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

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: 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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002199

Enrollment

3600

Registered

2011-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Obesity Health Condition 2: E65-E68- Overweight, obesity and other hyperalimentation Health Condition 3: E65-E68- Overweight, obesity and other hyperalimentation

Interventions

Intervention1: Liraglutide, no pre-diabetes (Experimental):: Drug: liraglutide. Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks. After 56 weeks, subjects will be

Eligibility

Inclusion criteria

Inclusion criteria: Informed consent obtained Body Mass Index (BMI) of 30.0 kg/m2 or above Body Mass Index (BMI) of 27 kg/m2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension Stable body weight Preceding failed dietary effort Note-this trial has no upper age limit

Exclusion criteria

Exclusion criteria: Known type 1 or type 2 diabetes Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2) 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) 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 Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

Design outcomes

Primary

Measure	Time frame
Change from baseline in body weight (fasting)Timepoint: 56 weeks;Change from baseline in body weight (fasting)Timepoint: 56 weeks;Change from baseline in body weight (fasting)Timepoint: 56 weeks;Change from baseline in body weight (fasting)Timepoint: 56 weeks	—

Secondary

Measure	Time frame
Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes)Timepoint: 56 week and 68 week;Change from baseline in pre-diabetes statusTimepoint: 56 weeks;Change from baseline in pre-diabetes status (subjects with pre-diabetes at baseline)Timepoint: 160 week;Change from baseline in waist circumferenceTimepoint: 56 week;Change from baseline in waist circumference (subjects with pre-diabetes at baseline)Timepoint: 160 week;Mean change from baseline in body weight (subjects with pre-diabetes at baseline)Timepoint: 160 week;Proportion of subjects losing at least 5% and more than 10% of baseline body weight (subjects with pre-diabetes at baseline)Timepoint: 160 week	—

Measure

Time frame

Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes)Timepoint: 56 week and 68 week;Change from baseline in pre-diabetes statusTimepoint: 56 weeks;Change from baseline in pre-diabetes status (subjects with pre-diabetes at baseline)Timepoint: 160 week;Change from baseline in waist circumferenceTimepoint: 56 week;Change from baseline in waist circumference (subjects with pre-diabetes at baseline)Timepoint: 160 week;Mean change from baseline in body weight (subjects with pre-diabetes at baseline)Timepoint: 160 week;Proportion of subjects losing at least 5% and more than 10% of baseline body weight (subjects with pre-diabetes at baseline)Timepoint: 160 week

—

Countries

Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Other, Poland, Russian Federation, Serbia, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States of America

Contacts

Public ContactMr Avik Gosh

Novo Nordisk India Private Ltd.

rasy@novonordisk.com918040303200

Outcome results

None listed

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