Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

What Was Tested

The trial (phase 3) is built around Liraglutide.

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities.

Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

It had five arms (groups): one (experimental), one (experimental), Liraglutide Placebo, no Pre-diabetes (placebo comparator), one (experimental) and Liraglutide Placebo, Pre-diabetes (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

3731 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained. Body Mass Index (BMI) of 30.0 kg/m\^2 or above. Body Mass Index (BMI) of 27 kg/m\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension. Stable body weight. Preceding failed dietary effort.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: known type 1 or type 2 diabetes; screening calcitonin of 50 ng/l or above; family or personal history of multiple endocrine neoplasia type 2 (men2) or familial medullary thyroid carcinoma (fmtc).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

The Liraglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2011-06-01 with completion listed for 2013-03-18.

It ran at 226 sites in United States (73), Canada (12), Germany (10), India (9), Russia (9) and United Kingdom (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Fasting Body Weight (time frame: Week 0, Week 56). Proportion of Subjects With Onset of Type 2 Diabetes (time frame: At 160 weeks).

It also tracked 8 secondary outcomes, for example Change From Baseline in Waist Circumference (cm), Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline), Pre-diabetes Status After 56 Weeks of Treatment, Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment, Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) and Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 3731 people.

With 3731 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.