Trial Outcomes & Findings for A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia (NCT NCT06173570)
NCT ID: NCT06173570
Last Updated: 2025-11-17
Results Overview
Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C \* 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
COMPLETED
PHASE2
428 participants
From first day of treatment up to week 12
2025-11-17
Participant Flow
The study was conducted from January 2024 to September 2024 in 55 research sites in 8 countries (United States, Canada, Czech Republic, Denmark, Hungary, Japan, Slovakia, and Spain).
Of 428 enrolled participants, two randomized participants - one screen failure and one withdrawal by subject - did not start treatment.
Participant milestones
| Measure |
AZD0780 1 mg
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
85
|
85
|
85
|
87
|
|
Overall Study
Started Treatment
|
86
|
85
|
84
|
85
|
86
|
|
Overall Study
COMPLETED
|
81
|
81
|
84
|
80
|
82
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
1
|
5
|
5
|
Reasons for withdrawal
| Measure |
AZD0780 1 mg
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Screen Failure
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
2
|
1
|
0
|
2
|
0
|
Baseline Characteristics
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
Baseline characteristics by cohort
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
Total
n=426 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=202 Participants
|
10 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
12 Participants
n=122 Participants
|
8 Participants
n=79 Participants
|
41 Participants
n=806 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=202 Participants
|
75 Participants
n=283 Participants
|
78 Participants
n=120 Participants
|
73 Participants
n=122 Participants
|
78 Participants
n=79 Participants
|
385 Participants
n=806 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=202 Participants
|
59 Participants
n=283 Participants
|
39 Participants
n=120 Participants
|
50 Participants
n=122 Participants
|
47 Participants
n=79 Participants
|
242 Participants
n=806 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=202 Participants
|
26 Participants
n=283 Participants
|
45 Participants
n=120 Participants
|
35 Participants
n=122 Participants
|
39 Participants
n=79 Participants
|
184 Participants
n=806 Participants
|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 7.9 • n=202 Participants
|
60.9 Years
STANDARD_DEVIATION 7.2 • n=283 Participants
|
63.9 Years
STANDARD_DEVIATION 7.2 • n=120 Participants
|
62.3 Years
STANDARD_DEVIATION 7.9 • n=122 Participants
|
62.3 Years
STANDARD_DEVIATION 7.8 • n=79 Participants
|
62.4 Years
STANDARD_DEVIATION 7.6 • n=806 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=202 Participants
|
41 Participants
n=283 Participants
|
37 Participants
n=120 Participants
|
41 Participants
n=122 Participants
|
44 Participants
n=79 Participants
|
204 Participants
n=806 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=202 Participants
|
44 Participants
n=283 Participants
|
47 Participants
n=120 Participants
|
44 Participants
n=122 Participants
|
42 Participants
n=79 Participants
|
222 Participants
n=806 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
6 Participants
n=122 Participants
|
6 Participants
n=79 Participants
|
32 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
4 Participants
n=122 Participants
|
6 Participants
n=79 Participants
|
22 Participants
n=806 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=202 Participants
|
75 Participants
n=283 Participants
|
73 Participants
n=120 Participants
|
74 Participants
n=122 Participants
|
73 Participants
n=79 Participants
|
368 Participants
n=806 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
2 Participants
n=806 Participants
|
|
Low-Density Lipoprotein Cholesterol (LDL-C)
|
2.6822 mmol/L
STANDARD_DEVIATION 0.6918 • n=202 Participants
|
2.7258 mmol/L
STANDARD_DEVIATION 0.8960 • n=283 Participants
|
2.4784 mmol/L
STANDARD_DEVIATION 0.7122 • n=120 Participants
|
2.5500 mmol/L
STANDARD_DEVIATION 0.6939 • n=122 Participants
|
2.5769 mmol/L
STANDARD_DEVIATION 0.6620 • n=79 Participants
|
2.6031 mmol/L
STANDARD_DEVIATION 0.7378 • n=806 Participants
|
PRIMARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C \* 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12
|
-31.19 Percent Change (%)
Interval -37.06 to -25.32
|
-33.83 Percent Change (%)
Interval -39.78 to -27.88
|
-41.09 Percent Change (%)
Interval -46.92 to -35.25
|
-46.62 Percent Change (%)
Interval -52.48 to -40.76
|
4.08 Percent Change (%)
Interval -1.84 to 10.0
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C \* 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-30.47 Percent Change (%)
Interval -36.45 to -24.49
|
-33.35 Percent Change (%)
Interval -39.44 to -27.26
|
-40.47 Percent Change (%)
Interval -46.42 to -34.53
|
-46.41 Percent Change (%)
Interval -52.48 to -40.35
|
3.39 Percent Change (%)
Interval -2.63 to 9.4
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Total Cholesterol at Week 12
|
-18.93 Percent Change (%)
Interval -22.48 to -15.38
|
-20.09 Percent Change (%)
Interval -23.7 to -16.48
|
-24.84 Percent Change (%)
Interval -28.36 to -21.32
|
-27.06 Percent Change (%)
Interval -30.62 to -23.51
|
2.29 Percent Change (%)
Interval -1.29 to 5.88
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
|
0.12 Percent Change (%)
Interval -2.96 to 3.19
|
4.03 Percent Change (%)
Interval 0.93 to 7.12
|
1.97 Percent Change (%)
Interval -1.07 to 5.0
|
4.66 Percent Change (%)
Interval 1.6 to 7.72
|
3.65 Percent Change (%)
Interval 0.58 to 6.71
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Triglycerides at Week 12
|
3.06 Percent Change (%)
Interval -5.05 to 11.17
|
2.90 Percent Change (%)
Interval -5.29 to 11.08
|
1.93 Percent Change (%)
Interval -5.99 to 9.85
|
-0.44 Percent Change (%)
Interval -8.52 to 7.63
|
9.56 Percent Change (%)
Interval 1.47 to 17.65
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
|
-26.85 Percent Change (%)
Interval -32.65 to -21.04
|
-29.86 Percent Change (%)
Interval -35.75 to -23.97
|
-35.13 Percent Change (%)
Interval -40.92 to -29.35
|
-41.65 Percent Change (%)
Interval -47.45 to -35.85
|
3.53 Percent Change (%)
Interval -2.33 to 9.39
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12
|
1.13 Percent Change (%)
Interval -6.55 to 8.81
|
4.02 Percent Change (%)
Interval -3.69 to 11.73
|
2.21 Percent Change (%)
Interval -5.26 to 9.68
|
0.46 Percent Change (%)
Interval -7.15 to 8.07
|
7.19 Percent Change (%)
Interval -0.52 to 14.9
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Apolipoprotein A1 at Week 12
|
1.67 Percent Change (%)
Interval -1.0 to 4.34
|
3.25 Percent Change (%)
Interval 0.58 to 5.93
|
3.61 Percent Change (%)
Interval 1.02 to 6.21
|
5.72 Percent Change (%)
Interval 3.08 to 8.36
|
4.46 Percent Change (%)
Interval 1.8 to 7.12
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Apolipoprotein B at Week 12
|
-24.08 Percent Change (%)
Interval -28.37 to -19.8
|
-25.39 Percent Change (%)
Interval -29.71 to -21.07
|
-34.33 Percent Change (%)
Interval -38.53 to -30.12
|
-36.95 Percent Change (%)
Interval -41.2 to -32.71
|
2.92 Percent Change (%)
Interval -1.39 to 7.23
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Total Cholesterol at Week 12
|
-18.23 Percent Change (%)
Interval -21.88 to -14.58
|
-19.80 Percent Change (%)
Interval -23.54 to -16.07
|
-24.54 Percent Change (%)
Interval -28.14 to -20.94
|
-26.90 Percent Change (%)
Interval -30.6 to -23.2
|
1.73 Percent Change (%)
Interval -1.88 to 5.34
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
|
0.80 Percent Change (%)
Interval -2.29 to 3.89
|
3.66 Percent Change (%)
Interval 0.58 to 6.75
|
2.17 Percent Change (%)
Interval -0.85 to 5.19
|
4.65 Percent Change (%)
Interval 1.61 to 7.7
|
3.11 Percent Change (%)
Interval 0.11 to 6.12
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Triglycerides at Week 12
|
2.81 Percent Change (%)
Interval -5.25 to 10.86
|
2.17 Percent Change (%)
Interval -5.93 to 10.28
|
1.72 Percent Change (%)
Interval -6.09 to 9.54
|
-0.83 Percent Change (%)
Interval -8.87 to 7.22
|
9.04 Percent Change (%)
Interval 1.16 to 16.92
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
|
-26.13 Percent Change (%)
Interval -31.94 to -20.32
|
-29.42 Percent Change (%)
Interval -35.34 to -23.49
|
-34.77 Percent Change (%)
Interval -40.59 to -28.95
|
-41.35 Percent Change (%)
Interval -47.27 to -35.43
|
2.86 Percent Change (%)
Interval -2.91 to 8.62
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12
|
0.81 Percent Change (%)
Interval -6.81 to 8.43
|
2.67 Percent Change (%)
Interval -4.91 to 10.26
|
1.77 Percent Change (%)
Interval -5.59 to 9.13
|
0.42 Percent Change (%)
Interval -7.18 to 8.02
|
6.74 Percent Change (%)
Interval -0.68 to 14.15
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Apolipoprotein A1 at Week 12
|
2.52 Percent Change (%)
Interval -0.18 to 5.22
|
2.89 Percent Change (%)
Interval 0.14 to 5.64
|
3.79 Percent Change (%)
Interval 1.19 to 6.39
|
5.55 Percent Change (%)
Interval 2.88 to 8.22
|
3.82 Percent Change (%)
Interval 1.15 to 6.48
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained.
Outcome measures
| Measure |
AZD0780 1 mg
n=86 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Apolipoprotein B at Week 12
|
-23.35 Percent Change (%)
Interval -27.79 to -18.91
|
-24.53 Percent Change (%)
Interval -29.06 to -19.99
|
-33.85 Percent Change (%)
Interval -38.18 to -29.51
|
-36.86 Percent Change (%)
Interval -41.35 to -32.37
|
2.44 Percent Change (%)
Interval -2.0 to 6.89
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment. For this outcome, only participants with both baseline and week 12 values were included in the analysis.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.
Outcome measures
| Measure |
AZD0780 1 mg
n=75 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=75 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=81 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=76 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=78 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Lipoprotein-a at Week 12
|
-7.48 Percent Change (%)
Interval -64.6 to 319.6
|
-11.16 Percent Change (%)
Interval -56.7 to 2582.3
|
-19.57 Percent Change (%)
Interval -66.3 to 36.6
|
-19.43 Percent Change (%)
Interval -71.3 to 55.6
|
0.00 Percent Change (%)
Interval -46.3 to 98.9
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment. For this outcome, only participants with both baseline and week 12 values were included in the analysis.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.
Outcome measures
| Measure |
AZD0780 1 mg
n=75 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=75 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=79 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=77 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=80 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of Remnant Cholesterol at Week 12
|
-9.09 Percent Change (%)
Interval -77.8 to 160.0
|
-8.33 Percent Change (%)
Interval -169.7 to 671.4
|
-22.95 Percent Change (%)
Interval -1200.0 to 266.7
|
-18.31 Percent Change (%)
Interval -200.0 to 420.0
|
-5.00 Percent Change (%)
Interval -85.7 to 558.3
|
SECONDARY outcome
Timeframe: From first day of treatment up to week 12Population: Full Analysis Set: all randomized participants who received at least one dose of study treatment. For this outcome, only participants with both baseline and week 12 values were included in the analysis.
Percent change was calculated as (Week 12 value - Baseline value) / Baseline value \* 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only.
Outcome measures
| Measure |
AZD0780 1 mg
n=75 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=75 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=82 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=77 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=79 Participants
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Percent Change From Baseline of High Sensitivity C-reactive Protein (hsCRP) at Week 12
|
0.00 Percent Change (%)
Interval -96.8 to 2500.0
|
0.00 Percent Change (%)
Interval -79.8 to 716.7
|
0.00 Percent Change (%)
Interval -98.1 to 4950.0
|
-22.22 Percent Change (%)
Interval -93.3 to 2603.0
|
0.00 Percent Change (%)
Interval -75.7 to 1358.3
|
SECONDARY outcome
Timeframe: From week 1 up to week 12Population: PK Analysis Set: all participants who received at least one dose of study treatment and who had evaluable PK data.
Geometric mean plasma concentration; LLOQ = 0.01 umol/L; BLQ values are handled as Not Quantified (NQ)
Outcome measures
| Measure |
AZD0780 1 mg
n=85 Participants
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=83 Participants
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 Participants
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=84 Participants
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Week 1
|
0.0790 umol/L
Geometric Coefficient of Variation 76.7603
|
0.2523 umol/L
Geometric Coefficient of Variation 54.0463
|
0.8120 umol/L
Geometric Coefficient of Variation 72.6051
|
2.6420 umol/L
Geometric Coefficient of Variation 58.0213
|
—
|
|
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Week 2
|
0.0926 umol/L
Geometric Coefficient of Variation 71.7485
|
0.2639 umol/L
Geometric Coefficient of Variation 75.6804
|
0.8156 umol/L
Geometric Coefficient of Variation 95.1545
|
2.6676 umol/L
Geometric Coefficient of Variation 55.8538
|
—
|
|
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Week 4
|
0.0901 umol/L
Geometric Coefficient of Variation 81.2970
|
0.2380 umol/L
Geometric Coefficient of Variation 98.8448
|
0.8393 umol/L
Geometric Coefficient of Variation 74.6636
|
2.7059 umol/L
Geometric Coefficient of Variation 47.5671
|
—
|
|
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Week 8
|
0.0932 umol/L
Geometric Coefficient of Variation 68.6270
|
0.2359 umol/L
Geometric Coefficient of Variation 102.5351
|
0.8350 umol/L
Geometric Coefficient of Variation 92.9640
|
2.4911 umol/L
Geometric Coefficient of Variation 102.6420
|
—
|
|
AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
Week 12
|
0.0957 umol/L
Geometric Coefficient of Variation 61.8573
|
0.2317 umol/L
Geometric Coefficient of Variation 111.2636
|
0.7221 umol/L
Geometric Coefficient of Variation 119.9436
|
2.4373 umol/L
Geometric Coefficient of Variation 134.1014
|
—
|
Adverse Events
AZD0780 1 mg
AZD0780 3 mg
AZD0780 10 mg
AZD0780 30 mg
Placebo
Serious adverse events
| Measure |
AZD0780 1 mg
n=86 participants at risk
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 participants at risk
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 participants at risk
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 participants at risk
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 participants at risk
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Psychiatric disorders
Major Depression
|
1.2%
1/86 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/84 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/84 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
1.2%
1/84 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Nervous system disorders
Syncope
|
1.2%
1/86 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/84 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/84 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/86 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/84 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
1.2%
1/85 • Number of events 1 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/84 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/85 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
0.00%
0/86 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
Other adverse events
| Measure |
AZD0780 1 mg
n=86 participants at risk
Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 3 mg
n=85 participants at risk
Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 10 mg
n=84 participants at risk
Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks
|
AZD0780 30 mg
n=85 participants at risk
Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks
|
Placebo
n=86 participants at risk
Participants received placebo administered orally once daily for up to 12 weeks
|
|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
4.7%
4/86 • Number of events 4 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
2.4%
2/85 • Number of events 2 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
2.4%
2/84 • Number of events 2 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
3.5%
3/85 • Number of events 3 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
5.8%
5/86 • Number of events 5 • Adverse events were collected from start of study treatment, throughout the 12-week treatment period, and the 2-weeks follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca AB.
- Publication restrictions are in place
Restriction type: OTHER