
Where can I find official information about NCT07299084?
The official record for NCT07299084 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07299084. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07299084 testing in simple terms?
This study tests how long patients should fast and when to temporarily stop taking tirzepatide to help the stomach empty faster. It is for adults with type 2 diabetes, or those who are overweight or obese with related health issues.
Why is this trial significant?
This trial is important for understanding how to manage potential stomach issues with tirzepatide, a common medication for diabetes and weight loss, potentially improving patient comfort and safety.
What are the potential risks of participating in NCT07299084?
Potential side effects related to tirzepatide, such as nausea, vomiting, or diarrhea, may occur. Changes in stomach emptying could lead to discomfort or other digestive issues. The study involves test meals and medical procedures like ultrasounds, which carry minimal risks. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07299084?
Ask your doctor about the study's goals and what it means for your health. You will eat a test meal and have ultrasounds to check your stomach contents at different times. You may need to adjust your fasting schedule or temporarily stop taking tirzepatide as part of the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07299084 signal from an investment perspective?
This Phase 1 study by Eli Lilly and Company investigates a common drug, suggesting a focus on optimizing its use and potentially expanding its application or improving patient experience, which could This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have a test meal and undergo stomach ultrasounds to measure how much food and fluid remains. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Diabetes Mellitus, Type 2 Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.