Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 957
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Novo Nordisk Investigational Site
    • Merewether, New South Wales, Australia, 2291
      • Novo Nordisk Investigational Site
    • St Leonards, New South Wales, Australia, 2065
      • Novo Nordisk Investigational Site
  • Victoria
    • Heidelberg Heights, Victoria, Australia, 3081
      • Novo Nordisk Investigational Site
    • Melbourne, Victoria, Australia, 3004
      • Novo Nordisk Investigational Site
• Belgium
  • Bruxelles, Belgium, 1200
    • Novo Nordisk Investigational Site
  • Edegem, Belgium, 2650
    • Novo Nordisk Investigational Site
  • Leuven, Belgium, 3000
    • Novo Nordisk Investigational Site
  • Liège, Belgium, 4000
    • Novo Nordisk Investigational Site
  • Mons, Belgium, 7000
    • Novo Nordisk Investigational Site
• Canada
  • Quebec, Canada, G1V 4G2
    • Novo Nordisk Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2V 4J2
      • Novo Nordisk Investigational Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3S 2N6
      • Novo Nordisk Investigational Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Novo Nordisk Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Novo Nordisk Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M4P 1P2
      • Novo Nordisk Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4N 2W2
      • Novo Nordisk Investigational Site
• Germany
  • Dresden, Germany, 01219
    • Novo Nordisk Investigational Site
  • Dresden, Germany, 01307
    • Novo Nordisk Investigational Site
  • Duisburg, Germany, 47051
    • Novo Nordisk Investigational Site
  • Leipzig, Germany, 04103
    • Novo Nordisk Investigational Site
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Novo Nordisk Investigational Site
  • Stuttgart, Germany, 70378
    • Novo Nordisk Investigational Site
  • Wangen, Germany, 88239
    • Novo Nordisk Investigational Site
• Israel
  • Haifa, Israel, 31096
    • Novo Nordisk Investigational Site
  • Jerusalem, Israel, 91120
    • Novo Nordisk Investigational Site
  • Kfar-Saba, Israel, 44281
    • Novo Nordisk Investigational Site
  • Petah-Tikva, Israel, 49100
    • Novo Nordisk Investigational Site
  • Petah-Tikva, Israel, 49372
    • Novo Nordisk Investigational Site
  • Tel Hashomer, Israel, 52621
    • Novo Nordisk Investigational Site
  • Tel-Aviv, Israel, 64239
    • Novo Nordisk Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 117036
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 115478
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 101990
    • Novo Nordisk Investigational Site
  • Moscow, Russian Federation, 109240
    • Novo Nordisk Investigational Site
  • Novosibirsk, Russian Federation, 630047
    • Novo Nordisk Investigational Site
  • Penza, Russian Federation, 440026
    • Novo Nordisk Investigational Site
  • Saint-Petersburg, Russian Federation, 191015
    • Novo Nordisk Investigational Site
  • Tumen, Russian Federation, 625023
    • Novo Nordisk Investigational Site
  • Voronezh, Russian Federation, 394018
    • Novo Nordisk Investigational Site
  • Yaroslavl, Russian Federation, 150003
    • Novo Nordisk Investigational Site
  • Yaroslavl, Russian Federation, 150062
    • Novo Nordisk Investigational Site
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Novo Nordisk Investigational Site
  • Cambridge, United Kingdom, CB2 0QQ
    • Novo Nordisk Investigational Site
  • Glasgow, United Kingdom, G31 2ER
    • Novo Nordisk Investigational Site
  • Liverpool, United Kingdom, L9 7AL
    • Novo Nordisk Investigational Site
  • London, United Kingdom, SE1 9RT
    • Novo Nordisk Investigational Site
  • Luton, United Kingdom, LU4 0DZ
    • Novo Nordisk Investigational Site
  • Norwich, United Kingdom, NR4 7TJ
    • Novo Nordisk Investigational Site
  • Rotherham, United Kingdom, S651DA
    • Novo Nordisk Investigational Site
• United States
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • San Diego, California, United States, 92108
      • Novo Nordisk Investigational Site
  • Colorado
    • Golden, Colorado, United States, 80401
      • Novo Nordisk Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Novo Nordisk Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20011
      • Novo Nordisk Investigational Site
  • Florida
    • Crystal River, Florida, United States, 34429
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32205
      • Novo Nordisk Investigational Site
    • Plantation, Florida, United States, 33324
      • Novo Nordisk Investigational Site
  • Maryland
    • Elkridge, Maryland, United States, 21075-6437
      • Novo Nordisk Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novo Nordisk Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • Novo Nordisk Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novo Nordisk Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Novo Nordisk Investigational Site
    • Greer, South Carolina, United States, 29651
      • Novo Nordisk Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620-7352
      • Novo Nordisk Investigational Site
  • Texas
    • Dallas, Texas, United States, 75251
      • Novo Nordisk Investigational Site
    • Round Rock, Texas, United States, 78681
      • Novo Nordisk Investigational Site
    • Sugar Land, Texas, United States, 77479
      • Novo Nordisk Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Novo Nordisk Investigational Site
    • Richmond, Virginia, United States, 23294
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sema 0.05 mg; Dose 0.05 mg	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Experimental: Sema 0.1 mg; Dose 0.05 or 0.1 mg with dose escalation every fourth week	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Experimental: Sema 0.2 mg; Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Experimental: Sema 0.3 mg; Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Experimental: Sema 0.4 mg; Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Experimental: Sema 0.3 mg (fast dose escalation); Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Experimental: Sema 0.4 mg (fast dose escalation); Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week	Drug: semaglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Active Comparator: Lira 3.0 mg; Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week	Drug: liraglutide; Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
Placebo Comparator: Placebo Sema 0.05 mg; Placebo arm matching active arm Sema 0.05 mg	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Sema 0.1 mg; Placebo arm matching active arm Sema 0.1 mg	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Sema 0.2 mg; Placebo arm matching active arm Sema 0.2 mg	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Sema 0.3 mg; Placebo arm matching active arm Sema 0.3 mg	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Sema 0.4 mg; Placebo arm matching active arm Sema 0.4 mg	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Sema 0.3 mg (fast dose escalation); Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Sema 0.4 mg (fast dose escalation); Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.
Placebo Comparator: Placebo Lira 3.0 mg; Placebo arm matching active arm Lira 3.0 mg	Drug: placebo; Once-daily subcutaneous (s.c., under the skin) administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Change in Body Weight (%)	Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Weight Loss of ≥5% of Baseline Body Weight	Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.	Week 52
Participants With Weight Loss of ≥10% of Baseline Body Weight	Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.	Week 52
Change in Body Weight (kg)	Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in Waist Circumference	Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in Waist to Hip Circumference Ratio	Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in BMI	Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in HbA1c	Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in FPG	Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)	The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.	Week 0, Week 52
Change in SBP	Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in DBP	Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)	Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.	Week 0, Week 52
Change in hsCRP	Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0, Week 52
Change in IWQoL Lite	The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.	Week 0, Week 52
Change in SF-36	Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.	Week 0, Week 52
Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)	Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, Week 52
Compliance With Nutritional Counselling	This outcome measure presents "nutritional compliance results" recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance.	Week 4-52
Number of AEs During the Trial	Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0-59
Number of Hypoglycaemic Episodes During the Trial	Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0-59
Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week	Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 0-59
Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score	This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.	Week 52
Change in ECG	Number of participants with electrocardiogram (ECG) results, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Pulse	Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Haematology: Haemoglobin	Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Haematology: Haematocrit	Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Haematology: Thrombocytes, Leucocytes and Differential Count	Change from baseline (week 0) in haematological parameters, "thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Haematology: Erythrocytes	Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Biochemistry: Creatinine and Bilirubin (Total)	Change from baseline (week 0) in biochemistry parameters, "creatinine and bilirubin (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP	Change from baseline (week 0) in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)	Change from baseline (week 0) in biochemistry parameters, "urea, sodium, potassium and calcium (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Biochemistry: Albumin	Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Biochemistry: Calcitonin	Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Biochemistry: TSH	Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Change in Mental Health Assessed by C-SSRS	Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0 and Week 4-59
Change in Mental Health Assessed by PHQ-9	Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.	Week 0, week 52
Anti-semaglutide Antibodies During and After Treatment	Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.	Week 0-52

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. Epub 2019 Apr 16.
• O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): April 12, 2017

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Nutrition Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN9536-4153; 2014-001540-38 (EudraCT Number); U1111-1155-4660 (Other Identifier: WHO)