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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02453711




Registration number
NCT02453711
Ethics application status
Date submitted
21/05/2015
Date registered
25/05/2015
Date last updated
17/04/2020

Titles & IDs
Public title
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Scientific title
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Secondary ID [1] 0 0
2014-001540-38
Secondary ID [2] 0 0
NN9536-4153
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolism and Nutrition Disorder 0 0
Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - semaglutide
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo

Experimental: Sema 0.05 mg - Dose 0.05 mg

Experimental: Sema 0.1 mg - Dose 0.05 or 0.1 mg with dose escalation every fourth week

Experimental: Sema 0.2 mg - Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week

Experimental: Sema 0.3 mg - Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week

Experimental: Sema 0.4 mg - Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week

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

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

Active comparator: Lira 3.0 mg - Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week

Placebo comparator: Placebo Sema 0.05 mg - Placebo arm matching active arm Sema 0.05 mg

Placebo comparator: Placebo Sema 0.1 mg - Placebo arm matching active arm Sema 0.1 mg

Placebo comparator: Placebo Sema 0.2 mg - Placebo arm matching active arm Sema 0.2 mg

Placebo comparator: Placebo Sema 0.3 mg - Placebo arm matching active arm Sema 0.3 mg

Placebo comparator: Placebo Sema 0.4 mg - Placebo arm matching active arm Sema 0.4 mg

Placebo comparator: Placebo Sema 0.3 mg (fast dose escalation) - Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)

Placebo comparator: Placebo Sema 0.4 mg (fast dose escalation) - Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)

Placebo comparator: Placebo Lira 3.0 mg - Placebo arm matching active arm Lira 3.0 mg


Treatment: Drugs: semaglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Treatment: Drugs: liraglutide
Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Treatment: Drugs: placebo
Once-daily subcutaneous (s.c., under the skin) administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative Change in Body Weight (%)
Timepoint [1] 0 0
Week 0, Week 52
Secondary outcome [1] 0 0
Participants With Weight Loss of =5% of Baseline Body Weight
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Participants With Weight Loss of =10% of Baseline Body Weight
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Change in Body Weight (kg)
Timepoint [3] 0 0
Week 0, Week 52
Secondary outcome [4] 0 0
Change in Waist Circumference
Timepoint [4] 0 0
Week 0, Week 52
Secondary outcome [5] 0 0
Change in Waist to Hip Circumference Ratio
Timepoint [5] 0 0
Week 0, Week 52
Secondary outcome [6] 0 0
Change in BMI
Timepoint [6] 0 0
Week 0, Week 52
Secondary outcome [7] 0 0
Change in HbA1c
Timepoint [7] 0 0
Week 0, Week 52
Secondary outcome [8] 0 0
Change in FPG
Timepoint [8] 0 0
Week 0, Week 52
Secondary outcome [9] 0 0
Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)
Timepoint [9] 0 0
Week 0, Week 52
Secondary outcome [10] 0 0
Change in SBP
Timepoint [10] 0 0
Week 0, Week 52
Secondary outcome [11] 0 0
Change in DBP
Timepoint [11] 0 0
Week 0, Week 52
Secondary outcome [12] 0 0
Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)
Timepoint [12] 0 0
Week 0, Week 52
Secondary outcome [13] 0 0
Change in hsCRP
Timepoint [13] 0 0
Week 0, Week 52
Secondary outcome [14] 0 0
Change in IWQoL Lite
Timepoint [14] 0 0
Week 0, Week 52
Secondary outcome [15] 0 0
Change in SF-36
Timepoint [15] 0 0
Week 0, Week 52
Secondary outcome [16] 0 0
Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)
Timepoint [16] 0 0
Week 0, Week 52
Secondary outcome [17] 0 0
Compliance With Nutritional Counselling
Timepoint [17] 0 0
Week 4-52
Secondary outcome [18] 0 0
Number of AEs During the Trial
Timepoint [18] 0 0
Week 0-59
Secondary outcome [19] 0 0
Number of Hypoglycaemic Episodes During the Trial
Timepoint [19] 0 0
Week 0-59
Secondary outcome [20] 0 0
Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week
Timepoint [20] 0 0
Week 0-59
Secondary outcome [21] 0 0
Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score
Timepoint [21] 0 0
Week 52
Secondary outcome [22] 0 0
Change in ECG
Timepoint [22] 0 0
Week 0, week 52
Secondary outcome [23] 0 0
Change in Pulse
Timepoint [23] 0 0
Week 0, week 52
Secondary outcome [24] 0 0
Change in Haematology: Haemoglobin
Timepoint [24] 0 0
Week 0, week 52
Secondary outcome [25] 0 0
Change in Haematology: Haematocrit
Timepoint [25] 0 0
Week 0, week 52
Secondary outcome [26] 0 0
Change in Haematology: Thrombocytes, Leucocytes and Differential Count
Timepoint [26] 0 0
Week 0, week 52
Secondary outcome [27] 0 0
Change in Haematology: Erythrocytes
Timepoint [27] 0 0
Week 0, week 52
Secondary outcome [28] 0 0
Change in Biochemistry: Creatinine and Bilirubin (Total)
Timepoint [28] 0 0
Week 0, week 52
Secondary outcome [29] 0 0
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Timepoint [29] 0 0
Week 0, week 52
Secondary outcome [30] 0 0
Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)
Timepoint [30] 0 0
Week 0, week 52
Secondary outcome [31] 0 0
Change in Biochemistry: Albumin
Timepoint [31] 0 0
Week 0, week 52
Secondary outcome [32] 0 0
Change in Biochemistry: Calcitonin
Timepoint [32] 0 0
Week 0, week 52
Secondary outcome [33] 0 0
Change in Biochemistry: TSH
Timepoint [33] 0 0
Week 0, week 52
Secondary outcome [34] 0 0
Change in Mental Health Assessed by C-SSRS
Timepoint [34] 0 0
Week 0 and Week 4-59
Secondary outcome [35] 0 0
Change in Mental Health Assessed by PHQ-9
Timepoint [35] 0 0
Week 0, week 52
Secondary outcome [36] 0 0
Anti-semaglutide Antibodies During and After Treatment
Timepoint [36] 0 0
Week 0-52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2017
Sample size
Target
Accrual to date
Final
957
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Merewether
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Heidelberg Heights
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
Belgium
State/province [17] 0 0
Liège
Country [18] 0 0
Belgium
State/province [18] 0 0
Mons
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
New Brunswick
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Germany
State/province [25] 0 0
Dresden
Country [26] 0 0
Germany
State/province [26] 0 0
Duisburg
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Germany
State/province [28] 0 0
Saint Ingbert-Oberwürzbach
Country [29] 0 0
Germany
State/province [29] 0 0
Stuttgart
Country [30] 0 0
Germany
State/province [30] 0 0
Wangen
Country [31] 0 0
Israel
State/province [31] 0 0
Haifa
Country [32] 0 0
Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Israel
State/province [33] 0 0
Kfar-Saba
Country [34] 0 0
Israel
State/province [34] 0 0
Petah-Tikva
Country [35] 0 0
Israel
State/province [35] 0 0
Tel Hashomer
Country [36] 0 0
Israel
State/province [36] 0 0
Tel-Aviv
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Novosibirsk
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Penza
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Saint-Petersburg
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Tumen
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Voronezh
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Yaroslavl
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Bristol
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Cambridge
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Glasgow
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Liverpool
Country [48] 0 0
United Kingdom
State/province [48] 0 0
London
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Luton
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Norwich
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Rotherham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02453711
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02453711