Metabolism and Nutrition Disorder, Obesity, Overweight
Conditions
Brief summary
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight. The main purpose is to learn more about how tirzepatide affects body weight.
Interventions
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
* Have Diabetes Mellitus * Have a self-reported change in body weight \>5 kg within 3 months prior to screening * Have obesity induced by other endocrinological disorders * Have had a history of chronic or acute pancreatitis * Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years * Have any lifetime history of a suicide attempt * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Body Weight | Baseline, Week 52 | Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Week 52 | Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Week 52 | Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis. |
| Mean Change From Baseline in Waist Circumference | Baseline, Week 52 | Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Absolute Body Weight | Baseline, Week 52 | Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Body Mass Index (BMI) | Baseline, Week 52 | Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 52 | Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Fasting Glucose (FSG) | Baseline, Week 52 | Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | Baseline, Week 52 | The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables. |
| Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | Baseline, Week 52 | The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables. |
| Mean Change From Baseline in Body Weight | Baseline, Week 20 | Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | Baseline, Week 52 | LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Week 52 | Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10 mg Tirzepatide Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, and then 10 mg tirzepatide administered SC QW. | 70 |
| 15 mg Tirzepatide Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW. | 71 |
| Placebo Participants received matching placebo SC QW. | 69 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Protocol Deviation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 4 |
Baseline characteristics
| Characteristic | 10 mg Tirzepatide | 15 mg Tirzepatide | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 34.70 years STANDARD_DEVIATION 7.24 | 35.80 years STANDARD_DEVIATION 9.33 | 37.80 years STANDARD_DEVIATION 10.24 | 36.10 years STANDARD_DEVIATION 9.07 |
| Body Weight | 92.2 kilograms (kg) STANDARD_DEVIATION 16.2 | 91.3 kilograms (kg) STANDARD_DEVIATION 16.2 | 92.0 kilograms (kg) STANDARD_DEVIATION 15.8 | 91.8 kilograms (kg) STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 70 Participants | 71 Participants | 69 Participants | 210 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 70 Participants | 71 Participants | 69 Participants | 210 Participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 33 Participants | 103 Participants |
| Sex: Female, Male Male | 35 Participants | 36 Participants | 36 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 71 | 0 / 69 |
| other Total, other adverse events | 61 / 70 | 56 / 71 | 39 / 69 |
| serious Total, serious adverse events | 3 / 70 | 8 / 71 | 6 / 69 |
Outcome results
Primary
Mean Percent Change From Baseline in Body Weight
Mean Percent Change from Baseline in Body Weight. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + Sex + Presence of Comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable body weight data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Percent Change From Baseline in Body Weight | -14.4 Percent change | Standard Error 0.98 |
| 15 mg Tirzepatide | Mean Percent Change From Baseline in Body Weight | -19.9 Percent change | Standard Error 1.01 |
| Placebo | Mean Percent Change From Baseline in Body Weight | -2.4 Percent change | Standard Error 1 |
p-value: <0.00195% CI: [-14.8, -9.3]Mixed Models Analysis
p-value: <0.00195% CI: [-20.3, -14.8]Mixed Models Analysis
Primary
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of Participants who Achieve ≥5% Body Weight Reduction. A logistic regression model was used for this analysis.
Time frame: Week 52
Population: All participants who received at least one dose of study drug and had evaluable body weight data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg Tirzepatide | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | 91.43 Percentage of participants |
| 15 mg Tirzepatide | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | 92.65 Percentage of participants |
| Placebo | Percentage of Participants Who Achieve ≥5% Body Weight Reduction | 29.41 Percentage of participants |
p-value: <0.00195% CI: [8.8, 60.69]Regression, Logistic
p-value: <0.00195% CI: [9.61, 73.24]Regression, Logistic
Secondary
Mean Change From Baseline in Absolute Body Weight
Mean Change from Baseline in Absolute Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable body weight data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Absolute Body Weight | -13.1 kilograms (kg) | Standard Error 0.93 |
| 15 mg Tirzepatide | Mean Change From Baseline in Absolute Body Weight | -18.1 kilograms (kg) | Standard Error 0.95 |
| Placebo | Mean Change From Baseline in Absolute Body Weight | -2.1 kilograms (kg) | Standard Error 0.94 |
p-value: <0.00195% CI: [-13.5, -8.3]Mixed Models Analysis
p-value: <0.00195% CI: [-18.6, -13.4]Mixed Models Analysis
Secondary
Mean Change From Baseline in Body Mass Index (BMI)
Mean Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable BMI data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Body Mass Index (BMI) | -4.7 kilograms per metres squared (kg/m^2) | Standard Error 0.29 |
| 15 mg Tirzepatide | Mean Change From Baseline in Body Mass Index (BMI) | -6.4 kilograms per metres squared (kg/m^2) | Standard Error 0.3 |
| Placebo | Mean Change From Baseline in Body Mass Index (BMI) | -0.8 kilograms per metres squared (kg/m^2) | Standard Error 0.3 |
p-value: <0.00195% CI: [-4.8, -3.1]Mixed Models Analysis
p-value: <0.00195% CI: [-6.4, -4.8]Mixed Models Analysis
Secondary
Mean Change From Baseline in Body Weight
Mean Change from Baseline in Body Weight. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 20
Population: All participants who received at least one dose of study drug and had evaluable body weight data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Body Weight | -9.0 kilograms (kg) | Standard Error 0.59 |
| 15 mg Tirzepatide | Mean Change From Baseline in Body Weight | -11.1 kilograms (kg) | Standard Error 0.61 |
| Placebo | Mean Change From Baseline in Body Weight | -1.8 kilograms (kg) | Standard Error 0.6 |
p-value: <0.00195% CI: [-8.8, -5.5]Mixed Models Analysis
p-value: <0.00195% CI: [-10.9, -7.5]Mixed Models Analysis
Secondary
Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with Variable = Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable blood pressure data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -6.1 millimeters of Mercury (mmHg) | Standard Error 0.62 |
| 15 mg Tirzepatide | Mean Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -1.3 millimeters of Mercury (mmHg) | Standard Error 0.88 |
p-value: <0.00195% CI: [-6.9, -2.7]Mixed Models Analysis
Secondary
Mean Change From Baseline in Fasting Glucose (FSG)
Mean Change from Baseline in FSG. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable fasting glucose data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Fasting Glucose (FSG) | -0.25 millimoles per liter (mmol/L) | Standard Error 0.05 |
| 15 mg Tirzepatide | Mean Change From Baseline in Fasting Glucose (FSG) | -0.33 millimoles per liter (mmol/L) | Standard Error 0.052 |
| Placebo | Mean Change From Baseline in Fasting Glucose (FSG) | 0.22 millimoles per liter (mmol/L) | Standard Error 0.051 |
p-value: <0.00195% CI: [-0.61, -0.32]Mixed Models Analysis
p-value: <0.00195% CI: [-0.69, -0.4]Mixed Models Analysis
Secondary
Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable fasting insulin data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -6.5 milliunits per liter (mU/L) | Standard Error 0.42 |
| 15 mg Tirzepatide | Mean Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.2 milliunits per liter (mU/L) | Standard Error 1.09 |
95% CI: [-8.6, -4]
Secondary
Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.16 millimoles per liter (mmol/L) | Standard Error 0.013 |
| 15 mg Tirzepatide | Mean Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.10 millimoles per liter (mmol/L) | Standard Error 0.023 |
95% CI: [-0.12, -0.01]
Secondary
Mean Change From Baseline in Hemoglobin A1c (HbA1c)
Mean Change from Baseline in HbA1c. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: all participants who received at least one dose of study drug and had evaluable HbA1c data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Hemoglobin A1c (HbA1c) | -0.34 Percentage of HbA1c | Standard Error 0.032 |
| 15 mg Tirzepatide | Mean Change From Baseline in Hemoglobin A1c (HbA1c) | -0.35 Percentage of HbA1c | Standard Error 0.033 |
| Placebo | Mean Change From Baseline in Hemoglobin A1c (HbA1c) | 0.03 Percentage of HbA1c | Standard Error 0.033 |
p-value: <0.00195% CI: [-0.46, -0.28]Mixed Models Analysis
p-value: <0.00195% CI: [-0.48, -0.29]Mixed Models Analysis
Secondary
Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | 0.12 millimoles per liter (mmol/L) | Standard Error 0.017 |
| 15 mg Tirzepatide | Mean Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | 0.03 millimoles per liter (mmol/L) | Standard Error 0.023 |
95% CI: [0.03, 0.14]
Secondary
Mean 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 consists of 20 items, assessing 2 primary domains of obesity related 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. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable IWQOL-Lite-CT data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | 11.2 Score on a scale | Standard Error 1.44 |
| 15 mg Tirzepatide | Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | 12.0 Score on a scale | Standard Error 1.48 |
| Placebo | Mean Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | 3.5 Score on a scale | Standard Error 1.48 |
p-value: <0.00195% CI: [3.7, 11.8]ANCOVA
p-value: <0.00195% CI: [4.4, 12.7]ANCOVA
Secondary
Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.17 millimoles per liter (mmol/L) | Standard Error 0.056 |
| 15 mg Tirzepatide | Mean Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.11 millimoles per liter (mmol/L) | Standard Error 0.081 |
95% CI: [-0.25, 0.13]
Secondary
Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Sex + Presence of comorbidities + Treatment (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable SF-36v2 data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | 2.0 Score on a scale | Standard Error 0.4 |
| 15 mg Tirzepatide | Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | 1.9 Score on a scale | Standard Error 0.42 |
| Placebo | Mean Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | 0.8 Score on a scale | Standard Error 0.41 |
p-value: 0.04495% CI: [0, 2.3]ANCOVA
p-value: 0.0595% CI: [0, 2.3]ANCOVA
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable blood pressure data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -9.6 millimeters of Mercury (mmHg) | Standard Error 0.87 |
| 15 mg Tirzepatide | Mean Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -3.5 millimeters of Mercury (mmHg) | Standard Error 1.24 |
p-value: <0.00195% CI: [-9.1, -3.1]Mixed Models Analysis
Secondary
Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual measurement/Baseline) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.37 millimoles per liter (mmol/L) | Standard Error 0.055 |
| 15 mg Tirzepatide | Mean Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.06 millimoles per liter (mmol/L) | Standard Error 0.085 |
95% CI: [-0.51, -0.11]
Secondary
Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.63 millimoles per liter (mmol/L) | Standard Error 0.045 |
| 15 mg Tirzepatide | Mean Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.05 millimoles per liter (mmol/L) | Standard Error 0.099 |
95% CI: [-0.79, -0.37]
Secondary
Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
LS mean was determined using MMRM model using log (Actual Measurement) = log (Baseline) + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.28 millimoles per liter (mmol/L) | Standard Error 0.019 |
| 15 mg Tirzepatide | Mean Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg) | -0.03 millimoles per liter (mmol/L) | Standard Error 0.042 |
95% CI: [-0.34, -0.16]
Secondary
Mean Change From Baseline in Waist Circumference
Mean Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with Baseline + Sex + Presence of comorbidities + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 52
Population: All participants who received at least one dose of study drug and had evaluable waist circumference data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Waist Circumference | -11.9 centimeters (cm) | Standard Error 0.83 |
| 15 mg Tirzepatide | Mean Change From Baseline in Waist Circumference | -16.4 centimeters (cm) | Standard Error 0.85 |
| Placebo | Mean Change From Baseline in Waist Circumference | -2.7 centimeters (cm) | Standard Error 0.84 |
p-value: <0.00195% CI: [-11.5, -6.9]Mixed Models Analysis
p-value: <0.00195% CI: [-16, -11.3]Mixed Models Analysis
Secondary
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of Participants who Achieve ≥10% Body Weight Reduction. A logistic regression model was used for this analysis.
Time frame: Week 52
Population: All participants who received at least one dose of study drug and had evaluable body weight data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg Tirzepatide | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | 70.0 Percentage of participants |
| 15 mg Tirzepatide | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | 83.82 Percentage of participants |
| Placebo | Percentage of Participants Who Achieve ≥10% Body Weight Reduction | 14.71 Percentage of participants |
p-value: <0.00195% CI: [5.63, 30.89]Regression, Logistic
p-value: <0.00195% CI: [11.23, 72.71]Regression, Logistic
Secondary
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction. A logistic regression model was used for this analysis.
Time frame: Week 52
Population: All participants who received at least one dose of study drug and evaluable body weight data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg Tirzepatide | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 48.57 Percentage of participants |
| 15 mg Tirzepatide | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 72.06 Percentage of participants |
| Placebo | Percentage of Participants Who Achieve ≥15% Body Weight Reduction | 2.94 Percentage of participants |
p-value: <0.00195% CI: [6.68, 98.49]Regression, Logistic
p-value: <0.00195% CI: [17.69, 275.37]Regression, Logistic