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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPHH | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | 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. |
|
| Placebo | Placebo Comparator | Participants received placebo administered into the SC tissue of the abdominal wall. |
|
| Liraglutide | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States | ||
| Pennington Biomedical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40555748 | Derived | Martin CK, Carmichael OT, Carnell S, Considine RV, Kareken DA, Dydak U, Mattes RD, Scott D, Shcherbinin S, Nishiyama H, Knights A, Urva S, Biernat L, Pratt E, Haupt A, Mintun M, Otero Svaldi D, Milicevic Z, Coskun T. Tirzepatide on ingestive behavior in adults with overweight or obesity: a randomized 6-week phase 1 trial. Nat Med. 2025 Sep;31(9):3141-3150. doi: 10.1038/s41591-025-03774-9. Epub 2025 Jun 24. |
| Label | URL |
|---|---|
| A Study of Tirzepatide in Overweight and Very Overweight Participants | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall. |
| FG001 | Tirzepatide | Participants received tirzepatide 5 milligrams (mg) once weekly (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall. |
| FG002 | Liraglutide | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who were randomized and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo administered into the SC tissue of the abdominal wall. |
| BG001 | Tirzepatide | Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least 1 dose of the placebo or tirzepatide and had evaluable data for this outcome measure. | Posted | Least Squares Mean | Standard Error | kilocalories (kcal) | Baseline, Week 3 |
|
Baseline up to 10 Weeks
All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo administered into the SC tissue of the abdominal wall. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2021 | Nov 8, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2023 | Nov 8, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.
| Placebo | Drug | Administered SC. |
|
| Liraglutide | Drug | Administered SC. |
|
| 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. | Baseline, Week 3 |
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| BG002 | Liraglutide | Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
|
| 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 | 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. | All randomized participants who received at least 1 dose of the study drug and had evaluable data. Overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed includes participants who were evaluable for the given categories. | Posted | Least Squares Mean | Standard Error | Arbitrary Units | Baseline, Week 3 |
|
|
|
|
| Secondary | 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. | All randomized participants who received at least 1 dose of the study drug and had evaluable data. Overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed includes participants who were evaluable for the given categories. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 3 |
|
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 11 |
| 39 |
| EG001 | Tirzepatide | Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall. | 0 | 37 | 0 | 37 | 29 | 37 |
| EG002 | Liraglutide | Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg 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. | 0 | 38 | 1 | 38 | 20 | 38 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Medial frontal gyrus |
|
|
| Superior temporal gyrus |
|
|
| Precentral gyrus |
|
|
| Cingulate gyrus |
|
|
| 0.1806 |
| Mean Difference (Final Values) |
| 0.0930 |
| 2-Sided |
| 95 |
| -0.0441 |
| 0.2301 |
| Superiority |
| Insula | Mixed Models Analysis | 0.4720 | Mean Difference (Final Values) | -0.0491 | 2-Sided | 95 | -0.1846 | 0.0863 | Superiority |
| Medial frontal gyrus | Mixed Models Analysis | 0.9842 | Mean Difference (Final Values) | -0.0011 | 2-Sided | 95 | -0.1079 | 0.1058 | Superiority |
| Medial frontal gyrus | Mixed Models Analysis | 0.8822 | Mean Difference (Final Values) | 0.0077 | 2-Sided | 95 | -0.0949 | 0.1102 | Superiority |
| Medial frontal gyrus | Mixed Models Analysis | 0.8657 | Mean Difference (Final Values) | -0.0087 | 2-Sided | 95 | -0.1111 | 0.0937 | Superiority |
| Superior temporal gyrus | Mixed Models Analysis | 0.9599 | Mean Difference (Final Values) | 0.0043 | 2-Sided | 95 | -0.1650 | 0.1736 | Superiority |
| Superior temporal gyrus | Mixed Models Analysis | 0.5490 | Mean Difference (Final Values) | 0.0489 | 2-Sided | 95 | -0.1129 | 0.2107 | Superiority |
| Superior temporal gyrus | Mixed Models Analysis | 0.5854 | Mean Difference (Final Values) | -0.0446 | 2-Sided | 95 | -0.2068 | 0.1176 | Superiority |
| Precentral gyrus | Mixed Models Analysis | 0.7203 | Mean Difference (Final Values) | -0.0192 | 2-Sided | 95 | -0.1259 | 0.0874 | Superiority |
| Precentral gyrus | Mixed Models Analysis | 0.4330 | Mean Difference (Final Values) | 0.0404 | 2-Sided | 95 | -0.0617 | 0.1425 | Superiority |
| Precentral gyrus | Mixed Models Analysis | 0.2488 | Mean Difference (Final Values) | -0.0596 | 2-Sided | 95 | -0.1619 | 0.0426 | Superiority |
| Cingulate gyrus | Mixed Models Analysis | 0.8886 | Mean Difference (Final Values) | -0.0070 | 2-Sided | 95 | -0.1059 | 0.0919 | Superiority |
| Cingulate gyrus | Mixed Models Analysis | 0.1563 | Mean Difference (Final Values) | 0.0684 | 2-Sided | 95 | -0.0267 | 0.1635 | Superiority |
| Cingulate gyrus | Mixed Models Analysis | 0.1182 | Mean Difference (Final Values) | -0.0754 | 2-Sided | 95 | -0.1704 | 0.0196 | Superiority |
| Postprandial (Post-lunch) |
|
|
| 0.1097 |
Fasting |
| Mean Difference (Final Values) |
| 6.63 |
| 2-Sided |
| 95 |
| -1.53 |
| 14.79 |
| Superiority |
| Fasting (Pre-lunch) | Mixed Models Analysis | 0.0015 | Mean Difference (Final Values) | 13.94 | 2-Sided | 95 | 5.49 | 22.38 | Superiority |
| Postprandial (Post-lunch) | Mixed Models Analysis | 0.4469 | Mean Difference (Final Values) | 2.25 | 2-Sided | 95 | -3.60 | 8.09 | Superiority |
| Postprandial (Post-lunch) | Mixed Models Analysis | 0.8227 | Mean Difference (Final Values) | 0.64 | 2-Sided | 95 | -5.02 | 6.31 | Superiority |
| Postprandial (Post-lunch) | Mixed Models Analysis | 0.5861 | Mean Difference (Final Values) | 1.61 | 2-Sided | 95 | -4.23 | 7.45 | Superiority |