Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001049-24-IE

Enrollment

3600

Registered

2008-09-15

Start date

2008-12-02

Completion date

Unknown

Last updated

2017-01-09

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

Conditions

Obesity and overweight Pre-diabetes MedDRA version: 14.1 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Victoza® Pharmaceutical Form: Solution for injection INN or Proposed INN: liraglutide CAS Number: 204656-20-2 Other descriptive name: NNC90-1170 Concentration unit: mg/ml milligram(s)/mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Informed consent obtained • Body Mass Index (BMI) = 30.0 kg/m2 or = 27 kg/m2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia) • Stable body weight • Preceding failed dietary effort Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Known type 1 or type 2 diabetes • HbA1c = 6.5 % (Screening visit 1) or FPG = 126 mg/dL (7 mmol/L) (Screening visit 2) or 2 hr post-challenge (OGTT) plasma glucose =200 mg/dL (11.1 mmol/L) (Screening visit 2) • Screening calcitonin = 50 ng/L • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) • Personal history of non-familial medullary thyroid carcinoma • History of acute or chronic pancreatitis • Obesity induced by drug treatment • Use of approved weight lowering pharmacotherapy • Previous surgical treatment of obesity • History of major depressive disorder or suicide attempt

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish the efficacy of 3.0 mg liraglutide compared to liraglutide placebo in inducing and maintaining weight loss over 56 weeks in obese subjects and overweight subjects with comorbidities To investigate the long term efficacy of 3.0 mg liraglutide versus liraglutide placebo in delaying the onset of type 2 diabetes in obese subjects and overweight subjects with co-morbidities diagnosed with pre-diabetes ;Secondary Objective: To investigate the long term efficacy of 3.0 mg liraglutide versus liraglutide placebo on cardiovascular risk markers such as blood pressure, lipids, glucose parameters, urinary-albumin-to-creatinine-ratio (UACR) as well as effects on quality of life, Patient Reported Outcomes (PRO) and Binge Eating Scale (BES) ratings ;Primary end point(s): • Change from baseline in body weight (fasting) at 56 weeks • Proportion of subjects losing at least 5% of baseline body weight at 56 weeks • Proportion of subjects losing more than 10% of baseline body weight at 56 weeks • Proportion of subjects with onset of type 2 diabetes at 160 weeks (among subjects with prediabetes at baseline)	—

Measure

Time frame

Main Objective: To establish the efficacy of 3.0 mg liraglutide compared to liraglutide placebo in inducing and maintaining weight loss over 56 weeks in obese subjects and overweight subjects with comorbidities To investigate the long term efficacy of 3.0 mg liraglutide versus liraglutide placebo in delaying the onset of type 2 diabetes in obese subjects and overweight subjects with co-morbidities diagnosed with pre-diabetes ;Secondary Objective: To investigate the long term efficacy of 3.0 mg liraglutide versus liraglutide placebo on cardiovascular risk markers such as blood pressure, lipids, glucose parameters, urinary-albumin-to-creatinine-ratio (UACR) as well as effects on quality of life, Patient Reported Outcomes (PRO) and Binge Eating Scale (BES) ratings ;Primary end point(s): • Change from baseline in body weight (fasting) at 56 weeks • Proportion of subjects losing at least 5% of baseline body weight at 56 weeks • Proportion of subjects losing more than 10% of baseline body weight at 56 weeks • Proportion of subjects with onset of type 2 diabetes at 160 weeks (among subjects with prediabetes at baseline)

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Countries

Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026