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

NCT01272219 · Completed

Last updated 2026-05-28

This clinical trial tested the effect of the medication liraglutide on body weight in adults who are obese or overweight with weight-related health conditions but do not have diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 3,731 people

Who can join Ages 18+ · all sexes

Timeline Started 2011-06 · est. completion 2015-03

Where 226 sites · Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russia, Serbia, Serbia and Montenegro, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01272219 ↗

Description as written by the study sponsor.

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. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Treatments tested

liraglutide Drug

Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
placebo Drug

Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
liraglutide Drug

Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
placebo Drug

Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

Main thing measured	Change From Baseline in Fasting Body Weight
Sponsor	Novo Nordisk A/S
Conditions studied	Metabolism and Nutrition Disorder, Obesity
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01272219 ↗