Dyslipidemias, Hyperlipoproteinemia, Lipid Metabolism Disorders, Metabolic Diseases
Conditions
Keywords
Triglycerides, LDL Cholesterol, Mixed Dyslipidemia
Brief summary
This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.
Interventions
DRUGLY3561774
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening. * Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening. * Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at screening. * Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study. * Have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive
Exclusion criteria
* Have in the 6 months prior to screening, uncontrolled Type 1 or Type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin A1c (HbA1c) ≥8% at screening. * Have a history of nephrotic syndrome. * Have a history of acute or chronic pancreatitis. * Have had within the past 3 months prior to screening * Myocardial infarction * Unstable angina * Coronary artery bypass graft * Percutaneous coronary intervention - diagnostic angiograms are permitted * Peripheral artery disease * Transient ischemic attack, or * Cerebrovascular accident * Have New York Heart Association Class III or IV heart failure or last known left ventricular ejection fraction \<30%. * Have undergone LDL apheresis within 12 months prior to screening. * Have clinically relevant anemia, as defined by the investigator. * Have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity. * Have within 3 years prior to screening a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse. * Have uncontrolled hypertension. * Have used or are taking products for the purpose of lowering lipid levels (except for statins, PCSK9 inhibitors, bempedoic acid, and ezetimibe). This includes lipid-regulating medication, over-the-counter products, or herbal therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 | Baseline, Day 180 | Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180 | Baseline, Day 180 | Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180 | Baseline, Day 180 | Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180 | Baseline, Day 180 | Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for Triglycerides at Day 180 | Baseline, Day 180 | Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) | Baseline, Day 270 | Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180 | Baseline, Day 180 | Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) | Baseline, Day 270 | Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) | Baseline, Day 270 | Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Percent Change From Baseline for Apolipoprotein B (ApoB) | Baseline, Day 270 | Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline. |
| Percent Change From Baseline for Triglycerides | Baseline, Day 270 | Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
| Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774 | On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose | PK: Seady State AUC (0-∞) of LY3561774 |
| Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Baseline, Day 270 | Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment. |
Countries
Argentina, Canada, Japan, Mexico, Poland, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. | 58 |
| LY3561774 100 mg Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. | 30 |
| LY3561774 400 mg Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. | 58 |
| LY3561774 800 mg Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360. | 59 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Earthquake at the Turkey site prevented participation in the study | 0 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | LY3561774 100 mg | LY3561774 400 mg | Placebo | LY3561774 800 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.40 years STANDARD_DEVIATION 10.97 | 56.40 years STANDARD_DEVIATION 11.97 | 55.50 years STANDARD_DEVIATION 11.61 | 57.30 years STANDARD_DEVIATION 10.61 | 56.70 years STANDARD_DEVIATION 11.3 |
| Baseline Apolipoprotein B (ApoB) | 109.50 milligram per deciliter (mg/dL) | 112 milligram per deciliter (mg/dL) | 111 milligram per deciliter (mg/dL) | 114 milligram per deciliter (mg/dL) | 111 milligram per deciliter (mg/dL) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 39 Participants | 36 Participants | 44 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 19 Participants | 22 Participants | 15 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 14 Participants | 21 Participants | 22 Participants | 68 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 11 Participants | 9 Participants | 36 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 34 Participants | 25 Participants | 28 Participants | 100 Participants |
| Region of Enrollment Argentina | 8 Participants | 21 Participants | 15 Participants | 18 Participants | 62 Participants |
| Region of Enrollment Canada | 4 Participants | 7 Participants | 5 Participants | 2 Participants | 18 Participants |
| Region of Enrollment Japan | 4 Participants | 7 Participants | 7 Participants | 7 Participants | 25 Participants |
| Region of Enrollment Mexico | 12 Participants | 18 Participants | 21 Participants | 26 Participants | 77 Participants |
| Region of Enrollment Poland | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Region of Enrollment Turkey | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 11 Participants |
| Region of Enrollment United States | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Female | 18 Participants | 29 Participants | 35 Participants | 29 Participants | 111 Participants |
| Sex: Female, Male Male | 12 Participants | 29 Participants | 23 Participants | 30 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 30 | 0 / 58 | 0 / 59 |
| other Total, other adverse events | 16 / 57 | 14 / 30 | 14 / 58 | 9 / 59 |
| serious Total, serious adverse events | 5 / 57 | 1 / 30 | 3 / 58 | 2 / 59 |
Outcome results
Primary
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180
Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.
Time frame: Baseline, Day 180
Population: All randomized participants receiving at least 1 dose of study drug with evaluable apoB values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 | -11.6 Percent change | Standard Error 3.65 |
| LY3561774 100 mg | Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 | -14.1 Percent change | Standard Error 4.98 |
| LY3561774 400 mg | Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 | -24.3 Percent change | Standard Error 3.1 |
| LY3561774 800 mg | Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 | -19.0 Percent change | Standard Error 3.35 |
p-value: 0.69195% CI: [-15.5, 11.9]Mixed Models Analysis
p-value: 0.00895% CI: [-23.6, -3.9]Mixed Models Analysis
p-value: 0.1495% CI: [-18.3, 2.9]Mixed Models Analysis
Secondary
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)
Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Population: All randomized participants receiving at least 1 dose of study drug with evaluable ANGPTL3 values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) | -17.0 Percent change | Standard Error 6 |
| LY3561774 100 mg | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) | -49.0 Percent change | Standard Error 5.28 |
| LY3561774 400 mg | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) | -61.9 Percent change | Standard Error 2.75 |
| LY3561774 800 mg | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) | -69.8 Percent change | Standard Error 2.19 |
p-value: <0.00195% CI: [-52.2, -21.2]Mixed Models Analysis
p-value: <0.00195% CI: [-62.4, -43.8]Mixed Models Analysis
p-value: <0.00195% CI: [-70.3, 55.5]Mixed Models Analysis
Secondary
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180
Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Population: All randomized participants receiving at least 1 dose of study drug with evaluable ANGPTL3 values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180 | -3.2 Percent change | Standard Error 6.22 |
| LY3561774 100 mg | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180 | -55.7 Percent change | Standard Error 4.01 |
| LY3561774 400 mg | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180 | -70.8 Percent change | Standard Error 1.86 |
| LY3561774 800 mg | Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180 | -77.3 Percent change | Standard Error 1.46 |
p-value: <0.00195% CI: [-63.3, -43.1]Mixed Models Analysis
p-value: <0.00195% CI: [-74.8, -63.9]Mixed Models Analysis
p-value: <0.00195% CI: [-80.4, -72]Mixed Models Analysis
Secondary
Percent Change From Baseline for Apolipoprotein B (ApoB)
Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.
Time frame: Baseline, Day 270
Population: All randomized participants receiving at least 1 dose of study drug with evaluable apoB values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Apolipoprotein B (ApoB) | -9.5 Percent change | Standard Error 3.57 |
| LY3561774 100 mg | Percent Change From Baseline for Apolipoprotein B (ApoB) | -19.2 Percent change | Standard Error 4.61 |
| LY3561774 400 mg | Percent Change From Baseline for Apolipoprotein B (ApoB) | -19.7 Percent change | Standard Error 3.18 |
| LY3561774 800 mg | Percent Change From Baseline for Apolipoprotein B (ApoB) | -19.4 Percent change | Standard Error 3.2 |
p-value: 0.10195% CI: [-22.2, 2.3]Mixed Models Analysis
p-value: 0.03395% CI: [-20.6, -1]Mixed Models Analysis
p-value: 0.0495% CI: [-20.3, -0.6]Mixed Models Analysis
Secondary
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)
Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Population: All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) | 1.5 Percent change | Standard Error 2.48 |
| LY3561774 100 mg | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) | -1.9 Percent change | Standard Error 3.48 |
| LY3561774 400 mg | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) | -7.3 Percent change | Standard Error 2.24 |
| LY3561774 800 mg | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) | -10.9 Percent change | Standard Error 2.18 |
p-value: 0.42895% CI: [-11.2, 5.2]Mixed Models Analysis
p-value: 0.00995% CI: [-14.7, -2.3]Mixed Models Analysis
p-value: <0.00195% CI: [-18, -6]Mixed Models Analysis
Secondary
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180
Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Population: All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180 | 4.3 Percent change | Standard Error 2.59 |
| LY3561774 100 mg | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180 | -2.1 Percent change | Standard Error 3.43 |
| LY3561774 400 mg | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180 | -12.8 Percent change | Standard Error 2.15 |
| LY3561774 800 mg | Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180 | -19.4 Percent change | Standard Error 2 |
p-value: 0.14395% CI: [-13.8, 2.2]Mixed Models Analysis
p-value: <0.00195% CI: [-22, -10.5]Mixed Models Analysis
p-value: <0.00195% CI: [-27.9, -17.2]Mixed Models Analysis
Secondary
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)
Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Population: All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) | -12.7 Percent change | Standard Error 3.78 |
| LY3561774 100 mg | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) | -7.1 Percent change | Standard Error 5.81 |
| LY3561774 400 mg | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) | -21.0 Percent change | Standard Error 3.39 |
| LY3561774 800 mg | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) | -17.5 Percent change | Standard Error 3.57 |
p-value: 0.41295% CI: [-8.4, 23.7]Mixed Models Analysis
p-value: 0.10495% CI: [-19.7, 2.1]Mixed Models Analysis
p-value: 0.36395% CI: [-16.2, 6.7]Mixed Models Analysis
Secondary
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180
Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Population: All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C direct values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180 | -8.7 Percent change | Standard Error 3.87 |
| LY3561774 100 mg | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180 | -9.9 Percent change | Standard Error 5.39 |
| LY3561774 400 mg | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180 | -24.0 Percent change | Standard Error 3.21 |
| LY3561774 800 mg | Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180 | -19.7 Percent change | Standard Error 3.42 |
p-value: 0.85495% CI: [-14.6, 14]Mixed Models Analysis
p-value: 0.00295% CI: [-26, -6.4]Mixed Models Analysis
p-value: 0.03395% CI: [-21.9, -1.1]Mixed Models Analysis
Secondary
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Population: All randomized participants receiving at least 1 dose of study drug with evaluable non HDL-C values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | -9.8 Percent change | Standard Error 3.22 |
| LY3561774 100 mg | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | -13.5 Percent change | Standard Error 4.44 |
| LY3561774 400 mg | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | -27.6 Percent change | Standard Error 2.56 |
| LY3561774 800 mg | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | -27.3 Percent change | Standard Error 2.59 |
p-value: 0.50695% CI: [-15.2, 8.5]Mixed Models Analysis
p-value: <0.00195% CI: [-27.2, -11.3]Mixed Models Analysis
p-value: <0.00195% CI: [-27, -11]Mixed Models Analysis
Secondary
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180
Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Population: All randomized participants receiving at least 1 dose of study drug with evaluable Non HDL-C values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180 | -10.2 Percent change | Standard Error 3.24 |
| LY3561774 100 mg | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180 | -19.8 Percent change | Standard Error 4.06 |
| LY3561774 400 mg | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180 | -33.1 Percent change | Standard Error 2.41 |
| LY3561774 800 mg | Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180 | -31.5 Percent change | Standard Error 2.47 |
p-value: 0.06895% CI: [-21.1, 0.9]Mixed Models Analysis
p-value: <0.00195% CI: [-32.6, -17.6]Mixed Models Analysis
p-value: <0.00195% CI: [-31.1, -15.7]Mixed Models Analysis
Secondary
Percent Change From Baseline for Triglycerides
Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Population: All randomized participants receiving at least 1 dose of study drug with evaluable triglycerides values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Triglycerides | -13.9 Percent change | Standard Error 4.63 |
| LY3561774 100 mg | Percent Change From Baseline for Triglycerides | -38.3 Percent change | Standard Error 4.8 |
| LY3561774 400 mg | Percent Change From Baseline for Triglycerides | -50.5 Percent change | Standard Error 2.63 |
| LY3561774 800 mg | Percent Change From Baseline for Triglycerides | -52.5 Percent change | Standard Error 2.55 |
p-value: <0.00195% CI: [-40.5, -13.6]Mixed Models Analysis
p-value: <0.00195% CI: [-50.5, -33.2]Mixed Models Analysis
p-value: <0.00195% CI: [-52.5, -35.9]Mixed Models Analysis
Secondary
Percent Change From Baseline for Triglycerides at Day 180
Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Population: All randomized participants receiving at least 1 dose of study drug with evaluable triglycerides values at baseline, and at least 1 post-baseline measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline for Triglycerides at Day 180 | -15.1 Percent change | Standard Error 4.01 |
| LY3561774 100 mg | Percent Change From Baseline for Triglycerides at Day 180 | -45.9 Percent change | Standard Error 3.61 |
| LY3561774 400 mg | Percent Change From Baseline for Triglycerides at Day 180 | -57.8 Percent change | Standard Error 1.98 |
| LY3561774 800 mg | Percent Change From Baseline for Triglycerides at Day 180 | -59.7 Percent change | Standard Error 1.9 |
p-value: <0.00195% CI: [-45.8, -25.1]Mixed Models Analysis
p-value: <0.00195% CI: [-56.4, -43.3]Mixed Models Analysis
p-value: <0.00195% CI: [-58.4, -45.9]Mixed Models Analysis
Secondary
Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774
PK: Seady State AUC (0-∞) of LY3561774
Time frame: On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774 | 6979 nanogram.hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 35 |
| LY3561774 100 mg | Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774 | 25045 nanogram.hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 24 |
| LY3561774 400 mg | Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774 | 61306 nanogram.hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 43 |