Clinical trial NCT02453711: Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Official title: Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 957
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Relative Change in Body Weight (%)
timeFrame: Week 0, Week 52
Secondary outcomes:
measure: Participants With Weight Loss of ≥5% of Baseline Body Weight
timeFrame: Week 52
measure: Participants With Weight Loss of ≥10% of Baseline Body Weight
timeFrame: Week 52
measure: Change in Body Weight (kg)
timeFrame: Week 0, Week 52
measure: Change in Waist Circumference
timeFrame: Week 0, Week 52
measure: Change in Waist to Hip Circumference Ratio
timeFrame: Week 0, Week 52
measure: Change in BMI
timeFrame: Week 0, Week 52
measure: Change in HbA1c
timeFrame: Week 0, Week 52
measure: Change in FPG
timeFrame: Week 0, Week 52
measure: Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)
timeFrame: Week 0, Week 52
measure: Change in SBP
timeFrame: Week 0, Week 52
measure: Change in DBP
timeFrame: Week 0, Week 52
measure: Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)
timeFrame: Week 0, Week 52
measure: Change in hsCRP
timeFrame: Week 0, Week 52
measure: Change in IWQoL Lite
timeFrame: Week 0, Week 52
measure: Change in SF-36
timeFrame: Week 0, Week 52
measure: Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)
timeFrame: Week 0, Week 52
measure: Compliance With Nutritional Counselling
timeFrame: Week 4-52
measure: Number of AEs During the Trial
timeFrame: Week 0-59
measure: Number of Hypoglycaemic Episodes During the Trial
timeFrame: Week 0-59
measure: Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week
timeFrame: Week 0-59
measure: Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score
timeFrame: Week 52
measure: Change in ECG
timeFrame: Week 0, week 52
measure: Change in Pulse
timeFrame: Week 0, week 52
measure: Change in Haematology: Haemoglobin
timeFrame: Week 0, week 52
measure: Change in Haematology: Haematocrit
timeFrame: Week 0, week 52
measure: Change in Haematology: Thrombocytes, Leucocytes and Differential Count
timeFrame: Week 0, week 52
measure: Change in Haematology: Erythrocytes
timeFrame: Week 0, week 52
measure: Change in Biochemistry: Creatinine and Bilirubin (Total)
timeFrame: Week 0, week 52
measure: Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
timeFrame: Week 0, week 52
measure: Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)
timeFrame: Week 0, week 52
measure: Change in Biochemistry: Albumin
timeFrame: Week 0, week 52
measure: Change in Biochemistry: Calcitonin
timeFrame: Week 0, week 52
measure: Change in Biochemistry: TSH
timeFrame: Week 0, week 52
measure: Change in Mental Health Assessed by C-SSRS
timeFrame: Week 0 and Week 4-59
measure: Change in Mental Health Assessed by PHQ-9
timeFrame: Week 0, week 52
measure: Anti-semaglutide Antibodies During and After Treatment
timeFrame: Week 0-52
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Golden
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Novo Nordisk Investigational Site
state: District of Columbia
city: Crystal River
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Elkridge
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Rochester
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Merewether
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Heidelberg Heights
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edegem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Liège
country: Belgium
facility: Novo Nordisk Investigational Site
city: Mons
country: Belgium
facility: Novo Nordisk Investigational Site
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: Novo Nordisk Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: Novo Nordisk Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Wangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Kfar-Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel-Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Penza
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tumen
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Voronezh
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Luton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norwich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Rotherham
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.