Phase 1
N=114
A Study of Tirzepatide in Overweight and Very Overweight Participants
Obesity · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT04311411 ↗Enrolled (actual)
114
Serious AEs
0.9%
Results posted
May 2024
Primary outcome: Primary: Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 — 10.95; -523.15 kilocalories (kcal) — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tirzepatide (Drug); Placebo (Drug); Liraglutide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 |
10.95; -523.15 | <.0001 sig |
| SECONDARY Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas |
-0.0739; -0.0301; 0.0190; 0.0504; 0.0494; 0.0581 | 0.5437 |
| SECONDARY Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score |
2.15; 22.72; 8.78; -0.59; 1.66; 0.05 | <.0001 sig |
Summary
The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.
Eligibility Criteria
Inclusion Criteria
- Have stable body weight for the past 1 month prior to screening
- Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
- Women must not be pregnant or breastfeeding
Exclusion Criteria
- Have undergone or plan to undergo gastric bypass or bariatric surgery
- Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements
- Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
- Unwilling to comply with smoking and alcohol restrictions during the study
- Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
- Have a diagnosis of type 2 diabetes
Data sourced from ClinicalTrials.gov (NCT04311411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.