Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGK | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg Tirzepatide | Experimental | Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week. |
|
| 10 mg Tirzepatide | Experimental | Participants received 10mg of tirzepatide as subcutaneous injection once a week. |
|
| 15 mg Tirzepatide | Experimental | Participants received 15mg of tirzepatide as subcutaneous injection once a week. |
|
| Placebo | Placebo Comparator | Participants received placebo as subcutaneous injection once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 40 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| National Research Institute | Huntington Park | California | 90255 | United States | ||
| National Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39531161 | Derived | De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12. | |
| 37668888 |
| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1) | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide as subcutaneous injection once a week. |
| FG001 | 10 mg Tirzepatide | Participants received 10mg of tirzepatide as subcutaneous injection once a week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 15, 2020 | Jun 14, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered SC |
|
| Percentage of Participants With HbA1c Target Value of <7% |
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. |
| Week 40 |
| Change From Baseline in Fasting Serum Glucose | Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 40 |
| Percentage of Participants With HbA1c Target Value of <5.7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Week 40 |
| Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 40 |
| Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5%. | Week 40 |
| Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia | The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable. | Baseline through end of safety follow-up (up to week 44) |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported. | Week 7, 15 and 23 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| National Research Institute | Panorama City | California | 91402 | United States |
| Southern California Dermatology | Santa Ana | California | 92701 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Encore Medical Research, LLC | Hollywood | Florida | 33021 | United States |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | United States |
| South Florida Wellness & Clinical Research Institute | Margate | Florida | 33063 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Agile Clinical Research Trials | Atlanta | Georgia | 30328 | United States |
| Sky Clinical Research Network | Atlanta | Georgia | 30331 | United States |
| Cotton O'Neil Clinic | Topeka | Kansas | 66606 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| StudyMetrix Research, LLC | City of Saint Peters | Missouri | 63303 | United States |
| Aventiv Research | Columbus | Ohio | 43213 | United States |
| Intend Research | Norman | Oklahoma | 73069 | United States |
| The Corvallis Clinic P.C. | Corvallis | Oregon | 97330 | United States |
| Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | 15009 | United States |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| Dallas Diabetes Endocrine Center | Dallas | Texas | 75230 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research | Shavano Park | Texas | 78231 | United States |
| Capital Clinical Research Center | Olympia | Washington | 98502 | United States |
| Rockwood Clinic Research Center | Spokane | Washington | 99220 | United States |
| Dr. Jivraj Mehta Smarak Health Foundation | Ahmedabad | Gujarat | 380007 | India |
| Bangalore Medical College and Research Institute | Bangalore | Karnataka | 560 002 | India |
| M S Ramaiah Medical College Hospital | Bangalore | Karnataka | 560054 | India |
| BSES Municipal General Hsptl | Mumbai | Maharashtra | 400058 | India |
| Ruby Hall Clinic and Grant Medical Foundation | Pune | Maharashtra | 411001 | India |
| Vijay Vallabh Hospital | Virār | Maharashtra | 401303 | India |
| Lifepoint Multispecialty Hsptl | Wākad | Pune | 411057 | India |
| Ramdevrao Hospital | Hyderabad | Telangana | 500072 | India |
| Gandhi Hospital | Telangana | 500003 | India |
| Minamiakatsuka Clinic | Mito | Ibaraki | 311-4153 | Japan |
| Takai Naika Clinic | Kamakura | Kanagawa | 247-0056 | Japan |
| Tsuruma Kaneshiro Diabetes Clinic | Yamato | Kanagawa | 242-0004 | Japan |
| Yokohama Minoru Clinic | Yokohama | Kanagawa | 232-0064 | Japan |
| Takatsuki Red Cross Hospital | Takatsuki | Osaka | 569-1096 | Japan |
| Meiwa Hospital | Chiyodaku | Tokyo | 101 0041 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo-ku | Tokyo | 103-0027 | Japan |
| Tokyo Center Clinic | Chuo-ku | Tokyo | 103-0028 | Japan |
| IHL Shinagawa East One Medical Clinic | Minato-ku | Tokyo | 108 0075 | Japan |
| Sato Naika Clinic | Ōta-ku | Tokyo | 143-0015 | Japan |
| Hospital Universitario UANL | Monterrey | Nuevo León | 64460 | Mexico |
| Unidad Medica para la Salud Integral (UMSI) | Monterrey | Nuevo León | 66465 | Mexico |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasc | Madero | Tamaulipas | 89440 | Mexico |
| Investigacion en Salud y Metabolismo S.C | Chihuahua City | 31217 | Mexico |
| GCM Medical Group PSC | San Juan | PR | 00917 | Puerto Rico |
| Clinical Research Puerto Rico, Inc. | San Juan | 00909 | Puerto Rico |
| Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5. |
| 37526908 | Derived | Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1. |
| 35210595 | Derived | Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24. |
| 34186022 | Derived | Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27. |
| FG002 | 15 mg Tirzepatide | Participants received 15mg of tirzepatide as subcutaneous injection once a week. |
| FG003 | Placebo | Participants received placebo as subcutaneous injection once a week. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide as subcutaneous injection once a week. |
| BG001 | 10 mg Tirzepatide | Participants received 10mg of tirzepatide as subcutaneous injection once a week. |
| BG002 | 15 mg Tirzepatide | Participants received 15mg of tirzepatide as subcutaneous injection once a week. |
| BG003 | Placebo | Participants received placebo as subcutaneous injection once a week. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
| |||||||||||||||
| Hemoglobin A1c | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | Percentage of HbA1c |
|
| 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 Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 40 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | Kilograms (kg) | Baseline, Week 40 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HbA1c Target Value of <7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Number | Percentage of participants | Week 40 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Serum Glucose | Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | milligram per Deciliter (mg/dL) | Baseline, Week 40 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HbA1c Target Value of <5.7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Number | Percentage of participants | Week 40 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 40 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Weight Loss ≥5% | Percentage of Participants who Achieved Weight Loss ≥5%. | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug. | Posted | Number | Percentage of participants | Week 40 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia | The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable. | All randomized participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline value. | Posted | Mean | Standard Error | Episodes/participant/365.25 days | Baseline through end of safety follow-up (up to week 44) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (h*ng/mL) | Week 7, 15 and 23 |
|
|
Baseline to end of Safety follow-up (up to 44 weeks)
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5 mg Tirzepatide | Participants received 5 mg of Tirzepatide as subcutaneous injection, once weekly. | 0 | 121 | 5 | 121 | 50 | 121 |
| EG001 | 10 mg Tirzepatide | Participants received 10 mg of Tirzepatide as subcutaneous injection, once weekly. | 0 | 121 | 2 | 121 | 55 | 121 |
| EG002 | 15 mg Tirzepatide | Participants received 15 mg of Tirzepatide as subcutaneous injection, once weekly. | 0 | 121 | 1 | 121 | 53 | 121 |
| EG003 | Placebo | Participants received placebo as subcutaneous injection, once weekly. | 1 | 115 | 3 | 115 | 54 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2020 | Jun 14, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
| Mexico |
|
| Puerto Rico |
|
| United States |
|
| LS Mean Difference |
| -1.93 |
| 2-Sided |
| 95 |
| -2.21 |
| -1.65 |
| Superiority |
| Mixed Models Analysis | <0.001 | LS Mean Difference | -2.11 | 2-Sided | 95 | -2.39 | -1.83 | Superiority |
Participants received placebo as subcutaneous injection once a week. |
|
|
|
|
|
|
| OG003 | Placebo | Participants received placebo as subcutaneous injection once a week. |
|
|
|
Participants received placebo as subcutaneous injection once a week.
|
|
|
Participants received 15mg of tirzepatide as subcutaneous injection once a week.
| OG003 | Placebo | Participants received placebo as subcutaneous injection once a week. |
|
|
|
|
|
|
Participants received 15mg of tirzepatide as subcutaneous injection once a week. |
| OG003 | Placebo | Participants received placebo as subcutaneous injection once a week. |
|
|
| Participants |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
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