Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight (NCT NCT04657003)
NCT ID: NCT04657003
Last Updated: 2024-04-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
938 participants
Primary outcome timeframe
Baseline, Week 72
Results posted on
2024-04-08
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received Placebo administered subcutaneously (SC) once weekly (QW).
|
10 Milligrams (mg) Tirzepatide
Participants received 10 mg Tirzepatide administered SC QW
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW
|
|---|---|---|---|
|
Overall Study
STARTED
|
315
|
312
|
311
|
|
Overall Study
Received at Least One Dose of Study Drug
|
315
|
312
|
311
|
|
Overall Study
COMPLETED
|
281
|
296
|
282
|
|
Overall Study
NOT COMPLETED
|
34
|
16
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Placebo administered subcutaneously (SC) once weekly (QW).
|
10 Milligrams (mg) Tirzepatide
Participants received 10 mg Tirzepatide administered SC QW
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
5
|
|
Overall Study
Death
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
10
|
|
Overall Study
Other - As Reported by Investigator
|
3
|
2
|
2
|
|
Overall Study
Pregnancy
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
16
|
7
|
10
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
Baseline characteristics by cohort
| Measure |
Placebo
n=315 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=312 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=311 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
Total
n=938 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10.5 • n=39 Participants
|
54.3 years
STANDARD_DEVIATION 10.7 • n=41 Participants
|
53.6 years
STANDARD_DEVIATION 10.6 • n=35 Participants
|
54.2 years
STANDARD_DEVIATION 10.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=39 Participants
|
158 Participants
n=41 Participants
|
159 Participants
n=35 Participants
|
476 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=39 Participants
|
154 Participants
n=41 Participants
|
152 Participants
n=35 Participants
|
462 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
188 Participants
n=39 Participants
|
184 Participants
n=41 Participants
|
189 Participants
n=35 Participants
|
561 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=39 Participants
|
124 Participants
n=41 Participants
|
112 Participants
n=35 Participants
|
358 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
42 Participants
n=35 Participants
|
125 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
77 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
248 Participants
n=39 Participants
|
228 Participants
n=41 Participants
|
234 Participants
n=35 Participants
|
710 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Argentina
|
116 Participants
n=39 Participants
|
115 Participants
n=41 Participants
|
115 Participants
n=35 Participants
|
346 Participants
n=31 Participants
|
|
Region of Enrollment
Brazil
|
30 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
89 Participants
n=31 Participants
|
|
Region of Enrollment
India
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
|
Region of Enrollment
Japan
|
21 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
67 Participants
n=31 Participants
|
|
Region of Enrollment
Russia
|
17 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
43 Participants
n=31 Participants
|
|
Region of Enrollment
Taiwan
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=39 Participants
|
114 Participants
n=41 Participants
|
114 Participants
n=35 Participants
|
342 Participants
n=31 Participants
|
|
Weight
|
101.65 kilograms (kg)
STANDARD_DEVIATION 22.26 • n=39 Participants
|
100.86 kilograms (kg)
STANDARD_DEVIATION 20.93 • n=41 Participants
|
99.60 kilograms (kg)
STANDARD_DEVIATION 20.05 • n=35 Participants
|
100.71 kilograms (kg)
STANDARD_DEVIATION 21.10 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 72Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Body Weight
|
-3.3 percent change
Standard Error 0.49
|
-13.4 percent change
Standard Error 0.48
|
-15.7 percent change
Standard Error 0.49
|
PRIMARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve ≥5% body weight reduction from baseline
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥5% Body Weight Reduction From Baseline
|
30.55 percentage of participants
|
81.55 percentage of participants
|
86.41 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve ≥10% body weight reduction from baseline
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥10% Body Weight Reduction From Baseline
|
8.68 percentage of participants
|
63.43 percentage of participants
|
69.58 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve ≥15% body weight reduction from baseline
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥15% Body Weight Reduction From Baseline
|
2.57 percentage of participants
|
41.42 percentage of participants
|
51.78 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve ≥20% body weight reduction from baseline
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥20% Body Weight Reduction From Baseline
|
0.96 percentage of participants
|
22.98 percentage of participants
|
33.98 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Absolute Body Weight
|
-3.2 kilograms (kg)
Standard Error 0.51
|
-13.5 kilograms (kg)
Standard Error 0.51
|
-15.6 kilograms (kg)
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI)
|
-1.2 kilograms per meter squared (kg/m^2)
Standard Error 0.19
|
-4.9 kilograms per meter squared (kg/m^2)
Standard Error 0.18
|
-5.7 kilograms per meter squared (kg/m^2)
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=290 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=301 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=300 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-0.16 percentage of HbA1c
Standard Error 0.067
|
-2.14 percentage of HbA1c
Standard Error 0.060
|
-2.22 percentage of HbA1c
Standard Error 0.060
|
SECONDARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve HbA1c \<7%
Outcome measures
| Measure |
Placebo
n=290 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=301 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=300 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve HbA1c <7%
|
29.31 percentage of participants
|
90.03 percentage of participants
|
90.67 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve HbA1c ≤6.5%
Outcome measures
| Measure |
Placebo
n=290 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=301 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=300 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve HbA1c ≤6.5%
|
15.52 percentage of participants
|
84.05 percentage of participants
|
86.67 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: 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.
Percentage of participants who achieve HbA1c \<5.7%
Outcome measures
| Measure |
Placebo
n=290 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=301 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=300 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve HbA1c <5.7%
|
2.76 percentage of participants
|
50.17 percentage of participants
|
55.33 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=290 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=300 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=300 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Fasting Glucose
|
-2.42 milligrams per deciliter (mg/dL)
Standard Error 2.281
|
-49.20 milligrams per deciliter (mg/dL)
Standard Error 1.940
|
-51.67 milligrams per deciliter (mg/dL)
Standard Error 1.970
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=309 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=309 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Waist Circumference
|
-3.4 centimeters (cm)
Standard Error 0.51
|
-11.2 centimeters (cm)
Standard Error 0.50
|
-13.8 centimeters (cm)
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and standard error (SE) from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=292 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=587 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
2.13 percent change
Standard Error 1.135
|
-2.58 percent change
Standard Error 0.755
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=292 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=587 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
6.29 percent change
Standard Error 1.874
|
2.72 percent change
Standard Error 1.264
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=292 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=587 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
1.10 percent change
Standard Error 1.048
|
8.19 percent change
Standard Error 0.782
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=284 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=574 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-6.0 percent change
Standard Error 2.18
|
-27.9 percent change
Standard Error 1.16
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=292 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=587 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
-5.8 percent change
Standard Error 2.32
|
-28.6 percent change
Standard Error 1.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=292 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=587 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Tirzepatide 10 mg and 15 mg)
|
2.30 percent change
Standard Error 1.573
|
-6.64 percent change
Standard Error 1.001
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=291 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=586 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of 10 mg and 15 mg Tirzepatide)
|
0.03 percent change
Standard Error 2.838
|
-23.58 percent change
Standard Error 1.502
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
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).
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=618 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)
|
-1.0 millimeters of mercury (mmHg)
Standard Error 0.74
|
-7.2 millimeters of mercury (mmHg)
Standard Error 0.52
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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).
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).
Outcome measures
| Measure |
Placebo
n=311 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=618 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of 10 mg and 15 mg Tirzepatide)
|
-0.2 millimeters of mercury (mmHg)
Standard Error 0.45
|
-2.6 millimeters of mercury (mmHg)
Standard Error 0.31
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Outcome measures
| Measure |
Placebo
n=247 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=282 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=280 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Insulin
|
-14.5 percent change
Standard Error 3.39
|
-29.6 percent change
Standard Error 2.28
|
-40.3 percent change
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=270 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=281 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=270 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
|
1.6 score on a scale
Standard Error 0.40
|
3.4 score on a scale
Standard Error 0.39
|
3.8 score on a scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=270 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=282 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=269 Participants
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score
|
7.4 score on a scale
Standard Error 1.03
|
14.3 score on a scale
Standard Error 1.00
|
15.2 score on a scale
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Week 8, 16, 36: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
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.
Outcome measures
| Measure |
Placebo
n=308 Participants
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=308 Participants
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide
|
153000 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 19.5
|
234000 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 19.2
|
—
|
Adverse Events
Placebo
Serious events: 23 serious events
Other events: 158 other events
Deaths: 0 deaths
10 mg Tirzepatide
Serious events: 18 serious events
Other events: 169 other events
Deaths: 2 deaths
15 mg Tirzepatide
Serious events: 27 serious events
Other events: 159 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=315 participants at risk
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=312 participants at risk
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=311 participants at risk
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 3 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.64%
2/311 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.63%
2/315 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.64%
2/311 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.64%
2/311 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis perforated
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.64%
2/311 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.63%
2/315 • Number of events 3 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gangrene
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.64%
2/312 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/159 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/158 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.63%
1/159 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/156 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/154 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.66%
1/152 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.64%
2/311 • Number of events 2 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.96%
3/312 • Number of events 3 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Calculus bladder
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/159 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.63%
1/158 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/159 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.32%
1/315 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/312 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/311 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/315 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
1/312 • Number of events 1 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/311 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=315 participants at risk
Participants received Placebo administered SC QW.
|
10 mg Tirzepatide
n=312 participants at risk
Participants received 10 mg Tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=311 participants at risk
Participants received 15 mg Tirzepatide administered SC QW.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
7/315 • Number of events 17 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
12/312 • Number of events 16 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
23/311 • Number of events 31 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
13/315 • Number of events 16 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.0%
25/312 • Number of events 31 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.0%
28/311 • Number of events 40 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.9%
28/315 • Number of events 40 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
19.9%
62/312 • Number of events 127 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.2%
66/311 • Number of events 180 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
10/315 • Number of events 14 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
23/312 • Number of events 30 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
22/311 • Number of events 50 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.63%
2/315 • Number of events 3 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
19/312 • Number of events 31 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
13/311 • Number of events 23 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
20/315 • Number of events 23 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.2%
63/312 • Number of events 250 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.9%
68/311 • Number of events 157 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
10/315 • Number of events 13 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.9%
34/312 • Number of events 56 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.9%
40/311 • Number of events 60 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
16.8%
53/315 • Number of events 55 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
52/312 • Number of events 55 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.6%
33/311 • Number of events 33 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
17/315 • Number of events 22 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.9%
9/312 • Number of events 10 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
10/311 • Number of events 12 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
21/315 • Number of events 28 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
10/312 • Number of events 16 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.9%
12/311 • Number of events 14 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
7/315 • Number of events 7 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
30/312 • Number of events 32 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
31/311 • Number of events 40 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
45/315 • Number of events 46 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
6/312 • Number of events 6 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.3%
4/311 • Number of events 4 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
1.6%
5/315 • Number of events 5 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.4%
17/312 • Number of events 19 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
8/311 • Number of events 10 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
2.9%
9/315 • Number of events 14 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.1%
16/312 • Number of events 27 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
15/311 • Number of events 17 • Baseline through Week 76
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60