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

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

liraglutide

placebo

liraglutide

placebo

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

Liraglutide Placebo, no Pre-diabetes

Liraglutide 3.0mg, Pre-diabetes

Liraglutide Placebo, Pre-diabetes

Arm Description

Outcomes

Primary Outcome Measures

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).

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).

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).

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).

Secondary Outcome Measures

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).

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).

Pre-diabetes Status After 56 Weeks of Treatment

Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).

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).

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).

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).

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).

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).

Full Information

NCT ID

NCT01272219

First Posted

January 6, 2011

Last Updated

December 20, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01272219

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

June 1, 2011 (Actual)

Primary Completion Date

March 18, 2013 (Actual)

Study Completion Date

March 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3731 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

Arm Type

Experimental

Arm Title

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

Arm Type

Experimental

Arm Title

Liraglutide Placebo, no Pre-diabetes

Arm Type

Placebo Comparator

Arm Title

Liraglutide 3.0mg, Pre-diabetes

Arm Type

Experimental

Arm Title

Liraglutide Placebo, Pre-diabetes

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Fasting Body Weight

Description

The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).

Time Frame

Week 0, Week 56

Title

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

Description

Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).

Time Frame

At Week 56

Title

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

Description

Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).

Time Frame

At 56 weeks

Title

Proportion of Subjects With Onset of Type 2 Diabetes

Description

Time Frame

At 160 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Waist Circumference (cm)

Description

The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).

Time Frame

Week 0, Week 56

Title

Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

Description

Time Frame

Week 0, week 160

Title

Pre-diabetes Status After 56 Weeks of Treatment

Description

Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).

Time Frame

Week 0, Week 56

Title

Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment

Description

Time Frame

Week 0, week 160

Title

Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Description

Time Frame

Week 0, week 160

Title

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)

Description

Time Frame

At 160 weeks

Title

Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

Description

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).

Time Frame

Week 56, Week 68

Title

Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

Description

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).

Time Frame

Week 0, Week 68

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry GCR, 1452

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205-4731

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103-4140

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80904

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20036-5847

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33437

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dunwoody

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sandy Springs

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Suwanee

State/Province

Georgia

ZIP/Postal Code

30024

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Aurora

State/Province

Illinois

ZIP/Postal Code

60504

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808-4124

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21209

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075-6437

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10301

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Canal Fulton

State/Province

Ohio

ZIP/Postal Code

44614

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Franklin

State/Province

Ohio

ZIP/Postal Code

45005

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281-9236

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620-7352

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8858

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-4801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088-8871

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Henrico

State/Province

Virginia

ZIP/Postal Code

23233

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801-2028

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ciudad Autónoma de Bs As

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Ciudad Autónoma de BsAs

ZIP/Postal Code

C1406FWY

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Ciudad de Buenos Aires

ZIP/Postal Code

C1405CWB

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Mar del Plata

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

University Of Sydney

State/Province

New South Wales

ZIP/Postal Code

2006

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5005

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Boussu

ZIP/Postal Code

7300

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-170

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13073-350

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Curitiba

ZIP/Postal Code

80030-110

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

ZIP/Postal Code

04022-002

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2T 5C7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2E1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Mount Pearl

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1N 1W7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 3R5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

State/Province

Ontario

ZIP/Postal Code

N1R 7L6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8M 1K7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Pointe Claire

State/Province

Quebec

ZIP/Postal Code

H9R 4S3

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Frederiksberg C

ZIP/Postal Code

1958

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Århus C

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Kuopio

ZIP/Postal Code

07100

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

University Of Helsinki

ZIP/Postal Code

00014

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Former Serbia and Montenegro

Facility Name

Novo Nordisk Investigational Site

City

Antibes

ZIP/Postal Code

06600

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Novo Nordisk Investigational Site

City

PARIS cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75877

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Saint Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01219

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Duisburg

ZIP/Postal Code

47051

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Gifhorn

ZIP/Postal Code

38518

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Mannheim

ZIP/Postal Code

68163

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Saint Ingbert

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

H-1115

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

H-1134

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Debrecen

ZIP/Postal Code

H-4012

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 017

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Belgaum

State/Province

Karnataka

ZIP/Postal Code

590001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

4000021

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400007

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400703

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411030

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Trichy

State/Province

Tamil Nadu

ZIP/Postal Code

620018

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Karnal

ZIP/Postal Code

132001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kerala

ZIP/Postal Code

682026

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Dublin 9

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 4

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 8

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Galway

ZIP/Postal Code

H91 YR71

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Ofakim

ZIP/Postal Code

87520

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah-Tikva

ZIP/Postal Code

49372

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20145

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Pachuca

State/Province

Hidalgo

ZIP/Postal Code

42084

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44600

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Mexico City

State/Province

México, D.F.

ZIP/Postal Code

03300

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Mexico City

State/Province

México, D.F.

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Tampico

State/Province

Tamaulipas

ZIP/Postal Code

89000

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Monterrey

ZIP/Postal Code

64700

Country

Mexico

Facility Name

Novo Nordisk Investigational Site

City

Almere

ZIP/Postal Code

1311RL

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Amsterdam

ZIP/Postal Code

1066 EC

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Beek

ZIP/Postal Code

6191JW

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Hengelo OV

ZIP/Postal Code

7555 DL

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Hilversum

ZIP/Postal Code

1213 RH

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Leidschendam

ZIP/Postal Code

2262 BA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Zwijndrecht

ZIP/Postal Code

3331 LZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Bergen

ZIP/Postal Code

NO-5012

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Trondheim

ZIP/Postal Code

7030

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Tønsberg

ZIP/Postal Code

3117

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-381

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Katowice

ZIP/Postal Code

40-662

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Katowice

ZIP/Postal Code

40-767

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

70-483

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

71-455

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

121356

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

127486

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630047

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0083

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Almería

ZIP/Postal Code

04001

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41003

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valladolid

ZIP/Postal Code

47005

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Baden-Dättwil

ZIP/Postal Code

5405

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Genève 14

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

St. Gallen

ZIP/Postal Code

9016

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Zollikerberg

ZIP/Postal Code

8125

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Ankara

ZIP/Postal Code

06110

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34371

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34668

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34760

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Glasgow

ZIP/Postal Code

G11 6NT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hull

ZIP/Postal Code

HU3 2RW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

W1T 7DN

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Luton

ZIP/Postal Code

LU4 0DZ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Swansea

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27198973

Citation

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.

Results Reference

result

PubMed Identifier

27193270

Citation

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.

Results Reference

result

PubMed Identifier

27482610

Citation

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.

Results Reference

result

PubMed Identifier

27804269

Citation

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.

Results Reference

result

PubMed Identifier

27817208

Citation

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.

Results Reference

result

PubMed Identifier

26833744

Citation

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.

Results Reference

result

PubMed Identifier

26132939

Citation

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.

Results Reference

result

PubMed Identifier

26418188

Citation

McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.

Results Reference

result

PubMed Identifier

26744025

Citation

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.

Results Reference

result

PubMed Identifier

28237263

Citation

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.

Results Reference

result

PubMed Identifier

28462892

Citation

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.

Results Reference

result

PubMed Identifier

28386912

Citation

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.

Results Reference

result

PubMed Identifier

28950422

Citation

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.

Results Reference

result

PubMed Identifier

29045079

Citation

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.

Results Reference

result

PubMed Identifier

29145215

Citation

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.

Results Reference

result

PubMed Identifier

35975210

Citation

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.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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

Metabolism and Nutrition Disorder, Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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