Hypertriglyceridemia
Conditions
Brief summary
This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia .
Interventions
DRUGAZD0585
1g soft capsule
DRUGAZD0585 placebo
1g soft capsule
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Japanese men or women, ≥20 years of age. * Subjects must meet all of the following criteria; 1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL 2. %TG change between Visit 2 and Visit 3 must be within 30% 3. %LDL-C change between Visit 2 and Visit 3 must be within 25% Key
Exclusion criteria
* Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters. * Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency or familial dysbetalipoproteinemia. * Current or history of pancreatitis. * Type I diabetes mellitus, use of insulin, or haemoglobin A1c \>10% at Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides | From baseline to Week12 | To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia. |
| Safety of AZD0585 by Assessment of Adverse Events in Patients | From baseline to Week52 | To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | From baseline to Week12 | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E. |
| Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | From baseline to Week12 | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol. |
| Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | From baseline to Week12 | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). |
| Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | From baseline to Week12 | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). |
| Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | From baseline to Week12 | To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate. |
Countries
Japan
Participant flow
Recruitment details
This study was conducted in 26 sites in Japan between 10 June 2015 and 08 March 2017.
Pre-assignment details
The study duration was up to 60 weeks, consisting of an initial screening period of 8 weeks and a 52-week treatment period.
Participants by arm
| Arm | Count |
|---|---|
| AZD0585 2g Group AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily | 152 |
| AZD0585 4g Group AZD0585 1g × 4 capsules once daily | 154 |
| Placebo Control Group AZD0585 placebo 1g × 4 capsules once daily | 76 |
| Total | 382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 5 | 1 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Eligibility criteria not fulfilled | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 2 | 0 |
| Overall Study | Reason not specified | 7 | 9 | 4 |
Baseline characteristics
| Characteristic | AZD0585 2g Group | AZD0585 4g Group | Placebo Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 56.9 Years STANDARD_DEVIATION 10.1 | 56.5 Years STANDARD_DEVIATION 11.2 | 57.4 Years STANDARD_DEVIATION 10.9 | 56.9 Years STANDARD_DEVIATION 10.7 |
| Baseline HDL-C < 40 mg/dL | 43 Participants | 52 Participants | 22 Participants | 117 Participants |
| Baseline HDL-C >= 40 mg/dL | 109 Participants | 102 Participants | 54 Participants | 265 Participants |
| Baseline LDL-C < 140 mg/dL | 134 Participants | 141 Participants | 66 Participants | 341 Participants |
| Baseline LDL-C >= 140 mg/dL | 18 Participants | 13 Participants | 10 Participants | 41 Participants |
| Baseline triglyceride < 300 mg/dL | 132 Participants | 127 Participants | 64 Participants | 323 Participants |
| Baseline triglyceride >= 300 mg/dL | 20 Participants | 27 Participants | 12 Participants | 59 Participants |
| BMI | 26.9 kg/m2 STANDARD_DEVIATION 4 | 26.9 kg/m2 STANDARD_DEVIATION 4 | 26.8 kg/m2 STANDARD_DEVIATION 3.9 | 26.9 kg/m2 STANDARD_DEVIATION 4 |
| Concurrent use of statin No | 73 Participants | 76 Participants | 38 Participants | 187 Participants |
| Concurrent use of statin Yes | 79 Participants | 78 Participants | 38 Participants | 195 Participants |
| Diabetes No | 92 Participants | 86 Participants | 47 Participants | 225 Participants |
| Diabetes Yes | 60 Participants | 68 Participants | 29 Participants | 157 Participants |
| established CVD No | 130 Participants | 141 Participants | 67 Participants | 338 Participants |
| established CVD Yes | 22 Participants | 13 Participants | 9 Participants | 44 Participants |
| Height | 166.1 cm STANDARD_DEVIATION 7.8 | 167.6 cm STANDARD_DEVIATION 7.7 | 166.4 cm STANDARD_DEVIATION 9 | 166.8 cm STANDARD_DEVIATION 8 |
| Hypertension No | 55 Participants | 51 Participants | 32 Participants | 138 Participants |
| Hypertension Yes | 97 Participants | 103 Participants | 44 Participants | 244 Participants |
| Race/Ethnicity, Customized Asian | 152 Participants | 154 Participants | 76 Participants | 382 Participants |
| Sex: Female, Male Female | 41 Participants | 29 Participants | 13 Participants | 83 Participants |
| Sex: Female, Male Male | 111 Participants | 125 Participants | 63 Participants | 299 Participants |
| Weight | 74.5 kg STANDARD_DEVIATION 12.8 | 75.8 kg STANDARD_DEVIATION 14.1 | 74.4 kg STANDARD_DEVIATION 13.2 | 75.0 kg STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 152 | 0 / 154 | 0 / 77 |
| other Total, other adverse events | 127 / 152 | 135 / 154 | 55 / 77 |
| serious Total, serious adverse events | 6 / 152 | 6 / 154 | 4 / 77 |
Outcome results
Primary
Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
Time frame: From baseline to Week12
Population: The Full Analysis Set included all randomized patients who had both any baseline and any post-baseline efficacy measurements.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides | -15.57 % (percent change from baseline) | Standard Error 1.7 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides | -21.78 % (percent change from baseline) | Standard Error 1.95 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides | 11.15 % (percent change from baseline) | Standard Error 4.65 |
p-value: <0.000195% CI: [-36.55, -16.88]ANCOVA
p-value: <0.000195% CI: [-42.93, -22.92]ANCOVA
Primary
Safety of AZD0585 by Assessment of Adverse Events in Patients
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
Time frame: From baseline to Week52
Population: The Safety Analysis Set included all patients who took at least 1 dose of double-blind investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AZD0585 2g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE | 127 Participants |
| AZD0585 2g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE with outcome = death | 1 Participants |
| AZD0585 2g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any serious AE | 6 Participants |
| AZD0585 2g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE leading to discontinuation of IP | 6 Participants |
| AZD0585 2g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any causally related AE | 16 Participants |
| AZD0585 2g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any severe AE | 4 Participants |
| AZD0585 4g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any severe AE | 1 Participants |
| AZD0585 4g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE | 135 Participants |
| AZD0585 4g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE leading to discontinuation of IP | 5 Participants |
| AZD0585 4g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any causally related AE | 36 Participants |
| AZD0585 4g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE with outcome = death | 0 Participants |
| AZD0585 4g Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any serious AE | 6 Participants |
| Placebo Control Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE with outcome = death | 0 Participants |
| Placebo Control Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any serious AE | 4 Participants |
| Placebo Control Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any severe AE | 0 Participants |
| Placebo Control Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE leading to discontinuation of IP | 1 Participants |
| Placebo Control Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any AE | 55 Participants |
| Placebo Control Group | Safety of AZD0585 by Assessment of Adverse Events in Patients | Any causally related AE | 8 Participants |
Secondary
Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol.
Time frame: From baseline to Week12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Non-high-density lipoprotein cholesterol | -1.33 % (percent change from baseline) | Standard Error 1.05 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | High-density lipoprotein cholesterol | 2.64 % (percent change from baseline) | Standard Error 0.83 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Total cholesterol | -0.34 % (percent change from baseline) | Standard Error 0.78 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Low-density lipoprotein cholesterol | 1.45 % (percent change from baseline) | Standard Error 1.18 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Very low-density lipoprotein cholesterol | -10.18 % (percent change from baseline) | Standard Error 2.62 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | High-density lipoprotein cholesterol | 1.54 % (percent change from baseline) | Standard Error 0.86 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Total cholesterol | -1.95 % (percent change from baseline) | Standard Error 1.29 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Low-density lipoprotein cholesterol | -2.17 % (percent change from baseline) | Standard Error 1.91 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Non-high-density lipoprotein cholesterol | -3.11 % (percent change from baseline) | Standard Error 1.74 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Very low-density lipoprotein cholesterol | -18.35 % (percent change from baseline) | Standard Error 2.73 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Very low-density lipoprotein cholesterol | 7.06 % (percent change from baseline) | Standard Error 3.84 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Non-high-density lipoprotein cholesterol | 3.05 % (percent change from baseline) | Standard Error 1.83 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Total cholesterol | 2.31 % (percent change from baseline) | Standard Error 1.31 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | High-density lipoprotein cholesterol | 1.33 % (percent change from baseline) | Standard Error 1.22 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile | Low-density lipoprotein cholesterol | 2.90 % (percent change from baseline) | Standard Error 2.1 |
Secondary
Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E.
Time frame: From baseline to Week12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo C-III | -2.50 % (percent change from baseline) | Standard Error 2.03 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo B | 1.73 % (percent change from baseline) | Standard Error 1.05 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo A-I | 0.39 % (percent change from baseline) | Standard Error 0.84 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo E | 5.25 % (percent change from baseline) | Standard Error 2.08 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo C-II | -2.98 % (percent change from baseline) | Standard Error 1.82 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo B48 | -2.87 % (percent change from baseline) | Standard Error 4.86 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo A-II | -3.20 % (percent change from baseline) | Standard Error 0.85 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo B | -0.30 % (percent change from baseline) | Standard Error 1.07 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo B48 | 0.94 % (percent change from baseline) | Standard Error 5.26 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo C-II | -6.20 % (percent change from baseline) | Standard Error 2.26 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo C-III | -5.47 % (percent change from baseline) | Standard Error 2.2 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo E | 6.27 % (percent change from baseline) | Standard Error 2.06 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo A-I | -0.42 % (percent change from baseline) | Standard Error 0.83 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo A-II | -5.01 % (percent change from baseline) | Standard Error 0.8 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo B48 | 41.58 % (percent change from baseline) | Standard Error 17.49 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo A-I | 0.55 % (percent change from baseline) | Standard Error 1.1 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo C-II | 5.49 % (percent change from baseline) | Standard Error 2.45 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo B | 2.60 % (percent change from baseline) | Standard Error 1.79 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo A-II | 0.31 % (percent change from baseline) | Standard Error 1.01 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo E | 9.67 % (percent change from baseline) | Standard Error 3.08 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile | Apo C-III | 5.56 % (percent change from baseline) | Standard Error 2.91 |
Secondary
Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Time frame: From baseline to Week12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | hs-CRP | 119.94 % (percent change from baseline) | Standard Error 59.65 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | Lp(a) | 14.84 % (percent change from baseline) | Standard Error 4.31 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | RLP-C | 5.85 % (percent change from baseline) | Standard Error 6.84 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | PCSK9 | 3.20 % (percent change from baseline) | Standard Error 2.79 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | Lp(a) | 22.69 % (percent change from baseline) | Standard Error 3.97 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | hs-CRP | 15.24 % (percent change from baseline) | Standard Error 19.29 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | PCSK9 | 0.51 % (percent change from baseline) | Standard Error 3.1 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | RLP-C | 54.86 % (percent change from baseline) | Standard Error 55.3 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | RLP-C | 53.80 % (percent change from baseline) | Standard Error 16.67 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | hs-CRP | 69.61 % (percent change from baseline) | Standard Error 42.95 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | Lp(a) | 3.18 % (percent change from baseline) | Standard Error 5.04 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP | PCSK9 | 13.53 % (percent change from baseline) | Standard Error 4.57 |
Secondary
Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate.
Time frame: From baseline to Week12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | EPA | 153.06 % (percent change from baseline) | Standard Error 10.4 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | DHA | 14.21 % (percent change from baseline) | Standard Error 2.5 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | AA | -7.26 % (percent change from baseline) | Standard Error 1.33 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | EPA/AA ratio | 169.64 % (percent change from baseline) | Standard Error 11.12 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | EPA/AA ratio | 319.90 % (percent change from baseline) | Standard Error 20.02 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | EPA | 265.34 % (percent change from baseline) | Standard Error 15.86 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | AA | -10.00 % (percent change from baseline) | Standard Error 1.39 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | DHA | 20.10 % (percent change from baseline) | Standard Error 2.45 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | EPA/AA ratio | -2.19 % (percent change from baseline) | Standard Error 9.23 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | DHA | 0.13 % (percent change from baseline) | Standard Error 4.13 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | AA | 0.86 % (percent change from baseline) | Standard Error 1.82 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile. | EPA | 3.60 % (percent change from baseline) | Standard Error 10.25 |
Secondary
Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Time frame: From baseline to Week12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | Small dense LDL | -0.49 % (percent change from baseline) | Standard Error 2.08 |
| AZD0585 2g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | LDL-C/Apo B ratio | 0.58 % (percent change from baseline) | Standard Error 0.99 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | Small dense LDL | -1.72 % (percent change from baseline) | Standard Error 2.05 |
| AZD0585 4g Group | Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | LDL-C/Apo B ratio | -1.77 % (percent change from baseline) | Standard Error 1.63 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | Small dense LDL | 5.19 % (percent change from baseline) | Standard Error 2.91 |
| Placebo Control Group | Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio | LDL-C/Apo B ratio | 0.66 % (percent change from baseline) | Standard Error 1.41 |