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

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: liraglutide; Drug: liraglutide; Drug: placebo; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 3731
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Bs As, Argentina, C1426ABP
    • Novo Nordisk Investigational Site
  • Ciudad Autónoma de BsAs, Argentina, C1406FWY
    • Novo Nordisk Investigational Site
  • Ciudad de Buenos Aires, Argentina, C1405CWB
    • Novo Nordisk Investigational Site
  • Mar del Plata, Argentina, B7600FZN
    • Novo Nordisk Investigational Site
• Australia
  • New South Wales
    • University Of Sydney, New South Wales, Australia, 2006
      • Novo Nordisk Investigational Site
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Novo Nordisk Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5005
      • Novo Nordisk Investigational Site
  • Victoria
    • Heidelberg West, Victoria, Australia, 3081
      • Novo Nordisk Investigational Site
• Austria
  • Graz, Austria, 8036
    • Novo Nordisk Investigational Site
  • Salzburg, Austria, 5020
    • Novo Nordisk Investigational Site
  • Wien, Austria, 1090
    • Novo Nordisk Investigational Site
  • Wien, Austria, 1130
    • Novo Nordisk Investigational Site
• Belgium
  • Boussu, Belgium, 7300
    • Novo Nordisk Investigational Site
  • Edegem, Belgium, 2650
    • Novo Nordisk Investigational Site
  • Liège, Belgium, 4000
    • Novo Nordisk Investigational Site
• Brazil
  • Curitiba, Brazil, 80030-110
    • Novo Nordisk Investigational Site
  • São Paulo, Brazil, 04022-002
    • Novo Nordisk Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
      • Novo Nordisk Investigational Site
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13073-350
      • Novo Nordisk Investigational Site
    • São Paulo, Sao Paulo, Brazil, 05403-000
      • Novo Nordisk Investigational Site
• Canada
  • Quebec, Canada, G1V 4G2
    • Novo Nordisk Investigational Site
  • Quebec, Canada, G1V 4G5
    • Novo Nordisk Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Novo Nordisk Investigational Site
    • Edmonton, Alberta, Canada, T6G 2E1
      • Novo Nordisk Investigational Site
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
      • Novo Nordisk Investigational Site
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Novo Nordisk Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Novo Nordisk Investigational Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 7L6
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8L 2X2
      • Novo Nordisk Investigational Site
    • Ottawa, Ontario, Canada, K1H 1A2
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  • Quebec
    • Pointe Claire, Quebec, Canada, H9R 4S3
      • Novo Nordisk Investigational Site
• Denmark
  • Frederiksberg C, Denmark, 1958
    • Novo Nordisk Investigational Site
  • Hvidovre, Denmark, 2650
    • Novo Nordisk Investigational Site
  • Århus C, Denmark, 8000
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• Finland
  • Kuopio, Finland, 07100
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  • Oulu, Finland, 90220
    • Novo Nordisk Investigational Site
  • University Of Helsinki, Finland, 00014
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• Former Serbia and Montenegro
  • Belgrade, Former Serbia and Montenegro, 11000
    • Novo Nordisk Investigational Site
• France
  • Antibes, France, 06600
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  • Lille, France, 59037
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  • PARIS cedex 13, France, 75651
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  • Paris, France, 75877
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  • Pierre-Bénite, France, 69495
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  • Saint Herblain, France, 44800
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• Germany
  • Bad Nauheim, Germany, 61231
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  • Berlin, Germany, 13055
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  • Dresden, Germany, 01219
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  • Duisburg, Germany, 47051
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  • Freiburg, Germany, 79106
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  • Giessen, Germany, 35392
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  • Gifhorn, Germany, 38518
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  • Leipzig, Germany, 04103
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  • Mannheim, Germany, 68163
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  • Saint Ingbert, Germany, 66386
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• Hong Kong
  • Shatin, New Territories, Hong Kong
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• Hungary
  • Budapest, Hungary, H-1134
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  • Budapest, Hungary, H-1115
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  • Debrecen, Hungary, H-4012
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• India
  • Karnal, India, 132001
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  • Kerala, India, 682026
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  • Karnataka
    • Bangalore, Karnataka, India, 560 017
      • Novo Nordisk Investigational Site
    • Belgaum, Karnataka, India, 590001
      • Novo Nordisk Investigational Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400007
      • Novo Nordisk Investigational Site
    • Mumbai, Maharashtra, India, 4000021
      • Novo Nordisk Investigational Site
    • Mumbai, Maharashtra, India, 400703
      • Novo Nordisk Investigational Site
    • Pune, Maharashtra, India, 411030
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  • Tamil Nadu
    • Trichy, Tamil Nadu, India, 620018
      • Novo Nordisk Investigational Site
• Ireland
  • Dublin, Ireland, DUBLIN 4
    • Novo Nordisk Investigational Site
  • Dublin, Ireland, DUBLIN 8
    • Novo Nordisk Investigational Site
  • Dublin 9, Ireland
    • Novo Nordisk Investigational Site
  • Galway, Ireland, H91 YR71
    • Novo Nordisk Investigational Site
• Israel
  • Haifa, Israel, 31096
    • Novo Nordisk Investigational Site
  • Jerusalem, Israel, 91120
    • Novo Nordisk Investigational Site
  • Kfar Saba, Israel, 44281
    • Novo Nordisk Investigational Site
  • Ofakim, Israel, 87520
    • Novo Nordisk Investigational Site
  • Petah-Tikva, Israel, 49100
    • Novo Nordisk Investigational Site
  • Petah-Tikva, Israel, 49372
    • Novo Nordisk Investigational Site
  • Tel Hashomer, Israel, 52621
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  • Tel-Aviv, Israel, 64239
    • Novo Nordisk Investigational Site
• Italy
  • Bologna, Italy, 40138
    • Novo Nordisk Investigational Site
  • Firenze, Italy, 50139
    • Novo Nordisk Investigational Site
  • Milano, Italy, 20145
    • Novo Nordisk Investigational Site
  • Padova, Italy, 35128
    • Novo Nordisk Investigational Site
  • Palermo, Italy, 90127
    • Novo Nordisk Investigational Site
  • Pisa, Italy, 56124
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  • Roma, Italy, 00168
    • Novo Nordisk Investigational Site
  • Siena, Italy, 53100
    • Novo Nordisk Investigational Site
• Mexico
  • Durango, Mexico, 34000
    • Novo Nordisk Investigational Site
  • Monterrey, Mexico, 64700
    • Novo Nordisk Investigational Site
  • Hidalgo
    • Pachuca, Hidalgo, Mexico, 42084
      • Novo Nordisk Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Novo Nordisk Investigational Site
    • Guadalajara, Jalisco, Mexico, 44650
      • Novo Nordisk Investigational Site
  • México, D.F.
    • Mexico City, México, D.F., Mexico, 03300
      • Novo Nordisk Investigational Site
    • Mexico City, México, D.F., Mexico, 14000
      • Novo Nordisk Investigational Site
  • Tamaulipas
    • Tampico, Tamaulipas, Mexico, 89000
      • Novo Nordisk Investigational Site
• Netherlands
  • Almere, Netherlands, 1311RL
    • Novo Nordisk Investigational Site
  • Amsterdam, Netherlands, 1066 EC
    • Novo Nordisk Investigational Site
  • Beek, Netherlands, 6191JW
    • Novo Nordisk Investigational Site
  • Hengelo OV, Netherlands, 7555 DL
    • Novo Nordisk Investigational Site
  • Hilversum, Netherlands, 1213 RH
    • Novo Nordisk Investigational Site
  • Leidschendam, Netherlands, 2262 BA
    • Novo Nordisk Investigational Site
  • Zwijndrecht, Netherlands, 3331 LZ
    • Novo Nordisk Investigational Site
• Norway
  • Bergen, Norway, NO-5012
    • Novo Nordisk Investigational Site
  • Oslo, Norway, 0424
    • Novo Nordisk Investigational Site
  • Trondheim, Norway, 7030
    • Novo Nordisk Investigational Site
  • Tønsberg, Norway, 3117
    • Novo Nordisk Investigational Site
• Poland
  • Bialystok, Poland, 15-381
    • Novo Nordisk Investigational Site
  • Katowice, Poland, 40-662
    • Novo Nordisk Investigational Site
  • Katowice, Poland, 40-767
    • Novo Nordisk Investigational Site
  • Poznan, Poland, 60-569
    • Novo Nordisk Investigational Site
  • Szczecin, Poland, 71-455
    • Novo Nordisk Investigational Site
  • Szczecin, Poland, 70-483
    • Novo Nordisk Investigational Site
  • Warszawa, Poland, 02-507
    • Novo Nordisk Investigational Site
• Russian Federation
  • Arkhangelsk, Russian Federation, 163045
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 117036
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 121356
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 125367
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 127486
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 101990
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 115093
    • Novo Nordisk Investigational Site
  • Novosibirsk, Russian Federation, 630047
    • Novo Nordisk Investigational Site
  • Tumen, Russian Federation, 625023
    • Novo Nordisk Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novo Nordisk Investigational Site
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Novo Nordisk Investigational Site
    • Pretoria, Gauteng, South Africa, 0083
      • Novo Nordisk Investigational Site
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7130
      • Novo Nordisk Investigational Site
• Spain
  • Almería, Spain, 04001
    • Novo Nordisk Investigational Site
  • Barcelona, Spain, 08036
    • Novo Nordisk Investigational Site
  • Madrid, Spain, 28006
    • Novo Nordisk Investigational Site
  • Santiago de Compostela, Spain, 15706
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41003
    • Novo Nordisk Investigational Site
  • Valladolid, Spain, 47005
    • Novo Nordisk Investigational Site
• Switzerland
  • Baden-Dättwil, Switzerland, 5405
    • Novo Nordisk Investigational Site
  • Bern, Switzerland, 3010
    • Novo Nordisk Investigational Site
  • Genève 14, Switzerland, 1211
    • Novo Nordisk Investigational Site
  • St. Gallen, Switzerland, 9016
    • Novo Nordisk Investigational Site
  • Zollikerberg, Switzerland, 8125
    • Novo Nordisk Investigational Site
• Turkey
  • Ankara, Turkey, 06110
    • Novo Nordisk Investigational Site
  • Ankara, Turkey, 06100
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34098
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34371
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34760
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34668
    • Novo Nordisk Investigational Site
• United Kingdom
  • Coventry, United Kingdom, CV2 2DX
    • Novo Nordisk Investigational Site
  • Glasgow, United Kingdom, G11 6NT
    • Novo Nordisk Investigational Site
  • Hull, United Kingdom, HU3 2RW
    • Novo Nordisk Investigational Site
  • Liverpool, United Kingdom, L9 7AL
    • Novo Nordisk Investigational Site
  • London, United Kingdom, SE1 9RT
    • Novo Nordisk Investigational Site
  • London, United Kingdom, W1T 7DN
    • Novo Nordisk Investigational Site
  • London, United Kingdom, W6 8RF
    • Novo Nordisk Investigational Site
  • Luton, United Kingdom, LU4 0DZ
    • Novo Nordisk Investigational Site
  • Swansea, United Kingdom, SA6 6NL
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205-4731
      • Novo Nordisk Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Novo Nordisk Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Concord, California, United States, 94520
      • Novo Nordisk Investigational Site
    • Huntington Beach, California, United States, 92646
      • Novo Nordisk Investigational Site
    • La Jolla, California, United States, 92037
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92108
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92103-4140
      • Novo Nordisk Investigational Site
    • Santa Monica, California, United States, 90404
      • Novo Nordisk Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Novo Nordisk Investigational Site
    • Colorado Springs, Colorado, United States, 80904
      • Novo Nordisk Investigational Site
    • Golden, Colorado, United States, 80401
      • Novo Nordisk Investigational Site
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Novo Nordisk Investigational Site
    • Waterbury, Connecticut, United States, 06708
      • Novo Nordisk Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20036-5847
      • Novo Nordisk Investigational Site
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Novo Nordisk Investigational Site
    • Bradenton, Florida, United States, 34201
      • Novo Nordisk Investigational Site
    • Crystal River, Florida, United States, 34429
      • Novo Nordisk Investigational Site
    • Daytona Beach, Florida, United States, 32117
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32205
      • Novo Nordisk Investigational Site
    • Ocala, Florida, United States, 34471
      • Novo Nordisk Investigational Site
    • Ponte Vedra, Florida, United States, 32081
      • Novo Nordisk Investigational Site
    • South Miami, Florida, United States, 33143
      • Novo Nordisk Investigational Site
  • Georgia
    • Athens, Georgia, United States, 30606
      • Novo Nordisk Investigational Site
    • Dunwoody, Georgia, United States, 30338
      • Novo Nordisk Investigational Site
    • Sandy Springs, Georgia, United States, 30328
      • Novo Nordisk Investigational Site
    • Suwanee, Georgia, United States, 30024
      • Novo Nordisk Investigational Site
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Novo Nordisk Investigational Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Novo Nordisk Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4124
      • Novo Nordisk Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Novo Nordisk Investigational Site
    • Elkridge, Maryland, United States, 21075-6437
      • Novo Nordisk Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Novo Nordisk Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Novo Nordisk Investigational Site
    • Saint Louis, Missouri, United States, 63141
      • Novo Nordisk Investigational Site
    • Saint Louis, Missouri, United States, 63104
      • Novo Nordisk Investigational Site
    • Saint Peters, Missouri, United States, 63376
      • Novo Nordisk Investigational Site
  • New York
    • New York, New York, United States, 10025
      • Novo Nordisk Investigational Site
    • Rochester, New York, United States, 14609
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    • Staten Island, New York, United States, 10301
      • Novo Nordisk Investigational Site
    • Syracuse, New York, United States, 13210
      • Novo Nordisk Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Novo Nordisk Investigational Site
    • Raleigh, North Carolina, United States, 27612
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  • Ohio
    • Canal Fulton, Ohio, United States, 44614
      • Novo Nordisk Investigational Site
    • Cincinnati, Ohio, United States, 45219
      • Novo Nordisk Investigational Site
    • Franklin, Ohio, United States, 45005
      • Novo Nordisk Investigational Site
    • Wadsworth, Ohio, United States, 44281-9236
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Novo Nordisk Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
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  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
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    • Philadelphia, Pennsylvania, United States, 19107
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    • Pittsburgh, Pennsylvania, United States, 15206
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    • West Reading, Pennsylvania, United States, 19611
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  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Novo Nordisk Investigational Site
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620-7352
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  • Texas
    • Austin, Texas, United States, 78731
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75231
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75390-8858
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75251
      • Novo Nordisk Investigational Site
    • Dallas, Texas, United States, 75234
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    • San Antonio, Texas, United States, 78229-4801
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77479
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  • Utah
    • Salt Lake City, Utah, United States, 84107
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    • West Jordan, Utah, United States, 84088-8871
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  • Virginia
    • Arlington, Virginia, United States, 22206
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    • Henrico, Virginia, United States, 23233
      • Novo Nordisk Investigational Site
    • Richmond, Virginia, United States, 23294
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    • Virginia Beach, Virginia, United States, 23454
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  • Washington
    • Renton, Washington, United States, 98057
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    • Wenatchee, Washington, United States, 98801-2028
      • Novo Nordisk Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	Drug: liraglutide; 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).; Drug: liraglutide; Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
Experimental: Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	Drug: placebo; 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).; Drug: placebo; Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
Placebo Comparator: Liraglutide Placebo, no Pre-diabetes	Drug: placebo; 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).; Drug: placebo; Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
Experimental: Liraglutide 3.0mg, Pre-diabetes	Drug: liraglutide; 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).; Drug: liraglutide; Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
Placebo Comparator: Liraglutide Placebo, Pre-diabetes	Drug: placebo; 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).; Drug: placebo; Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Body Weight	The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).	Week 0, Week 56
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.	Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).	At Week 56
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight	Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).	At 56 weeks
Proportion of Subjects With Onset of Type 2 Diabetes	Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	At 160 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Waist Circumference (cm)	The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).	Week 0, Week 56
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)	The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	Week 0, week 160
Pre-diabetes Status After 56 Weeks of Treatment	Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).	Week 0, Week 56
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment	Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	Week 0, week 160
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)	The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	Week 0, week 160
Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)	Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).	At 160 weeks
Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)	The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).	Week 56, Week 68
Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)	The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).	Week 0, Week 68

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Global Clinical Registry GCR, 1452, Novo Nordisk A/S

Publications and helpful links

General Publications

• Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.
• Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.
• O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.
• Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.
• Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.
• Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.
• Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.
• McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
• von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.
• O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
• Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
• Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19.
• le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjoth TV, Manning LS, Pi-Sunyer X; SCALE Obesity Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23. Erratum In: Lancet. 2017 Apr 8;389(10077):1398.
• Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujioka K. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2018 Feb;8(1):1-10. doi: 10.1111/cob.12226. Epub 2017 Oct 16.
• le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.
• Williams DM, Staff M, Bain SC, Min T. Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity. touchREV Endocrinol. 2022 Mar;18(1):43-48. doi: 10.17925/EE.2022.18.1.43. Epub 2022 Mar 18.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2011
• Primary Completion (Actual): March 18, 2013
• Study Completion (Actual): March 2, 2015

Study Registration Dates

• First Submitted: January 6, 2011
• First Submitted That Met QC Criteria: January 6, 2011
• First Posted (Estimate): January 7, 2011

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Obesity; Prediabetic State; Overweight; Body Weight; Nutrition Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN8022-1839; 2008-001049-24 (EudraCT Number); U1111-1118-7871 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No