A Phase 1 interventional study of Tirzepatide and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 114 is above the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
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Participants received tirzepatide 5 milligrams (mg) once a week (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the subcutaneous (SC) tissue of the abdominal wall.
Drug: Tirzepatide
Participants received placebo administered into the SC tissue of the abdominal wall.
Drug: Placebo
Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Drug: Liraglutide
Administered SC.
Also known as: LY3298176
Administered SC.
Administered SC.
Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3
Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.
Time frame: Baseline, Week 3
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
Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment\*Week + Participant + Random Error.
Time frame: Baseline, Week 3
Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score
The VAS determines the effects on appetite sensations and desire for specific foods. It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 individual scores (satiety + fullness + \[100-prospective food consumption\] + \[100-hunger\]/4). The higher overall appetite score indicates less appetite, and the lower score indicates more appetite.
Time frame: Baseline, Week 3
| Milestone | Placebo | Tirzepatide | Liraglutide |
|---|---|---|---|
| Started | 39 | 37 | 38 |
| Received at least one dose of study drug | 39 | 37 | 38 |
| Completed | 34 | 31 | 36 |
| Not completed | 5 | 6 | 2 |
| Withdrew: Adverse event | 2 | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 3 | 0 |
Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.
| kilocalories (kcal) | Placebo | Tirzepatide |
|---|---|---|
| Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 | 10.95 ± 49.06 | -523.15 ± 52.78 |
Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment\*Week + Participant + Random Error.
| Arbitrary Units | Placebo | Tirzepatide | Liraglutide |
|---|---|---|---|
| Insula | -0.0739 ± 0.0740 | -0.0301 ± 0.0771 | 0.0190 ± 0.0738 |
| Medial frontal gyrus | 0.0504 ± 0.0649 | 0.0494 ± 0.0680 | 0.0581 ± 0.0658 |
| Superior temporal gyrus | 0.0132 ± 0.0838 | 0.0174 ± 0.0881 | 0.0621 ± 0.0839 |
| Precentral gyrus | 0.0441 ± 0.0580 | 0.0249 ± 0.0616 | 0.0845 ± 0.0593 |
| Cingulate gyrus | 0.0283 ± 0.0615 | 0.0214 ± 0.0643 | 0.0967 ± 0.0623 |
The VAS determines the effects on appetite sensations and desire for specific foods. It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 individual scores (satiety + fullness + \[100-prospective food consumption\] + \[100-hunger\]/4). The higher overall appetite score indicates less appetite, and the lower score indicates more appetite.
| score on a scale | Placebo | Tirzepatide | Liraglutide |
|---|---|---|---|
| Fasting (Pre-lunch) | 2.15 ± 3.02 | 22.72 ± 3.30 | 8.78 ± 3.11 |
| Postprandial (Post-lunch) | -0.59 ± 2.08 | 1.66 ± 2.23 | 0.05 ± 2.12 |
Collected over Baseline up to 10 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/39 (0%) | 0/39 (0%) | 11/39 (28.2%) |
| Tirzepatide | 0/37 (0%) | 0/37 (0%) | 29/37 (78.4%) |
| Liraglutide | 0/38 (0%) | 1/38 (2.6%) | 20/38 (52.6%) |
| Event | Placebo | Tirzepatide | Liraglutide |
|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 0/39 | 0/37 | 1/38 |
| Event | Placebo | Tirzepatide | Liraglutide |
|---|---|---|---|
| NauseaGastrointestinal disorders | 2/39 | 19/37 | 11/38 |
| VomitingGastrointestinal disorders | 1/39 | 11/37 | 4/38 |
| ConstipationGastrointestinal disorders | 0/39 | 7/37 | 5/38 |
| DyspepsiaGastrointestinal disorders | 1/39 | 7/37 | 2/38 |
| HeadacheNervous system disorders | 3/39 | 7/37 | 3/38 |
| Abdominal distensionGastrointestinal disorders | 0/39 | 5/37 | 1/38 |
| DiarrhoeaGastrointestinal disorders | 2/39 | 5/37 | 1/38 |
| Abdominal pain upperGastrointestinal disorders | 1/39 | 4/37 | 1/38 |
| FlatulenceGastrointestinal disorders | 2/39 | 4/37 | 2/38 |
| Injection site reactionGeneral disorders | 1/39 | 4/37 | 1/38 |
All participants who were randomized and received at least 1 dose of study drug.
| Age, Continuous(years) | Placebo | Tirzepatide | Liraglutide | Total |
|---|---|---|---|---|
| Mean | 46.2 ± 9.5 | 44.8 ± 10.2 | 43.7 ± 11.9 | 44.9 ± 10.5 |
| Sex: Female, Male(Participants) | Placebo | Tirzepatide | Liraglutide | Total |
|---|---|---|---|---|
| Female | 36 | 36 | 25 | 97 |
| Male | 3 | 1 | 13 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Tirzepatide | Liraglutide | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 3 | 5 |
| Not Hispanic or Latino | 37 | 36 | 35 | 108 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | Tirzepatide | Liraglutide | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 11 | 9 | 10 | 30 |
| White | 28 | 27 | 28 | 83 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | Tirzepatide | Liraglutide | Total |
|---|---|---|---|---|
| United States | 39 | 37 | 38 | 114 |
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Studies of the drug tested here: Tirzepatide