Trial Outcomes & Findings for A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (NCT NCT05260021)
NCT ID: NCT05260021
Last Updated: 2025-09-26
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 determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
Baseline, Week 30
Results posted on
2025-09-26
Participant Flow
Participant milestones
| Measure |
5 Milligram (mg) Tirzepatide/5 mg Tirzepatide
Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up.
|
10 mg Tirzepatide/10 mg Tirzepatide
Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up.
|
Placebo/5 mg Tirzepatide
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.
|
|---|---|---|---|
|
Double-blind Period (30 Weeks)
STARTED
|
32
|
33
|
34
|
|
Double-blind Period (30 Weeks)
Received Atleast One Dose of Study Drug
|
32
|
33
|
34
|
|
Double-blind Period (30 Weeks)
Safety Analysis Set 1
|
32
|
33
|
34
|
|
Double-blind Period (30 Weeks)
COMPLETED
|
29
|
29
|
32
|
|
Double-blind Period (30 Weeks)
NOT COMPLETED
|
3
|
4
|
2
|
|
Open-label Period (22 Weeks)
STARTED
|
29
|
29
|
32
|
|
Open-label Period (22 Weeks)
Safety Analysis Set 2
|
32
|
33
|
32
|
|
Open-label Period (22 Weeks)
COMPLETED
|
29
|
29
|
32
|
|
Open-label Period (22 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Safety Follow-up Period (4 Weeks)
STARTED
|
29
|
29
|
32
|
|
Safety Follow-up Period (4 Weeks)
COMPLETED
|
29
|
29
|
32
|
|
Safety Follow-up Period (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
5 Milligram (mg) Tirzepatide/5 mg Tirzepatide
Participants received 5 mg Tirzepatide once weekly (QW) administered as subcutaneous (SC) injection via single-dose pen (SDP) for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up.
|
10 mg Tirzepatide/10 mg Tirzepatide
Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period and 22 weeks in open-label period with an additional 4 weeks of safety follow-up.
|
Placebo/5 mg Tirzepatide
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period and 5 mg Tirzepatide QW administered as SC injection via SDP for 22 weeks in open-label period.
|
|---|---|---|---|
|
Double-blind Period (30 Weeks)
Adverse Event
|
2
|
0
|
0
|
|
Double-blind Period (30 Weeks)
Withdrawal by Subject
|
1
|
2
|
1
|
|
Double-blind Period (30 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
|
Double-blind Period (30 Weeks)
Withdrawal due to Caregiver Circumstances
|
0
|
1
|
0
|
|
Double-blind Period (30 Weeks)
Incorrectly Enrolled
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=32 Participants
Participants received 5 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
10 mg Tirzepatide
n=33 Participants
Participants received 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.00 years
STANDARD_DEVIATION 1.93 • n=5 Participants
|
14.60 years
STANDARD_DEVIATION 1.83 • n=7 Participants
|
14.60 years
STANDARD_DEVIATION 1.79 • n=5 Participants
|
14.70 years
STANDARD_DEVIATION 1.84 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
India
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Hemoglobin A1c
|
8.22 Percentage of HbA1c
STANDARD_DEVIATION 1.17 • n=5 Participants
|
7.89 Percentage of HbA1c
STANDARD_DEVIATION 1.22 • n=7 Participants
|
8.02 Percentage of HbA1c
STANDARD_DEVIATION 1.30 • n=5 Participants
|
8.04 Percentage of HbA1c
STANDARD_DEVIATION 1.23 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.This analysis was planned to measure the outcome by combining the 5 mg tirzepatide treatment arm and 10 mg tirzepatide treatment arm as pooled doses of tirzepatide (5 mg/10 mg).
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 determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=56 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=32 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg and 10 mg)
|
-2.03 percentage of HbA1c
Standard Error 0.165
|
-0.23 percentage of HbA1c
Standard Error 0.229
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic 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 determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=27 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=32 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c (Individual Doses)
|
-1.90 percentage of HbA1c
Standard Error 0.236
|
-2.16 percentage of HbA1c
Standard Error 0.232
|
-0.23 percentage of HbA1c
Standard Error 0.229
|
—
|
SECONDARY outcome
Timeframe: Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=32 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=33 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=65 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve ≤6.5% of HbA1c
|
66.4 percentage of participants
|
80.6 percentage of participants
|
73.6 percentage of participants
|
28.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to the study intervention or initiation of rescue antihyperglycemic medication.
BMI SDS (age and sex matched), calculated using the World Health Organization (WHO) growth reference standards. BMI is calculated as weight in kilograms divided by height in meters squared (kg/m²) and converted to a Z-score (SDS) based on WHO reference data. A Z-score of 0 represents the population mean for a given age and sex. A BMI SDS between -1 and +1 is considered normal. Obesity is defined as BMI SDS \> +2. Reductions in BMI SDS indicate improvement in weight status for individuals with obesity. LS mean was determined by the ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=29 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=58 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched)
|
-0.45 Z-score
Standard Error 0.072
|
-0.76 Z-score
Standard Error 0.072
|
-0.60 Z-score
Standard Error 0.050
|
-0.09 Z-score
Standard Error 0.069
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=28 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=28 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=56 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=33 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG)
|
-35.5 milligram per deciliter (mg/dL)
Standard Error 7.76
|
-50.6 milligram per deciliter (mg/dL)
Standard Error 7.40
|
-43.0 milligram per deciliter (mg/dL)
Standard Error 5.42
|
-6.6 milligram per deciliter (mg/dL)
Standard Error 7.36
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares).
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=29 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=58 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in BMI
|
-6.73 Percent Change of BMI
Standard Error 1.155
|
-11.07 Percent Change of BMI
Standard Error 1.154
|
-8.90 Percent Change of BMI
Standard Error 0.808
|
-0.55 Percent Change of BMI
Standard Error 1.107
|
SECONDARY outcome
Timeframe: Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=32 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=33 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=65 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve <5.7% of HbA1c
|
44.1 percentage of participants
|
56.2 percentage of participants
|
50.2 percentage of participants
|
15.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to the study intervention or initiation of rescue antihyperglycemic medication.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=32 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=33 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=65 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve <7.0% of HbA1c
|
79.6 percentage of participants
|
84.5 percentage of participants
|
82.1 percentage of participants
|
37.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
Geometric LS mean was determined by the MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline Antihyperglycemic medication + Baseline Age group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=27 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=28 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=55 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=32 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Serum Lipid Levels
Serum Cholesterol
|
-8.07 Percent change of Serum Lipid Levels
Standard Error 2.319
|
-13.82 Percent change of Serum Lipid Levels
Standard Error 2.115
|
-10.99 Percent change of Serum Lipid Levels
Standard Error 1.564
|
5.07 Percent change of Serum Lipid Levels
Standard Error 2.456
|
|
Percent Change From Baseline for Serum Lipid Levels
Serum High-density lipoprotein (HDL) Cholesterol 3RD generation, enzymatic
|
5.56 Percent change of Serum Lipid Levels
Standard Error 3.269
|
1.72 Percent change of Serum Lipid Levels
Standard Error 3.087
|
3.62 Percent change of Serum Lipid Levels
Standard Error 2.247
|
0.92 Percent change of Serum Lipid Levels
Standard Error 2.887
|
|
Percent Change From Baseline for Serum Lipid Levels
Serum Triglycerides
|
-27.6 Percent change of Serum Lipid Levels
Standard Error 4.816
|
-35.8 Percent change of Serum Lipid Levels
Standard Error 4.165
|
-31.8 Percent change of Serum Lipid Levels
Standard Error 3.165
|
-1.74 Percent change of Serum Lipid Levels
Standard Error 6.022
|
|
Percent Change From Baseline for Serum Lipid Levels
Serum low-density lipoprotein (LDL) Cholesterol Combined
|
-6.08 Percent change of Serum Lipid Levels
Standard Error 3.870
|
-11.97 Percent change of Serum Lipid Levels
Standard Error 3.540
|
-9.07 Percent change of Serum Lipid Levels
Standard Error 2.618
|
9.84 Percent change of Serum Lipid Levels
Standard Error 4.185
|
|
Percent Change From Baseline for Serum Lipid Levels
Serum very low-density lipoprotein (VLDL) Cholesterol Combined
|
-25.9 Percent change of Serum Lipid Levels
Standard Error 5.005
|
-34.8 Percent change of Serum Lipid Levels
Standard Error 4.293
|
-30.5 Percent change of Serum Lipid Levels
Standard Error 3.276
|
-0.26 Percent change of Serum Lipid Levels
Standard Error 6.211
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
Height SDS (age and sex-matched), calculated using the World Health Organization (WHO) growth reference standards. Height SDS is derived by comparing a child's height to the median height for their age and sex in the WHO reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean. A Height SDS below -2 indicates short stature. Positive changes in Height SDS from baseline reflect improvement in growth velocity or catch-up growth. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + 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 |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=29 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=58 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in Height Standard Deviation Score (SDS)
|
-0.092 Z-score
Standard Error 0.0275
|
-0.11 Z-score
Standard Error 0.0274
|
-0.100 Z-score
Standard Error 0.0194
|
-0.11 Z-score
Standard Error 0.0259
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
Weight SDS, calculated using Centers for Disease Control and Prevention (CDC) growth reference standards. Weight SDS is derived by comparing a child's weight to median weight for their age and sex in the CDC reference population, then expressing the difference in standard deviation units (Z-scores). A Z-score of 0 represents the population mean for a given age and sex. A Weight SDS below -2 may indicate underweight status, while a Weight SDS above +2 may indicate overweight or obesity. Change from baseline Weight SDS reflects shifts in growth trajectory, with positive changes indicating weight gain and negative changes indicating weight reduction. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Age group + Baseline Antihyperglycemic medication + 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 |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=29 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=58 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=34 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in Weight SDS
|
-0.38 Z-score
Standard Error 0.0600
|
-0.50 Z-score
Standard Error 0.0594
|
-0.44 Z-score
Standard Error 0.0422
|
-0.099 Z-score
Standard Error 0.0570
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind, open-label, and safety follow-up periods regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children (ages 8 to 12) and teenagers (ages 13 to 18). The 23-item PedsQL Generic Core Scale includes physical, emotional, social, and school functioning dimensions. The PedsQL Generic Core yields two summary scores: Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning. Each item is scored from 0 (never) to 4 (almost always). Items are reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best). Higher scores indicate better health-related quality of life. LS mean was determined by the MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic Medication + Baseline Age Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured.
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=27 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=25 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=56 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Physical Functioning Score
|
4.26 score on a scale
Standard Error 2.034
|
3.06 score on a scale
Standard Error 2.092
|
5.03 score on a scale
Standard Error 2.142
|
3.66 score on a scale
Standard Error 1.456
|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Emotional Functioning Score
|
4.35 score on a scale
Standard Error 3.506
|
4.11 score on a scale
Standard Error 3.601
|
6.78 score on a scale
Standard Error 3.705
|
4.23 score on a scale
Standard Error 2.514
|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Social Functioning Score
|
4.16 score on a scale
Standard Error 2.628
|
3.00 score on a scale
Standard Error 2.696
|
4.54 score on a scale
Standard Error 2.764
|
3.58 score on a scale
Standard Error 1.878
|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
School Functioning Score
|
13.30 score on a scale
Standard Error 3.095
|
0.18 score on a scale
Standard Error 3.152
|
12.03 score on a scale
Standard Error 3.239
|
6.74 score on a scale
Standard Error 2.197
|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Psychosocial Health Summary Score
|
7.82 score on a scale
Standard Error 2.482
|
2.20 score on a scale
Standard Error 2.533
|
7.47 score on a scale
Standard Error 2.605
|
5.01 score on a scale
Standard Error 1.767
|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Physical Health Summary Score
|
4.26 score on a scale
Standard Error 2.034
|
3.06 score on a scale
Standard Error 2.092
|
5.03 score on a scale
Standard Error 2.142
|
3.66 score on a scale
Standard Error 1.456
|
|
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
Total Score
|
6.65 score on a scale
Standard Error 2.114
|
2.45 score on a scale
Standard Error 2.163
|
6.61 score on a scale
Standard Error 2.220
|
4.55 score on a scale
Standard Error 1.507
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had evaluable data for this outcome obtained during the double-blind, open-label, and safety follow-up periods regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
The PedsQL 3.2 Diabetes Module has 33 items for ages 13 years and older, and 32 items (1 less item for the Worry Scale) for ages 2 to 12 years. The 5 dimensions consist of diabetes symptoms (15 items), treatment barriers (5 items), treatment adherence (6 items), worry \[2 items (3 for teens and adults)\] and communication (4 items). Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores reflect fewer problems and better functioning. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + 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 |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=29 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=27 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=25 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=56 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Change From Baseline PedsQL (3.2) Diabetic Module
Diabetes Management Summary Score
|
7.21 score on a scale
Standard Error 2.669
|
8.60 score on a scale
Standard Error 2.733
|
5.25 score on a scale
Standard Error 2.872
|
7.90 score on a scale
Standard Error 1.907
|
|
Change From Baseline PedsQL (3.2) Diabetic Module
Total Score
|
8.79 score on a scale
Standard Error 2.310
|
8.74 score on a scale
Standard Error 2.374
|
6.03 score on a scale
Standard Error 2.489
|
8.76 score on a scale
Standard Error 1.657
|
SECONDARY outcome
Timeframe: Week 0: after the first dose anytime on the same day. Weeks 7, 16, and 29: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post-dose, as assigned by IWRS.Population: All randomized participants who received at least one dose of study drug and had evaluable PK data obtained during the double-blind period regardless of adherence to study intervention or initiation of rescue antihyperglycemic medication.
The steady-state AUCs were estimated from Tirzepatide concentrations at Weeks 0, 7, 16, and 29 using the population PK model by treatment group.
Outcome measures
| Measure |
Pooled Doses of Tirzepatide (5 mg, 10 mg)
n=32 Participants
Participants received either 5 mg or 10 mg Tirzepatide QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
n=31 Participants
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
Placebo
Participants received placebo QW administered as SC injection via SDP for 30 weeks in double-blind period.
|
|---|---|---|---|---|
|
Population Pharmacokinetics (PopPK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide
|
92100 nanogram*hour per milliliter (ng*hr/mL)
Interval 85700.0 to 98600.0
|
184000 nanogram*hour per milliliter (ng*hr/mL)
Interval 171000.0 to 197000.0
|
—
|
—
|
Adverse Events
5 mg Tirzepatide / Double-Blind Period
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
TZP 10mg / Double-Blind Period
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo / Double-Blind Period
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
TZP 5mg / 5mg Open-Label and Safety Follow-Up Period
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
TZP 10mg / 10mg Open-Label and Safety Follow-Up Period
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo/TZP 5mg Open-Label and Safety Follow-Up Period
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Tirzepatide / Double-Blind Period
n=32 participants at risk
Participants received 5 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.
|
TZP 10mg / Double-Blind Period
n=33 participants at risk
Participants received 10 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.
|
Placebo / Double-Blind Period
n=34 participants at risk
Participants received placebo QW administered as SC injection via SDP for 30 weeks in a double-blind period.
|
TZP 5mg / 5mg Open-Label and Safety Follow-Up Period
n=32 participants at risk
Participants who received 5 mg tirzepatide during the double-blind period continued to receive 5 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.
|
TZP 10mg / 10mg Open-Label and Safety Follow-Up Period
n=33 participants at risk
Participants who received 10 mg of tirzepatide during the double-blind period continued to receive 10 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.
|
Placebo/TZP 5mg Open-Label and Safety Follow-Up Period
n=32 participants at risk
Participants who received placebo QW during the double-blind period were switched to 5 mg tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
Other adverse events
| Measure |
5 mg Tirzepatide / Double-Blind Period
n=32 participants at risk
Participants received 5 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.
|
TZP 10mg / Double-Blind Period
n=33 participants at risk
Participants received 10 mg of tirzepatide QW administered as SC injection via SDP for 30 weeks in a double-blind period.
|
Placebo / Double-Blind Period
n=34 participants at risk
Participants received placebo QW administered as SC injection via SDP for 30 weeks in a double-blind period.
|
TZP 5mg / 5mg Open-Label and Safety Follow-Up Period
n=32 participants at risk
Participants who received 5 mg tirzepatide during the double-blind period continued to receive 5 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.
|
TZP 10mg / 10mg Open-Label and Safety Follow-Up Period
n=33 participants at risk
Participants who received 10 mg of tirzepatide during the double-blind period continued to receive 10 mg of tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.
|
Placebo/TZP 5mg Open-Label and Safety Follow-Up Period
n=32 participants at risk
Participants who received placebo QW during the double-blind period were switched to 5 mg tirzepatide QW administered as SC injection via SDP for 22 weeks in the open-label period and 4 weeks in the safety follow-up period.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 7 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
9.1%
3/33 • Number of events 5 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
9.4%
3/32 • Number of events 4 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.6%
5/32 • Number of events 5 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • Number of events 18 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
12.1%
4/33 • Number of events 4 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
8.8%
3/34 • Number of events 4 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
8/32 • Number of events 23 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
24.2%
8/33 • Number of events 11 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
5.9%
2/34 • Number of events 7 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
15.6%
5/32 • Number of events 6 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
18.8%
6/32 • Number of events 13 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
12.1%
4/33 • Number of events 5 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Nausea
|
21.9%
7/32 • Number of events 27 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
18.2%
6/33 • Number of events 7 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
8.8%
3/34 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
5/32 • Number of events 7 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
12.1%
4/33 • Number of events 24 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.1%
2/33 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.1%
1/32 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
General disorders
Injection site reaction
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.1%
2/33 • Number of events 6 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
5.9%
2/34 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.1%
2/33 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
5.9%
2/34 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
9.1%
3/33 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Infections and infestations
Tonsillitis
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
12.1%
4/33 • Number of events 5 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
14.7%
5/34 • Number of events 5 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.1%
2/33 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 4 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
2.9%
1/34 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.4%
3/32 • Number of events 4 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
5.9%
2/34 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 3 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
General disorders
Pyrexia
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.0%
1/33 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/34 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
3.1%
1/32 • Number of events 1 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/33 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
6.2%
2/32 • Number of events 2 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/21 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/18 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/21 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
9.5%
2/21 • Number of events 8 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/18 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
0.00%
0/20 • Baseline Up to Week 56
All randomised participants who received at least one dose of study drug were included in safety analyses, regardless of adherence or use of rescue medication. Gender-specific events reflect adjusted at-risk counts. Per analysis plan, adverse events were reported for all mITT participants by randomized arms; for the double-blind period using safety analysis set 1; and for overall study using Safety Analysis Set 2, with combined data from Double blind, Open-Label and Safety Follow-Up Periods.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60