Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (NCT NCT05691712)
NCT ID: NCT05691712
Last Updated: 2025-08-08
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
257 participants
Primary outcome timeframe
Baseline, Week 40
Results posted on
2025-08-08
Participant Flow
Participant milestones
| Measure |
5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
63
|
64
|
|
Overall Study
Received at Least One Dose of Study Drug
|
65
|
65
|
63
|
64
|
|
Overall Study
COMPLETED
|
61
|
60
|
58
|
61
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
5
|
3
|
Reasons for withdrawal
| Measure |
5 Milligram (mg) Tirzepatide
Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Assigned Treatment by Mistake
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=65 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
n=65 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=63 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=64 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.10 years
STANDARD_DEVIATION 9.97 • n=5 Participants
|
55.00 years
STANDARD_DEVIATION 11.58 • n=7 Participants
|
55.80 years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
58.00 years
STANDARD_DEVIATION 10.24 • n=4 Participants
|
56.70 years
STANDARD_DEVIATION 10.53 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
257 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
257 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
China
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
257 Participants
n=21 Participants
|
|
Percentage of Hemoglobin A1c (HbA1c) at Baseline
|
8.64 Percentage of HbA1c
STANDARD_DEVIATION 0.95 • n=5 Participants
|
8.60 Percentage of HbA1c
STANDARD_DEVIATION 1.09 • n=7 Participants
|
8.75 Percentage of HbA1c
STANDARD_DEVIATION 0.99 • n=5 Participants
|
8.84 Percentage of HbA1c
STANDARD_DEVIATION 0.99 • n=4 Participants
|
8.71 Percentage of HbA1c
STANDARD_DEVIATION 1.01 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Outcome measures
| Measure |
10 mg Tirzepatide
n=55 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=58 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=57 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])
|
-25.9 millimoles per mole (mmol/mol)
Standard Error 1.386
|
-9.96 millimoles per mole (mmol/mol)
Standard Error 1.340
|
—
|
-26.1 millimoles per mole (mmol/mol)
Standard Error 1.367
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Outcome measures
| Measure |
10 mg Tirzepatide
n=58 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)
|
-9.96 mmol/mol
Standard Error 1.340
|
—
|
—
|
-23.0 mmol/mol
Standard Error 1.329
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight
|
-4.8 kilograms (kg)
Standard Error 0.54
|
-4.3 kilograms (kg)
Standard Error 0.55
|
1.7 kilograms (kg)
Standard Error 0.53
|
-2.7 kilograms (kg)
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of Participants with HbA1c \<7.0% (53 millimole/mole \[mmol/mol\]) and ≤6.5% (48 mmol/mol) is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)
HbA1c <7.0%
|
78.95 percentage of participants
|
78.18 percentage of participants
|
17.24 percentage of participants
|
75.81 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)
HbA1c ≤6.5%
|
77.19 percentage of participants
|
69.09 percentage of participants
|
6.90 percentage of participants
|
59.68 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Fasting Serum Glucose
|
-52.5 milligram per deciliter (mg/dL)
Standard Error 3.87
|
-51.0 milligram per deciliter (mg/dL)
Standard Error 3.94
|
-23.7 milligram per deciliter (mg/dL)
Standard Error 3.84
|
-45.5 milligram per deciliter (mg/dL)
Standard Error 3.73
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \<5.7% (39 mmol/Mol) is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=55 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=58 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=57 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]
|
25.45 percentage of participants
|
0.00 percentage of participants
|
—
|
17.54 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \<5.7% (39 mmol/Mol) is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=58 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]
|
0.00 percentage of participants
|
—
|
—
|
9.68 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=63 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Morning Premeal - Fasting
|
-2.53 millimoles per liter per day(mmol/L/day)
Standard Error 0.132
|
-2.80 millimoles per liter per day(mmol/L/day)
Standard Error 0.136
|
-2.22 millimoles per liter per day(mmol/L/day)
Standard Error 0.131
|
-2.62 millimoles per liter per day(mmol/L/day)
Standard Error 0.127
|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Morning 2-hour Postmeal
|
-5.34 millimoles per liter per day(mmol/L/day)
Standard Error 0.306
|
-5.05 millimoles per liter per day(mmol/L/day)
Standard Error 0.313
|
-2.57 millimoles per liter per day(mmol/L/day)
Standard Error 0.300
|
-4.78 millimoles per liter per day(mmol/L/day)
Standard Error 0.300
|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Midday Premeal
|
-3.52 millimoles per liter per day(mmol/L/day)
Standard Error 0.258
|
-3.26 millimoles per liter per day(mmol/L/day)
Standard Error 0.263
|
-1.32 millimoles per liter per day(mmol/L/day)
Standard Error 0.253
|
-2.87 millimoles per liter per day(mmol/L/day)
Standard Error 0.247
|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Midday 2-hour Postmeal
|
-4.10 millimoles per liter per day(mmol/L/day)
Standard Error 0.325
|
-3.65 millimoles per liter per day(mmol/L/day)
Standard Error 0.335
|
-1.46 millimoles per liter per day(mmol/L/day)
Standard Error 0.322
|
-4.05 millimoles per liter per day(mmol/L/day)
Standard Error 0.318
|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Evening Premeal
|
-3.64 millimoles per liter per day(mmol/L/day)
Standard Error 0.276
|
-3.20 millimoles per liter per day(mmol/L/day)
Standard Error 0.285
|
-0.95 millimoles per liter per day(mmol/L/day)
Standard Error 0.271
|
-2.84 millimoles per liter per day(mmol/L/day)
Standard Error 0.264
|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Evening 2-hour Postmeal
|
-4.52 millimoles per liter per day(mmol/L/day)
Standard Error 0.351
|
-4.42 millimoles per liter per day(mmol/L/day)
Standard Error 0.367
|
-1.47 millimoles per liter per day(mmol/L/day)
Standard Error 0.346
|
-3.97 millimoles per liter per day(mmol/L/day)
Standard Error 0.347
|
|
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Bedtime
|
-4.19 millimoles per liter per day(mmol/L/day)
Standard Error 0.297
|
-3.85 millimoles per liter per day(mmol/L/day)
Standard Error 0.307
|
-1.71 millimoles per liter per day(mmol/L/day)
Standard Error 0.298
|
-3.41 millimoles per liter per day(mmol/L/day)
Standard Error 0.287
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss of ≥5%
|
49.12 percentage of participants
|
60.00 percentage of participants
|
1.72 percentage of participants
|
25.81 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss of ≥10%
|
21.05 percentage of participants
|
25.45 percentage of participants
|
0.00 percentage of participants
|
8.06 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Weight Loss of ≥15%
|
5.26 percentage of participants
|
9.09 percentage of participants
|
0.00 percentage of participants
|
4.84 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Daily Mean Insulin Glargine Dose
|
21.95 percent change
Standard Error 6.471
|
18.21 percent change
Standard Error 6.364
|
69.28 percent change
Standard Error 8.826
|
23.90 percent change
Standard Error 6.424
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants with HbA1c \<7.0%, Without Weight Gain (\<0.1 Kilogram \[kg\]) and Without Hypoglycemia, (Blood Glucose \<3.0 mmol/L \<54 Milligram/Deciliter \[mg/dL\]) is reported here
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL])
|
70.18 percentage of participants
|
67.27 percentage of participants
|
5.17 percentage of participants
|
59.68 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \<0.1 kg and Without Hypoglycemia (Blood glucose \<3.0 mmol/L \[54 mg/dL\]) is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL])
|
70.18 percentage of participants
|
61.82 percentage of participants
|
1.72 percentage of participants
|
46.77 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants with HbA1c \<7.0%, Without Weight Gain \<0.1 kg and Without Hypoglycemia (Blood Glucose \<3.9 mmol/L \[70 mg/dL\] or Severe Hypoglycemia) is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)
|
57.89 percentage of participants
|
47.27 percentage of participants
|
5.17 percentage of participants
|
51.61 percentage of participants
|
SECONDARY outcome
Timeframe: Week 40Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.
Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \<0.1 kg and Without Hypoglycemia (Blood glucose \<3.9 mmol/L \[70 mg/dL\] or Severe Hypoglycemia) is reported here.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=55 Participants
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=58 Participants
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
5 mg Tirzepatide
n=62 Participants
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
|---|---|---|---|---|
|
Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)
|
57.89 percentage of participants
|
43.64 percentage of participants
|
1.72 percentage of participants
|
38.71 percentage of participants
|
Adverse Events
5 mg Tirzepatide
Serious events: 8 serious events
Other events: 45 other events
Deaths: 1 deaths
10 mg Tirzepatide
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
15 mg Tirzepatide
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Tirzepatide
n=65 participants at risk
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
n=65 participants at risk
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=63 participants at risk
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=64 participants at risk
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
1.5%
1/65 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Diabetic retinopathy
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye disorder
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Vitreous haemorrhage
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Mass
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Sudden death
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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 injury
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Upper limb fracture
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Gouty arthritis
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Periarthritis
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Rotator cuff syndrome
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Spinal osteoarthritis
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Synovitis
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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)
Colorectal adenoma
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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)
Oesophageal carcinoma
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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)
Small cell lung cancer
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Ovarian cyst
|
0.00%
0/23 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
1/26 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
5 mg Tirzepatide
n=65 participants at risk
Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
|
10 mg Tirzepatide
n=65 participants at risk
Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
|
15 mg Tirzepatide
n=63 participants at risk
Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks.
The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
|
Placebo
n=64 participants at risk
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/65 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.8%
7/65 • Number of events 7 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
3/65 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
4/63 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/65 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/65 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.2%
17/65 • Number of events 61 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
36.9%
24/65 • Number of events 45 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
36.5%
23/63 • Number of events 44 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
5/64 • Number of events 10 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
4/65 • Number of events 7 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
4.6%
3/65 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.8%
7/65 • Number of events 8 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
7/63 • Number of events 13 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
4.6%
3/65 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/65 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/64 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/65 • Number of events 7 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.2%
6/65 • Number of events 7 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
4/63 • Number of events 20 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/65 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
|
20.0%
13/65 • Number of events 17 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.9%
11/65 • Number of events 14 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.5%
11/63 • Number of events 12 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.1%
9/64 • Number of events 11 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
6.2%
4/65 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.3%
8/65 • Number of events 11 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
3/63 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/64 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
2/65 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/65 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
18.5%
12/65 • Number of events 15 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.5%
14/65 • Number of events 19 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
6/63 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
|
29.2%
19/65 • Number of events 23 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
24.6%
16/65 • Number of events 22 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
31.7%
20/63 • Number of events 33 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
3.1%
2/65 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
5/65 • Number of events 5 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
3/63 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.2%
4/65 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.6%
3/65 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.5%
6/63 • Number of events 6 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
4.6%
3/65 • Number of events 3 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/65 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/64 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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
Benign prostatic hyperplasia
|
4.8%
2/42 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
2/40 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/37 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
2/65 • Number of events 2 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/65 • Number of events 1 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Baseline up to week 44
All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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