Study In Patients With Dyslipidaemia

A Randomised,Double-blind, Parallel Group, Placebo-controlled, Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of Oral GW677954 Capsules 2.5mg, 5mg, 10mg and 20mg a Day for 24 Weeks in Overweight Dyslipidaemic Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264667

Enrollment

290

Registered

2005-12-13

Start date

2005-12-31

Completion date

2007-06-30

Last updated

2016-10-28

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

Conditions

Metabolic Syndrome X

Keywords

Dyslipidaemia

Brief summary

Study in patients with dyslipidaemia.

Interventions

DRUGGW677954

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Waist circumference =102cm (men) or =88cm (women) at visit 1. * Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1. * Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1. * Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1.

Exclusion criteria

* History of diabetes * History of cardiovascular disease * Diagnosis of genetic lipid disorders * History of muscle pain * History of cancer

Design outcomes

Primary

Measure	Time frame
Percentage change from baseline in non-HDL-C based on log-transformed data at week 24.	—

Secondary

Measure	Time frame
Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference.	—

Countries

Argentina, Australia, Chile, Costa Rica, India, Latvia, Mexico, New Zealand, Pakistan, Romania, Russia, Slovakia, Spain

Outcome results

None listed

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