| Primary | Percent Change From Baseline in Body Weight | Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-3.3± 0.49
- OG001-13.4± 0.48
- OG002-15.7± 0.49
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed Models Analysis | | <0.001 | | LSMean Mean Difference (Net) | -10.1 | | | 2-Sided | 95 | -11.5 | -8.8 | | | | | Superiority | | | | | Mixed Models Analysis | | <0.001 |
|
| Primary | Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline | Percentage of participants who achieve ≥5% body weight reduction from baseline | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline | Percentage of participants who achieve ≥10% body weight reduction from baseline | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline | Percentage of participants who achieve ≥15% body weight reduction from baseline | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline | Percentage of participants who achieve ≥20% body weight reduction from baseline | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Change From Baseline in Absolute Body Weight | LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Least Squares Mean | Standard Error | kilograms (kg) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Change From Baseline in Body Mass Index (BMI) | LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Least Squares Mean | Standard Error | kilograms per meter squared (kg/m^2) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) | LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Least Squares Mean | Standard Error | percentage of HbA1c | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percentage of Participants Who Achieve HbA1c <7% | Percentage of participants who achieve HbA1c <7% | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percentage of Participants Who Achieve HbA1c ≤6.5% | Percentage of participants who achieve HbA1c ≤6.5% | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percentage of Participants Who Achieve HbA1c <5.7% | Percentage of participants who achieve HbA1c <5.7% | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Change From Baseline in Fasting Glucose | LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Change From Baseline in Waist Circumference | LSMean calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Least Squares Mean | Standard Error | centimeters (cm) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled Doses of 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide) | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) | LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide) | LSMean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of AHM Used at Randomization + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. This analysis was planned to measure the outcome data under a single arm (pooled 10 mg and 15 mg Tirzepatide). | Posted | | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | Pooled Doses of 10 mg and 15 mg Tirzepatide | Participants received Tirzepatide administered SC QW. Participants in 10 mg and 15 mg Tirzepatide arms were pooled in this arm. |
| |
| Secondary | Percent Change From Baseline in Fasting Insulin | Results are reported as model-based estimates and SE from MMRM analysis using log transformation. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Posted | | Mean | Standard Error | percent change | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |
| Secondary | Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data was imputed using Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. |
|
| Secondary | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score | The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. | All randomized participants who received at least one dose of study drug. Only participants with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data was imputed using Last Observation Carried Forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received Placebo administered SC QW. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. |
|
| Secondary | Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide | Each participant was assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose. The steady state AUC was evaluated using Population PK modeling. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | | Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 10 mg Tirzepatide | Participants received 10 mg Tirzepatide administered SC QW. | | OG001 | 15 mg Tirzepatide | Participants received 15 mg Tirzepatide administered SC QW. |
| |