| Primary | Change From Baseline in HbA1c | HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.59± 0.073
- OG001-0.69± 0.074
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| | 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 |
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| | Mixed Models Analysis | | <0.0001 | | LS Mean difference (Final Values) | -0.90 | | | 2-Sided | 95 | -1.10 | -0.69 | | | | | Superiority | | |
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| Secondary | Change From Baseline in Body Weight | LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieved HbA1c <7% | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline HbA1c Value, Baseline SGLT2i use(Yes/No), Treatment, Visit, and Treatment by Visit interaction. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieved HbA1c <=6.5% | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieved HbA1c <5.7% | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5% | Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment*Time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10% | Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment*Time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15% | Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment*Time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia) | A composite endpoint is defined as HbA1c ≤ 6.5%, weight loss ≥ 10%, and no hypoglycemia, defined as blood glucose (BG) <3.0 millimole/liter (mmol/L) and/or severe hypoglycemia. Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: For HbA1c: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Treatment + Time + Treatment*Time. For Weight: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HbA1c Group + Treatment + Time + Treatment*Time. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD |
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| Secondary | Change From Baseline in Fasting Serum Glucose (FSG) | LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares). | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | millimole per liter (mmol/L) | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Change From Baseline in Waist Circumference | LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | centimeter (cm) | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Change From Baseline in Body Mass Index (BMI) | Change from Baseline in BMI is presented. LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, excluding participants 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 | Kilogram per square meter (kg/m^2) | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached. |
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| Secondary | Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score | The IWQOL-Lite-CT is a 20-item, obesity-specific PRO (patient-reported outcome) 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, where 5 of the items comprise the physical functioning sub-domain) and psychosocial (13 items). The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning. This endpoint shows results for 'physical function domain.' | All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value for this outcome, 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 | score on a scale | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 15 mg Tirzepatide or MTD | Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached. | | OG001 | 4.5 mg Dulaglutide or MTD | |
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