Trial Outcomes & Findings for A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels (NCT NCT01388816)

Results Overview

Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

176 participants

Primary outcome timeframe

28 days

Results posted on

2014-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Once daily after breakfast	DRL-17822 50 mg Once daily after breakfast	DRL-17822 150 mg Once daily after breakfast	DRL-17822 300 mg Once daily after breakfast
Overall Study STARTED	45	43	44	44
Overall Study COMPLETED	43	39	41	44
Overall Study NOT COMPLETED	2	4	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Once daily after breakfast	DRL-17822 50 mg Once daily after breakfast	DRL-17822 150 mg Once daily after breakfast
Overall Study Adverse Event	0	2	0
Overall Study Lost to Follow-up	0	1	0
Overall Study Withdrawal by Subject	2	1	1
Overall Study Protocol Violation	0	0	2

Baseline Characteristics

A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Capsule n=45 Participants Once daily after breakfast	DRL-17822 50 mg n=43 Participants Once daily after breakfast	DRL-17822 150 mg n=44 Participants Once daily after breakfast	DRL-17822 300 mg n=44 Participants Once daily after breakfast	Total n=176 Participants Total of all reporting groups
Age, Continuous	57.0 Years STANDARD_DEVIATION 8.49 • n=5 Participants	55.8 Years STANDARD_DEVIATION 9.93 • n=7 Participants	54.2 Years STANDARD_DEVIATION 10.48 • n=5 Participants	56.2 Years STANDARD_DEVIATION 10.74 • n=4 Participants	55.8 Years STANDARD_DEVIATION 9.91 • n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	26 Participants n=7 Participants	19 Participants n=5 Participants	26 Participants n=4 Participants	99 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	25 Participants n=5 Participants	18 Participants n=4 Participants	77 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	43 Participants n=7 Participants	43 Participants n=5 Participants	44 Participants n=4 Participants	175 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Intention to treat (ITT) analysis with last observation carried forward (LOCF) for missing data.

Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia

Outcome measures

Outcome measures
Measure	Placebo Capsule n=44 Participants Once daily after breakfast	DRL-17822 50 mg n=42 Participants Once daily after breakfast	DRL-17822 150 mg n=43 Participants Once daily after breakfast	DRL-17822 300 mg n=44 Participants Once daily after breakfast
Percent Change in HDL-C From Baseline	3.2 percent change from baseline 95% Confidence Interval 16.723 • Interval -10.8 to 17.3	84.2 percent change from baseline 95% Confidence Interval 42.000 • Interval 69.8 to 98.6	122.1 percent change from baseline 95% Confidence Interval 60.035 • Interval 107.8 to 136.3	160.6 percent change from baseline 95% Confidence Interval 57.325 • Interval 146.5 to 174.6

SECONDARY outcome

Timeframe: 28 days

Population: Safety/ITT Population

Incidence of treatment-related adverse events

Outcome measures

Outcome measures
Measure	Placebo Capsule n=45 Participants Once daily after breakfast	DRL-17822 50 mg n=43 Participants Once daily after breakfast	DRL-17822 150 mg n=43 Participants Once daily after breakfast	DRL-17822 300 mg n=44 Participants Once daily after breakfast
Safety and Tolerability of DRL-17822 Treatment-related AEs	4 participants	3 participants	3 participants	4 participants
Safety and Tolerability of DRL-17822 Severe AEs	1 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 28 days

Population: ITT/Safety Population

Vital sign abnormalities reported as treatment-emergent AEs

Outcome measures

Outcome measures
Measure	Placebo Capsule n=45 Participants Once daily after breakfast	DRL-17822 50 mg n=43 Participants Once daily after breakfast	DRL-17822 150 mg n=43 Participants Once daily after breakfast	DRL-17822 300 mg n=44 Participants Once daily after breakfast
Changes in Vital Signs Including Blood Pressure	2 participants	1 participants	1 participants	2 participants

SECONDARY outcome

Timeframe: 28 days

Trough levels of DRL-17822 in plasma after 28 days of treatment

Outcome measures

Outcome measures
Measure	Placebo Capsule n=40 Participants Once daily after breakfast	DRL-17822 50 mg n=41 Participants Once daily after breakfast	DRL-17822 150 mg n=44 Participants Once daily after breakfast	DRL-17822 300 mg Once daily after breakfast
To Evaluate Trough Levels of DRL-17822 in Plasma	315.6 ng/mL Standard Deviation 227.2	826.2 ng/mL Standard Deviation 1124.6	1341.3 ng/mL Standard Deviation 1121.5	—

SECONDARY outcome

Timeframe: 28 days

Population: ITT with LOCF

Percent change from baseline in CETP Inhibition

Outcome measures

Outcome measures
Measure	Placebo Capsule n=44 Participants Once daily after breakfast	DRL-17822 50 mg n=42 Participants Once daily after breakfast	DRL-17822 150 mg n=43 Participants Once daily after breakfast	DRL-17822 300 mg n=44 Participants Once daily after breakfast
Changes in CETP Inhibition in Plasma	7.2 percentage from baseline Interval 0.3 to 14.1	60.5 percentage from baseline Interval 53.4 to 67.6	79.7 percentage from baseline Interval 72.6 to 86.8	82.0 percentage from baseline Interval 75.2 to 88.9

SECONDARY outcome

Timeframe: 28 days

Population: ITT with LOCF

Change from baseline (LOCF, ITT population)

Outcome measures

Outcome measures
Measure	Placebo Capsule n=44 Participants Once daily after breakfast	DRL-17822 50 mg n=42 Participants Once daily after breakfast	DRL-17822 150 mg n=43 Participants Once daily after breakfast	DRL-17822 300 mg n=44 Participants Once daily after breakfast
Changes in Other Lipids and Apolipoproteins LDL-C	4.9 percentage change from baseline Interval -5.8 to 15.5	-15.4 percentage change from baseline Interval -26.3 to -4.5	-18.7 percentage change from baseline Interval -29.5 to -7.9	-39.4 percentage change from baseline Interval -50.1 to -28.8
Changes in Other Lipids and Apolipoproteins HDL-C/LDL-C Ratio	0.6 percentage change from baseline Interval -41.2 to 42.3	140.6 percentage change from baseline Interval 97.9 to 183.3	240.0 percentage change from baseline Interval 197.8 to 282.2	385.2 percentage change from baseline Interval 343.5 to 427.0
Changes in Other Lipids and Apolipoproteins Total Cholesterol	1.5 percentage change from baseline Interval -2.9 to 5.8	-0.9 percentage change from baseline Interval -5.3 to 3.5	-0.8 percentage change from baseline Interval -5.2 to 3.5	-0.8 percentage change from baseline Interval -5.1 to 3.5
Changes in Other Lipids and Apolipoproteins Triglycerides	4.5 percentage change from baseline Interval -7.7 to 16.7	-14.2 percentage change from baseline Interval -26.7 to -1.7	0.9 percentage change from baseline Interval -11.5 to 13.2	-11.3 percentage change from baseline Interval -23.5 to 1.0
Changes in Other Lipids and Apolipoproteins Apo A1	1.8 percentage change from baseline Interval -4.1 to 7.7	35.0 percentage change from baseline Interval 29.0 to 41.1	44.8 percentage change from baseline Interval 38.8 to 50.8	59.1 percentage change from baseline Interval 53.2 to 65.1
Changes in Other Lipids and Apolipoproteins Apo B	2.9 percentage change from baseline Interval -2.4 to 8.2	-15.1 percentage change from baseline Interval -20.5 to -9.7	-22.2 percentage change from baseline Interval -27.6 to -16.9	-28.9 percentage change from baseline Interval -34.2 to -23.6
Changes in Other Lipids and Apolipoproteins Apo E	3.9 percentage change from baseline Interval -13.7 to 21.4	2.6 percentage change from baseline Interval -15.3 to 20.6	10.9 percentage change from baseline Interval -6.9 to 28.6	32.5 percentage change from baseline Interval 15.0 to 50.1
Changes in Other Lipids and Apolipoproteins Apo Lp(a)	2.8 percentage change from baseline Interval -34.4 to 40.0	-26.2 percentage change from baseline Interval -63.9 to 11.4	10.0 percentage change from baseline Interval -26.2 to 46.2	-37.7 percentage change from baseline Interval -75.4 to -0.1

Adverse Events

Placebo Capsule

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

DRL-17822 50 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

DRL-17822 150 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

DRL-17822 300 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Capsule n=45 participants at risk Once daily after breakfast	DRL-17822 50 mg n=43 participants at risk Once daily after breakfast	DRL-17822 150 mg n=43 participants at risk Once daily after breakfast	DRL-17822 300 mg n=44 participants at risk Once daily after breakfast
Infections and infestations Abscess	2.2% 1/45 • Number of events 1 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/45 • From randomization to 28 days of treatment	2.3% 1/43 • Number of events 1 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment

Other adverse events

Other adverse events
Measure	Placebo Capsule n=45 participants at risk Once daily after breakfast	DRL-17822 50 mg n=43 participants at risk Once daily after breakfast	DRL-17822 150 mg n=43 participants at risk Once daily after breakfast	DRL-17822 300 mg n=44 participants at risk Once daily after breakfast
Gastrointestinal disorders Nausea	2.2% 1/45 • From randomization to 28 days of treatment	2.3% 1/43 • From randomization to 28 days of treatment	4.7% 2/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment
Nervous system disorders Headache	0.00% 0/45 • From randomization to 28 days of treatment	2.3% 1/43 • From randomization to 28 days of treatment	2.3% 1/43 • From randomization to 28 days of treatment	4.5% 2/44 • From randomization to 28 days of treatment
Investigations Pyrexia	2.2% 1/45 • From randomization to 28 days of treatment	4.7% 2/43 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment
Infections and infestations Nasopharyngitis	0.00% 0/45 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	7.0% 3/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment
Gastrointestinal disorders Abdominal Pain	4.4% 2/45 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment
Infections and infestations Respiratory Tract Infection	4.4% 2/45 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment
Renal and urinary disorders Pollakiuria	4.4% 2/45 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/43 • From randomization to 28 days of treatment	0.00% 0/44 • From randomization to 28 days of treatment

Additional Information

Kent Allenby, MD

Proprietary Products, Dr. Reddy's Laboratories, Inc.

Phone: 609-375-9855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60