Metabolism and Nutrition DisorderPhase 3NCT01272219

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

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 226 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metabolism and Nutrition Disorder, Obesity
What is being tested?: liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,731 participants
Where: 226 sitesin 29 countries
Study dates: 1 Jun 2011to 2 Mar 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to 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

Who cannot join

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

Show all 11Show fewer

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)

Trial locations and contacts

226 sites in 29 countries.

Country

City, postcode or hospital

226 sites in 29 countries

United States73 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Arlington, Virginia, 22206
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Aurora, Illinois, 60504
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Baltimore, Maryland, 21209
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, 70808-4124
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Birmingham, Alabama, 35205-4731
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33437
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620-7352
Novo Nordisk Investigational Site
Canal Fulton, Ohio, 44614
Novo Nordisk Investigational Site
Cary, North Carolina, 27518
Novo Nordisk Investigational Site
Charleston, South Carolina, 29425
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45219
Novo Nordisk Investigational Site
City of Saint Peters, Missouri, 63376
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80904
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Crystal River, Florida, 34429
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75234
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Daytona Beach, Florida, 32117
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Elkridge, Maryland, 21075-6437
Novo Nordisk Investigational Site
Eugene, Oregon, 97401
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Golden, Colorado, 80401
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Henrico, Virginia, 23233
Novo Nordisk Investigational Site
Huntington Beach, California, 92646
Novo Nordisk Investigational Site
Jacksonville, Florida, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Kansas City, Missouri, 64111
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
New London, Connecticut, 06320
Novo Nordisk Investigational Site
New York, New York, 10025
Novo Nordisk Investigational Site
North Dartmouth, Massachusetts, 02747
Novo Nordisk Investigational Site
Ocala, Florida, 34471
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Phoenix, Arizona, 85027
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15206
Novo Nordisk Investigational Site
Ponte Vedra, Florida, 32081
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27612
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Richmond, Virginia, 23294
Novo Nordisk Investigational Site
Rochester, New York, 14609
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Antonio, Texas, 78229-4801
Novo Nordisk Investigational Site
San Diego, California, 92103-4140
Novo Nordisk Investigational Site
San Diego, California, 92108
Novo Nordisk Investigational Site
Sandy Springs, Georgia, 30328
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
South Miami, Florida, 33143
Novo Nordisk Investigational Site
St Louis, Missouri, 63104
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Suwanee, Georgia, 30024
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74136
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23454
Novo Nordisk Investigational Site
Wadsworth, Ohio, 44281-9236
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, 20036-5847
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
Wenatchee, Washington, 98801-2028
Novo Nordisk Investigational Site
West Jordan, Utah, 84088-8871
Novo Nordisk Investigational Site
West Reading, Pennsylvania, 19611

Other trials in United States

Canada12 sites

Novo Nordisk Investigational Site
Calgary, Alberta, T2T 5C7
Novo Nordisk Investigational Site
Cambridge, Ontario, N1R 7L6
Novo Nordisk Investigational Site
Edmonton, Alberta, T6G 2E1
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 2Y9
Novo Nordisk Investigational Site
Hamilton, Ontario, L8L 2X2
Novo Nordisk Investigational Site
Hamilton, Ontario, L8M 1K7
Novo Nordisk Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Novo Nordisk Investigational Site
Ottawa, Ontario, K1H 1A2
Novo Nordisk Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Novo Nordisk Investigational Site
Québec, G1V 4G2
Novo Nordisk Investigational Site
Québec, G1V 4G5
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5

Other trials in Canada

Germany10 sites

Novo Nordisk Investigational Site
Bad Nauheim, 61231
Novo Nordisk Investigational Site
Berlin, 13055
Novo Nordisk Investigational Site
Dresden, 01219
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Freiburg im Breisgau, 79106
Novo Nordisk Investigational Site
Giessen, 35392
Novo Nordisk Investigational Site
Gifhorn, 38518
Novo Nordisk Investigational Site
Leipzig, 04103
Novo Nordisk Investigational Site
Mannheim, 68163
Novo Nordisk Investigational Site
Saint Ingbert, 66386

Other trials in Germany

India9 sites

Novo Nordisk Investigational Site
Bangalore, Karnataka, 560 017
Novo Nordisk Investigational Site
Belagavi, Karnataka, 590001
Novo Nordisk Investigational Site
Karnāl, 132001
Novo Nordisk Investigational Site
Kerala, 682026
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 4000021
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400007
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400703
Novo Nordisk Investigational Site
Pune, Maharashtra, 411030
Novo Nordisk Investigational Site
Trichy, Tamil Nadu, 620018

Other trials in India

Russia9 sites

Novo Nordisk Investigational Site
Arkhangelsk, 163045
Novo Nordisk Investigational Site
Moscow, 101990
Novo Nordisk Investigational Site
Moscow, 115093
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 121356
Novo Nordisk Investigational Site
Moscow, 125367
Novo Nordisk Investigational Site
Moscow, 127486
Novo Nordisk Investigational Site
Novosibirsk, 630047
Novo Nordisk Investigational Site
Tyumen, 625023

Other trials in Russia

United Kingdom9 sites

Novo Nordisk Investigational Site
Coventry, CV2 2DX
Novo Nordisk Investigational Site
Glasgow, G11 6NT
Novo Nordisk Investigational Site
Hull, HU3 2RW
Novo Nordisk Investigational Site
Liverpool, L9 7AL
Novo Nordisk Investigational Site
London, SE1 9RT
Novo Nordisk Investigational Site
London, W1T 7DN
Novo Nordisk Investigational Site
London, W6 8RF
Novo Nordisk Investigational Site
Luton, LU4 0DZ
Novo Nordisk Investigational Site
Swansea, SA6 6NL

Other trials in United Kingdom

Israel8 sites

Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Ofakim, 87520
Novo Nordisk Investigational Site
Petah Tikva, 49100
Novo Nordisk Investigational Site
Petah Tikva, 49372
Novo Nordisk Investigational Site
Tel Aviv, 64239
Novo Nordisk Investigational Site
Tel HaShomer, 52621

Other trials in Israel

Italy8 sites

Novo Nordisk Investigational Site
Bologna, 40138
Novo Nordisk Investigational Site
Florence, 50139
Novo Nordisk Investigational Site
Milan, 20145
Novo Nordisk Investigational Site
Padova, 35128
Novo Nordisk Investigational Site
Palermo, 90127
Novo Nordisk Investigational Site
Pisa, 56124
Novo Nordisk Investigational Site
Roma, 00168
Novo Nordisk Investigational Site
Siena, 53100

Other trials in Italy

Mexico8 sites

Novo Nordisk Investigational Site
Durango, 34000
Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44600
Novo Nordisk Investigational Site
Guadalajara, Jalisco, 44650
Novo Nordisk Investigational Site
Mexico City, México, D.F., 03300
Novo Nordisk Investigational Site
Mexico City, México, D.F., 14000
Novo Nordisk Investigational Site
Monterrey, 64700
Novo Nordisk Investigational Site
Pachuca, Hidalgo, 42084
Novo Nordisk Investigational Site
Tampico, Tamaulipas, 89000

Other trials in Mexico

Netherlands7 sites

Novo Nordisk Investigational Site
Almere Stad, 1311RL
Novo Nordisk Investigational Site
Amsterdam, 1066 EC
Novo Nordisk Investigational Site
Beek, 6191JW
Novo Nordisk Investigational Site
Hengelo OV, 7555 DL
Novo Nordisk Investigational Site
Hilversum, 1213 RH
Novo Nordisk Investigational Site
Leidschendam, 2262 BA
Novo Nordisk Investigational Site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

Poland7 sites

Novo Nordisk Investigational Site
Bialystok, 15-381
Novo Nordisk Investigational Site
Katowice, 40-662
Novo Nordisk Investigational Site
Katowice, 40-767
Novo Nordisk Investigational Site
Poznan, 60-569
Novo Nordisk Investigational Site
Szczecin, 70-483
Novo Nordisk Investigational Site
Szczecin, 71-455
Novo Nordisk Investigational Site
Warsaw, 02-507

Other trials in Poland

France6 sites

Novo Nordisk Investigational Site
Antibes, 06600
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Paris, 75651
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Pierre-Bénite, 69495
Novo Nordisk Investigational Site
Saint-Herblain, 44800

Other trials in France

Spain6 sites

Novo Nordisk Investigational Site
Almería, 04001
Novo Nordisk Investigational Site
Barcelona, 08036
Novo Nordisk Investigational Site
Madrid, 28006
Novo Nordisk Investigational Site
Santiago de Compostela, 15706
Novo Nordisk Investigational Site
Seville, 41003
Novo Nordisk Investigational Site
Valladolid, 47005

Other trials in Spain

Turkey (Türkiye)6 sites

Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Ankara, 06110
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34371
Novo Nordisk Investigational Site
Istanbul, 34668
Novo Nordisk Investigational Site
Istanbul, 34760

Other trials in Turkey (Türkiye)

Brazil5 sites

Novo Nordisk Investigational Site
Campinas, São Paulo, 13073-350
Novo Nordisk Investigational Site
Curitiba, 80030-110
Novo Nordisk Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170
Novo Nordisk Investigational Site
São Paulo, São Paulo, 05403-000
Novo Nordisk Investigational Site
São Paulo, 04022-002

Other trials in Brazil

Switzerland5 sites

Novo Nordisk Investigational Site
Bern, 3010
Novo Nordisk Investigational Site
Dättwil, 5405
Novo Nordisk Investigational Site
Geneva, 1211
Novo Nordisk Investigational Site
Sankt Gallen, 9016
Novo Nordisk Investigational Site
Zollikerberg, 8125

Other trials in Switzerland

Argentina4 sites

Novo Nordisk Investigational Site
Ciudad Autónoma de Bs As, C1426ABP
Novo Nordisk Investigational Site
Ciudad Autónoma de BsAs, C1406FWY
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, C1405CWB
Novo Nordisk Investigational Site
Mar del Plata, B7600FZN

Other trials in Argentina

Australia4 sites

Novo Nordisk Investigational Site
Adelaide, South Australia, 5005
Novo Nordisk Investigational Site
Heidelberg West, Victoria, 3081
Novo Nordisk Investigational Site
University of Sydney, New South Wales, 2006
Novo Nordisk Investigational Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Austria4 sites

Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Salzburg, 5020
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, 1130

Other trials in Austria

Ireland4 sites

Novo Nordisk Investigational Site
Dublin, DUBLIN 4
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Dublin
Novo Nordisk Investigational Site
Galway, H91 YR71

Other trials in Ireland

Norway4 sites

Novo Nordisk Investigational Site
Bergen, NO-5012
Novo Nordisk Investigational Site
Oslo, 0424
Novo Nordisk Investigational Site
Tønsberg, 3117
Novo Nordisk Investigational Site
Trondheim, 7030

Other trials in Norway

Belgium3 sites

Novo Nordisk Investigational Site
Boussu, 7300
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Liège, 4000

Other trials in Belgium

Denmark3 sites

Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Frederiksberg C, 1958
Novo Nordisk Investigational Site
Hvidovre, 2650

Other trials in Denmark

Finland3 sites

Novo Nordisk Investigational Site
Kuopio, 07100
Novo Nordisk Investigational Site
Oulu, 90220
Novo Nordisk Investigational Site
University of Helsinki, 00014

Other trials in Finland

Hungary3 sites

Novo Nordisk Investigational Site
Budapest, H-1115
Novo Nordisk Investigational Site
Budapest, H-1134
Novo Nordisk Investigational Site
Debrecen, H-4012

Other trials in Hungary

South Africa3 sites

Novo Nordisk Investigational Site
Cape Town, Western Cape, 7130
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0083

Other trials in South Africa

Hong Kong1 site

Novo Nordisk Investigational Site
Shatin, New Territories

Other trials in Hong Kong

Serbia and Montenegro1 site

Novo Nordisk Investigational Site
Belgrade, 11000

Other trials in Serbia and Montenegro

Serbia1 site

Novo Nordisk Investigational Site
Belgrade, 11000

Other trials in Serbia

About this study

Official title: 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).

Conditions: Metabolism and Nutrition Disorder, Obesity
Being tested: liraglutide, placebo
Medical subject headings: Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01272219
Study group	Role	What they receive
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	Experimental	Not described Receives: Drug: liraglutide
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	Experimental	Not described Receives: Drug: placebo
Liraglutide Placebo, no Pre-diabetes	Placebo comparator	Not described Receives: Drug: placebo
Liraglutide 3.0mg, Pre-diabetes	Experimental	Not described Receives: Drug: liraglutide
Liraglutide Placebo, Pre-diabetes	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 160 weeks

Secondary outcomes (8)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Week 0, Week 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20112 Mar 2015

First posted7 Jan 2011 (estimated)
Study start1 Jun 2011
Primary completion18 Mar 2013
Study completion2 Mar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,731 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272219
Sponsor's protocol ID: NN8022-1839
Other IDs: 2008-001049-24, U1111-1118-7871, 2008
Status last verified: Dec 2017
First submitted: 6 Jan 2011
Last updated: 19 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 27198973
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.
PubMed 27193270
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.
PubMed 27482610
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.
PubMed 27804269
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.
PubMed 27817208
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.
PubMed 26833744
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.
PubMed 26132939
McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
PubMed 26418188
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.
PubMed 26744025
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.
PubMed 28237263
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.
PubMed 28462892
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.
PubMed 28386912
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.
PubMed 28950422
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.
PubMed 29045079
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.
PubMed 29145215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
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Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01272219
Acronym / sponsor ID: NN8022-1839
Conditions: Metabolism and Nutrition Disorder, Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,731 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 1 Jun 2011 (actual)
Primary completion: 18 Mar 2013 (actual)
Study completion: 2 Mar 2015 (actual)
First posted: 7 Jan 2011 (estimated)
Results: Posted 9 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	Experimental	Drug: liraglutide
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	Experimental	Drug: placebo
Liraglutide Placebo, no Pre-diabetes	Placebo comparator	Drug: placebo
Liraglutide 3.0mg, Pre-diabetes	Experimental	Drug: liraglutide
Liraglutide Placebo, Pre-diabetes	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutideSubject 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 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
placeboSubject 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	Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68), Liraglutide Placebo, no Pre-diabetes
liraglutideLiraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.	Drug	Liraglutide 3.0mg, Pre-diabetes
placeboLiraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.	Drug	Liraglutide Placebo, Pre-diabetes

Primary outcome

Change From Baseline in Fasting Body Weight
Time frame: Week 0, Week 56
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Time frame: At Week 56
Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
Time frame: At 56 weeks
Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Proportion of Subjects With Onset of Type 2 Diabetes
Time frame: At 160 weeks
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).

8 secondary outcomes

Change From Baseline in Waist Circumference (cm)
Time frame: Week 0, Week 56
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
Time frame: Week 0, week 160
Pre-diabetes Status After 56 Weeks of Treatment
Time frame: Week 0, Week 56
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
Time frame: Week 0, week 160
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Time frame: 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)
Time frame: At 160 weeks
Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
Time frame: Week 56, Week 68
Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
Time frame: Week 0, Week 68

Results and safety

Results posted to the registry on 9 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide 3.0 mg, no Pre-diabetes	959	679
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	0	0
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	0	0
Liraglutide Placebo, no Pre-diabetes	487	296
Liraglutide 3.0 mg, Pre-diabetes	1,528	1,110
Liraglutide Placebo, Pre-diabetes	757	505

Primary outcome: Change From Baseline in Fasting Body Weight

Time frame: Week 0, Week 56. Mean (Standard Deviation). Unit: percent change

Measure	Liraglutide 3.0 mg (56-Week) n = 2432	Liraglutide Placebo (56-Week) n = 1220
Value	-7.98 (6.67)	-2.62 (5.74)

Liraglutide 3.0 mg (56-Week) vs Liraglutide Placebo (56-Week): Estimated mean difference: -5.39 (95% CI -5.82 to -4.95), p <0.0001, ANCOVA

Population analysed: The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).

Primary outcome: Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Time frame: At Week 56. Number. Unit: percentage of subjects

Measure	Liraglutide 3.0 mg (56-Week) n = 2432	Liraglutide Placebo (56-Week) n = 1220
Value	63.2	27.1

Liraglutide 3.0 mg (56-Week) vs Liraglutide Placebo (56-Week): Odds Ratio (OR): 4.80 (95% CI 4.12 to 5.60), p <0.0001, Regression, Logistic

Population analysed: The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.

Primary outcome: Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight

Time frame: At 56 weeks. Number. Unit: percentage of subjects

Measure	Liraglutide 3.0 mg (56-Week) n = 2432	Liraglutide Placebo (56-Week) n = 1220
Value	33.1	10.6

Liraglutide 3.0 mg (56-Week) vs Liraglutide Placebo (56-Week): Odds Ratio (OR): 4.34 (95% CI 3.54 to 5.32), p <0.0001, Regression, Logistic

Population analysed: The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.

Primary outcome: Proportion of Subjects With Onset of Type 2 Diabetes

Time frame: At 160 weeks. Number. Unit: Subject

Measure	Liraglutide 3.0 mg (160-Week) n = 1472	Liraglutide Placebo (160-Week) n = 738
Value	26	46

Liraglutide 3.0 mg (160-Week) vs Liraglutide Placebo (160-Week): Treatment estimate: 2.681 (95% CI 1.856 to 3.872), p <.0001, Weibull analysis

Population analysed: Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: For Arm 1 and Arm 2: week 0 to week 70 (68 weeks of treatment period + 2 weeks of follow-up). For Arm 3 and Arm 4: week 0 to week 172 (160 weeks of treatment period + 12 weeks of follow-up).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide 3.0 mg, Pre-diabetes	230 of 1,524 (15.1%)	1,342 of 1,524 (88.1%)	Not reported
Liraglutide Placebo, Pre-diabetes	96 of 755 (12.7%)	586 of 755 (77.6%)	Not reported
Liraglutide 3.0 mg, no Pre-diabetes	59 of 957 (6.2%)	843 of 957 (88.1%)	Not reported
Liraglutide Placebo, no Pre-diabetes	19 of 487 (3.9%)	345 of 487 (70.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27198973Kolotkin 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.
Results publication: PubMed 27193270Overgaard 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.
Results publication: PubMed 27482610O'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.
Results publication: PubMed 27804269Fujioka 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.
Results publication: PubMed 27817208Bays 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.
Results publication: PubMed 26833744Wilding 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.
Results publication: PubMed 26132939Pi-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.
Results publication: PubMed 26418188McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
Results publication: PubMed 26744025Ard 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.
Results publication: PubMed 28237263le 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.
Results publication: PubMed 28462892von 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.
Results publication: PubMed 28386912O'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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry GCR, 1452 study director

Novo Nordisk A/S

226 sites in 29 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 226 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Canada, Germany, India, Russia and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Fasting Body Weight (time frame: Week 0, Week 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272219, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.