GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol

A Multi-center, Three-staged With Interim Analyses, Parallel, Randomized, Double-blind, fenofibrate-and Placebo-controlled Proof of Concept and Dose-response Evaluation of the Safety, Tolerability, and Effects on Plasma High-density Lipoprotein Cholesterol (HDLc) and Triglycerides of Eight Weeks Treatment With GW501516 in Otherwise Healthy Patients With Low HDLc, Mildly to Moderately Elevated Triglycerides, and Normal Low-density Lipoprotein Cholesterol (LDLc)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158899

Enrollment

424

Registered

2005-09-12

Start date

2004-08-31

Completion date

2006-06-30

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia, Dyslipidaemias

Keywords

HDLc, high-density lipoprotein, Dyslipidemia

Brief summary

The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving (raising) low levels of good cholesterol, high-density lipoprotein cholesterol (HDLc), as compared to placebo.

Detailed description

A multicentre, two-staged with interim analysis, parallel, randomised, double blind, placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg daily doses of GW501516 in subjects with low HDLc

Interventions

DRUGGW501516 oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Have a fasting plasma HDLc concentration \<=45mg/dL (\<=1.16mmol/L), plasma LDLc levels that do not require treatment according to the National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPÂ III) guidelines. * Have a fasting plasma TG concentration =500mg/dL (=5.65mmol/L).

Exclusion criteria

* Coronary heart disease. * Diabetes mellitus. * Atherosclerotic disease.

Design outcomes

Primary

Measure	Time frame
The change from baseline in fasting plasma HDLc concentration at the end of 12 weeks of double-blind treatment.	12 Weeks

Secondary

Measure	Time frame
Changes from baseline at the end of 12 weeks of double-blind treatment of total cholesterol and other lipid parameters. Population pharmacokinetic parameters including oral clearance and apparent volume of distribution of GW501516.	12 Weeks

Countries

Belgium, Denmark, Estonia, Finland, France, Germany, Lithuania, Netherlands, Norway, Portugal, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026