Phase 2 Completed N=564 Randomized Double-blind Treatment

The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Metabolism and Nutrition Disorder · Obesity

Source: ClinicalTrials.gov NCT00422058 ↗

Enrolled (actual)

564

Serious AEs

8.5%

Results posted

Oct 2010

Primary outcomePrimary: Mean Change From Baseline in Body Weight at Week 20 — 97.3; 96.4; 98.0; 98.4 kg

Summary

This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide. Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Body Weight at Week 20	97.3; 96.4; 98.0; 98.4; 97.5; 96.0	—
SECONDARY Mean Change From Baseline in Body Weight at Week 104	97.3; 96.4; 98.0; 98.4; 97.5; 96.0	—
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 20	5.42; 5.30; 5.29; 5.27; 5.36; 5.3	—
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 104	5.42; 5.30; 5.29; 5.27; 5.36; 5.30	—
SECONDARY Change From Baseline in Fasting Insulin at Week 20	99.5; 82.9; 85.7; 88.7; 89.1; 85.5	—
SECONDARY Change From Baseline in Fasting Insulin at Week 104	99.5; 82.9; 85.7; 88.7; 89.1; 85.5	—
SECONDARY Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20	5.60; 5.58; 5.60; 5.54; 5.57; 5.55	—
SECONDARY Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104	5.60; 5.58; 5.60; 5.54; 5.57; 5.55	—
SECONDARY Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20	3.6; 5.1; 4.4; 4.0; 3.8; 4.6	—
SECONDARY Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104	3.6; 5.1; 4.4; 4.0; 3.8; 4.6	—
SECONDARY Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20	21.6; 19.5; 19.7; 17.6; 19.0; 17.4	—
SECONDARY Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104	21.6; 19.5; 19.7; 17.6; 19.0; 17.4	—
SECONDARY Change From Baseline in Fibrinogen at Week 20	3.60; 3.67; 3.75; 3.64; 3.61; 3.68	—
SECONDARY Change From Baseline in Fibrinogen at Week 104	3.60; 3.67; 3.75; 3.64; 3.61; 3.68	—
SECONDARY Change From Baseline in Adiponectin at Week 20	5.1; 5.8; 6.7; 6.2; 6.1; 5.4	—
SECONDARY Change From Baseline in Adiponectin at Week 104	5.1; 5.8; 6.7; 6.2; 6.1; 5.4	—
SECONDARY Change From Baseline in Waist Circumference at Week 20	108.3; 109.0; 108.2; 110.4; 108.7; 107.6	—
SECONDARY Change From Baseline in Waist Circumference at Week 104	108.3; 109.0; 108.2; 110.4; 108.7; 107.6	—
SECONDARY Change From Baseline in Blood Pressure at Week 20	123.6; 127.2; 123.4; 126.3; 124.3; 122.7	—
SECONDARY Change From Baseline in Blood Pressure at Week 104	123.6; 127.2; 123.4; 126.3; 124.3; 122.7	—

Eligibility Criteria

Inclusion Criteria

Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
Stable body weight (less than 5% selfreported change within the last 3 months)

Exclusion Criteria

Obesity induced by drug treatment
Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
Type 1 or type 2 diabetes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00422058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.