Trial Outcomes & Findings for A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus (NCT NCT04235959)
NCT ID: NCT04235959
Last Updated: 2023-07-06
Results Overview
The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline up to 43 Weeks
Results posted on
2023-07-06
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo once weekly (QW) subcutaneously (SC).
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
10
|
|
Overall Study
Received At Least One Dose of Study Drug
|
4
|
10
|
10
|
|
Overall Study
COMPLETED
|
3
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once weekly (QW) subcutaneously (SC).
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
n=10 Participants
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
n=10 Participants
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
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
China
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 43 WeeksPopulation: All participants who received at least one dose of study drug.
The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
n=10 Participants
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
n=10 Participants
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).Population: All participants who received at least one dose of tirzepatide and had evaluable PK data in Cohort 1.
PK: AUC \[0-168\] of Tirzepatide.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)
Week 0
|
35100 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
—
|
—
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)
Week 7
|
125000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
—
|
—
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)
Week 15
|
263000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 17
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).Population: All participants who received at least one dose of tirzepatide and had evaluable PK data in Cohort 2.
PK: AUC \[0-168\] of Tirzepatide.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
PK: AUC [0-168] of Tirzepatide (Cohort 2)
Week 0
|
30900 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
—
|
—
|
|
PK: AUC [0-168] of Tirzepatide (Cohort 2)
Week 7
|
110000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
—
|
—
|
|
PK: AUC [0-168] of Tirzepatide (Cohort 2)
Week 23
|
357000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).Population: All participants who received at least one dose of tirzepatide and had evaluable PK data in Cohort 1.
PK: Cmax of Tirzepatide.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)
Week 0
|
306 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
|
PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)
Week 7
|
1030 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
—
|
—
|
|
PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)
Week 15
|
2200 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 16
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).Population: All participants who received at least one dose of tirzepatide and had evaluable PK data in Cohort 2.
PK: Cmax of Tirzepatide.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
PK: Cmax of Tirzepatide (Cohort 2)
Week 0
|
257 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
—
|
—
|
|
PK: Cmax of Tirzepatide (Cohort 2)
Week 7
|
915 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
—
|
—
|
|
PK: Cmax of Tirzepatide (Cohort 2)
Week 23
|
2930 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2 (2.5 to 15 mg Tirzepatide)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=4 participants at risk
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
n=10 participants at risk
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
n=10 participants at risk
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Participants received placebo QW SC.
|
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)
n=10 participants at risk
Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15.
|
Cohort 2 (2.5 to 15 mg Tirzepatide)
n=10 participants at risk
Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.
|
|---|---|---|---|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Cardiac disorders
Coronary artery disease
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
20.0%
2/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
50.0%
5/10 • Number of events 6 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
60.0%
6/10 • Number of events 17 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
40.0%
4/10 • Number of events 5 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
40.0%
4/10 • Number of events 4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Tooth loss
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
20.0%
2/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
20.0%
2/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
20.0%
2/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
2/4 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
20.0%
2/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Electrocardiogram qt prolonged
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Electrocardiogram t wave abnormal
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
30.0%
3/10 • Number of events 5 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Occult blood positive
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
50.0%
5/10 • Number of events 7 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
80.0%
8/10 • Number of events 9 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
75.0%
3/4 • Number of events 5 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
50.0%
5/10 • Number of events 6 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
20.0%
2/10 • Number of events 3 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Renal and urinary disorders
Renal failure
|
25.0%
1/4 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 2 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
0.00%
0/10 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
10.0%
1/10 • Number of events 1 • Up To 43 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60