Trial Outcomes & Findings for A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia (NCT NCT02260635)

Last Updated: 2018-10-09

Results Overview

Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

54 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2018-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Evacetrapib 130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.	Placebo Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
Double-Blind Treatment Period STARTED	27	27
Double-Blind Treatment Period Received at Least One Dose of Study Drug	27	26
Double-Blind Treatment Period COMPLETED	26	25
Double-Blind Treatment Period NOT COMPLETED	1	2
Open-Label Extension STARTED	26	25
Open-Label Extension Received at Least One Dose of Study Drug	26	25
Open-Label Extension COMPLETED	0	0
Open-Label Extension NOT COMPLETED	26	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Evacetrapib 130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.	Placebo Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.
Double-Blind Treatment Period Failure to Meet Randomization Criteria	1	2
Open-Label Extension Study Termination	25	25
Open-Label Extension Withdrawal by Subject	1	0

Baseline Characteristics

A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evacetrapib n=27 Participants 130 milligrams (mg) evacetrapib given orally once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.	Placebo n=27 Participants Placebo given orally once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.	Total n=54 Participants Total of all reporting groups
Age, Continuous	52.2 years STANDARD_DEVIATION 10.19 • n=5 Participants	53.3 years STANDARD_DEVIATION 10.13 • n=7 Participants	52.8 years STANDARD_DEVIATION 10.08 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values measured by beta quantification at baseline, and at least 1 post-baseline measurement.

Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Outcome measures

Outcome measures
Measure	Evacetrapib n=26 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=25 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification	-34.27 percent change in LDL-C Standard Error 3.908	0.00 percent change in LDL-C Standard Error 3.984

SECONDARY outcome

Timeframe: Baseline, Week 12

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.

LS mean using MMRM adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Outcome measures

Outcome measures
Measure	Evacetrapib n=26 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=25 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	123.57 percent change of HDL-C Standard Error 6.697	-0.45 percent change of HDL-C Standard Error 6.805

SECONDARY outcome

Timeframe: Baseline, Week 12

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.

LS mean using MMRM adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Outcome measures

Outcome measures
Measure	Evacetrapib n=26 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=25 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline in LDL-C (Direct)	-33.86 percent change of LDL-C direct Standard Error 3.163	0.22 percent change of LDL-C direct Standard Error 3.226

SECONDARY outcome

Timeframe: Baseline, Week 12

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.

LS mean using MMRM adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Outcome measures

Outcome measures
Measure	Evacetrapib n=26 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=25 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline in Non HDL-C	-26.48 percent change in non HDL-C Standard Error 3.171	-0.03 percent change in non HDL-C Standard Error 3.237

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 52

Population: All randomized participants receiving at least 1 dose of study drug with evaluable Lipoprotein-a values at baseline, and at least 1 post-baseline measurement.

LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.

Outcome measures

Outcome measures
Measure	Evacetrapib n=17 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=24 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline in Lipoprotein-a Week 12	-35.71 percent change in Lipoprotein-a Standard Error 6.574	3.54 percent change in Lipoprotein-a Standard Error 5.532
Percent Change From Baseline in Lipoprotein-a Week 52	NA percent change in Lipoprotein-a Standard Error NA Week 52 data not available due to early termination of this study.	NA percent change in Lipoprotein-a Standard Error NA Week 52 data not available due to early termination of this study.

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 52

Population: All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein A-I values at baseline, and at least 1 post-baseline measurement.

LS Mean from ANCOVA model adjusted for baseline and treatment.

Outcome measures

Outcome measures
Measure	Evacetrapib n=27 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=26 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline in Apolipoprotein A-I Week 12	49.1 percent change in Apolipoprotein A-I Standard Error 3.44	-2.5 percent change in Apolipoprotein A-I Standard Error 3.51
Percent Change From Baseline in Apolipoprotein A-I Week 52	NA percent change in Apolipoprotein A-I Standard Error NA Week 52 data not available due to early termination of this study.	NA percent change in Apolipoprotein A-I Standard Error NA Week 52 data not available due to early termination of this study.

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 52

Population: All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein B values at baseline, and at least 1 post-baseline measurement.

LS Mean from ANCOVA model adjusted for baseline and treatment.

Outcome measures

Outcome measures
Measure	Evacetrapib n=27 Participants 130 milligrams (mg) evacetrapib given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo n=26 Participants Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Percent Change From Baseline in Apolipoprotein B Week 12	-29.0 percent change in Apolipoprotein B Standard Error 2.65	-1.3 percent change in Apolipoprotein B Standard Error 2.70
Percent Change From Baseline in Apolipoprotein B Week 52	NA percent change in Apolipoprotein B Standard Error NA Week 52 data not available due to early termination of this study.	NA percent change in Apolipoprotein B Standard Error NA Week 52 data not available due to early termination of this study.

Adverse Events

Evacetrapib Double Blind Treatment Period

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Double Blind Treatment Period

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Evacetrapib Open Label Extension

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo/Evacetrapib Open Label Extension

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Evacetrapib Double Blind Treatment Period n=27 participants at risk 130mg evacetrapib given PO once a day for 12 weeks.	Placebo Double Blind Treatment Period n=26 participants at risk Placebo given PO once a day for 12 weeks	Evacetrapib Open Label Extension n=26 participants at risk Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.	Placebo/Evacetrapib Open Label Extension n=25 participants at risk Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.
Infections and infestations Pharyngitis	3.7% 1/27 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Tonsillitis	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	3.7% 1/27 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Investigations Blood pressure increased	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Investigations Influenza b virus test positive	3.7% 1/27 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	4.0% 1/25 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	4.0% 1/25 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Occipital neuralgia	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Surgical and medical procedures Wisdom teeth removal	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	4.0% 1/25 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Eye disorders Conjunctivitis allergic	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	4.0% 1/25 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	3.7% 1/27 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	4.0% 1/25 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Acute sinusitis	0.00% 0/27 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Influenza	3.7% 1/27 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/26 All randomized participants who received at least 1 dose of study drug.	0.00% 0/25 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	7.4% 2/27 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	11.5% 3/26 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	11.5% 3/26 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	4.0% 1/25 • Number of events 1 All randomized participants who received at least 1 dose of study drug.