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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03552757
Other study ID # NN9536-4374
Secondary ID U1111-1200-81482
Status Completed
Phase Phase 3
First received
Last updated
Start date June 4, 2018
Est. completion date May 1, 2020

Study information

Verified date November 2021
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years


Recruitment information / eligibility

Status Completed
Enrollment 1210
Est. completion date May 1, 2020
Est. primary completion date March 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female, age greater than or equal to 18 years at the time of signing informed consent - Body Mass Index (BMI) greater than or equal to 27 kg/m^2 ' - History of at least one self-reported unsuccessful dietary effort to lose body weight - Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening Exclusion Criteria: - A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Semaglutide 1.0 mg
Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
Semaglutide 2.4 mg
Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Placebo I (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Placebo II (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Locations

Country Name City State
Argentina Novo Nordisk Investigational Site Caba
Argentina Novo Nordisk Investigational Site Chacabuco
Argentina Novo Nordisk Investigational Site Córdoba
Argentina Novo Nordisk Investigational Site Mendoza
Argentina Novo Nordisk Investigational Site Santiago del Estero
Canada Novo Nordisk Investigational Site Calgary Alberta
Canada Novo Nordisk Investigational Site Concord Ontario
Canada Novo Nordisk Investigational Site London Ontario
Canada Novo Nordisk Investigational Site Montreal Quebec
Canada Novo Nordisk Investigational Site Montreal Quebec
Canada Novo Nordisk Investigational Site Mount Pearl Newfoundland and Labrador
Canada Novo Nordisk Investigational Site St-Marc-des-Carrières Quebec
Canada Novo Nordisk Investigational Site Stoney Creek Ontario
Canada Novo Nordisk Investigational Site Toronto Ontario
Canada Novo Nordisk Investigational Site Toronto Ontario
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Falkensee
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Lingen
Germany Novo Nordisk Investigational Site Münster
Germany Novo Nordisk Investigational Site Rehlingen-Siersburg
Germany Novo Nordisk Investigational Site Schweinfurt
Germany Novo Nordisk Investigational Site Stuttgart
Greece Novo Nordisk Investigational Site Athens
Greece Novo Nordisk Investigational Site Haidari-Athens
Greece Novo Nordisk Investigational Site Thessaloniki
Greece Novo Nordisk Investigational Site Thessaloniki
Greece Novo Nordisk Investigational Site Thessaloniki
Greece Novo Nordisk Investigational Site Thessaloniki
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Ahmedabad Gujarat
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Chennai Tamil Nadu
India Novo Nordisk Investigational Site Coimbatore Tamil Nadu
India Novo Nordisk Investigational Site Jaipur Rajasthan
India Novo Nordisk Investigational Site Kochi Kerala
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site Mumbai Maharashtra
India Novo Nordisk Investigational Site New Dehli New Delhi
India Novo Nordisk Investigational Site New Delhi
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Secunderabad
Japan Novo Nordisk Investigational Site Chiba-shi, Chiba
Japan Novo Nordisk Investigational Site Chuo-ku, Tokyo
Japan Novo Nordisk Investigational Site Fukuoka-shi, Fukuoka
Japan Novo Nordisk Investigational Site Hokkaido
Japan Novo Nordisk Investigational Site Hokkaido
Japan Novo Nordisk Investigational Site Ibaraki
Japan Novo Nordisk Investigational Site Kashiwara-shi, Osaka
Japan Novo Nordisk Investigational Site Mitaka-shi, Tokyo
Japan Novo Nordisk Investigational Site Osaka
Japan Novo Nordisk Investigational Site Osaka
Japan Novo Nordisk Investigational Site Sapporo-shi, Hokkaido
Japan Novo Nordisk Investigational Site Tochigi
Puerto Rico Novo Nordisk Investigational Site San Juan
Russian Federation Novo Nordisk Investigational Site Barnaul
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Russian Federation Novo Nordisk Investigational Site Tomsk
South Africa Novo Nordisk Investigational Site Brits North West
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
Spain Novo Nordisk Investigational Site Almeria
Spain Novo Nordisk Investigational Site Córdoba
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Spain Novo Nordisk Investigational Site San Cristóbal de La Laguna
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Valladolid
United Arab Emirates Novo Nordisk Investigational Site Dubai
United Arab Emirates Novo Nordisk Investigational Site Dubai
United Arab Emirates Novo Nordisk Investigational Site Dubai
United Arab Emirates Novo Nordisk Investigational Site Hatta
United Arab Emirates Novo Nordisk Investigational Site Umm Al Quwain
United Kingdom Novo Nordisk Investigational Site Chester
United Kingdom Novo Nordisk Investigational Site Crewe
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Harrogate, North Yorkshire
United Kingdom Novo Nordisk Investigational Site Leicester
United Kingdom Novo Nordisk Investigational Site Middlesbrough
United Kingdom Novo Nordisk Investigational Site Soham
United Kingdom Novo Nordisk Investigational Site Stevenage
United Kingdom Novo Nordisk Investigational Site Watford
United Kingdom Novo Nordisk Investigational Site Wellingborough
United States Novo Nordisk Investigational Site Alpharetta Georgia
United States Novo Nordisk Investigational Site Anderson South Carolina
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Austin Texas
United States Novo Nordisk Investigational Site Bristol Tennessee
United States Novo Nordisk Investigational Site Buena Park California
United States Novo Nordisk Investigational Site Butte Montana
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Clearwater Florida
United States Novo Nordisk Investigational Site Concord California
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Golden Colorado
United States Novo Nordisk Investigational Site Greensboro North Carolina
United States Novo Nordisk Investigational Site Greenville North Carolina
United States Novo Nordisk Investigational Site Hickory North Carolina
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Kissimmee Florida
United States Novo Nordisk Investigational Site Lawrenceville New Jersey
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Lomita California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Louisville Kentucky
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Mission Hills California
United States Novo Nordisk Investigational Site Mount Pleasant South Carolina
United States Novo Nordisk Investigational Site Nashville Tennessee
United States Novo Nordisk Investigational Site Olive Branch Mississippi
United States Novo Nordisk Investigational Site Olympia Washington
United States Novo Nordisk Investigational Site Roswell Georgia
United States Novo Nordisk Investigational Site Saint George Utah
United States Novo Nordisk Investigational Site Saint Petersburg Florida
United States Novo Nordisk Investigational Site Salisbury North Carolina
United States Novo Nordisk Investigational Site Shavano Park Texas
United States Novo Nordisk Investigational Site Spring Valley California
United States Novo Nordisk Investigational Site Springfield Illinois
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Tarzana California
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Wadsworth Ohio
United States Novo Nordisk Investigational Site West Des Moines Iowa
United States Novo Nordisk Investigational Site Wilmington North Carolina
United States Novo Nordisk Investigational Site Winchester Virginia

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Germany,  Greece,  India,  Japan,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  United Arab Emirates,  United Kingdom, 

References & Publications (2)

Davies M, Færch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a ra — View Citation

Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. Baseline (week 0) to week 68
Primary Participants Who Achieve (Yes/no): Body Weight Reduction =5% - Semaglutide 2.4 mg Versus Placebo Number of participants who achieved weight reduction =5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. At week 68
Secondary Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Participants Who Achieve (Yes/no): Body Weight Reduction =5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg Number of participants who achieved weight reduction =5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Change in Waist Circumference Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Body Weight (Kg) Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in BMI Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Participants Who Achieve (Yes/no): Body Weight Reduction =10% Number of participants who achieved weight reduction =10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Participants Who Achieve (Yes/no): Body Weight Reduction =15% Number of participants who achieved weight reduction =15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Participants Who Achieve (Yes/no): Body Weight Reduction =20% Number of participants who achieved weight reduction =20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Change in HbA1c (%) Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in HbA1c (mmol/Mol) Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in FPG (mg/dL) Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Fasting Serum Insulin Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) Number of participants who achieved HbA1c <7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Participants Who Achieve (Yes/no): HbA1c =6.5% (48 mmol/Mol) Number of participants who achieved HbA1c =6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Participants Who Achieve (Yes/no): Body Weight Reduction =10% and HbA1c <7.0% Number of participants who achieved weight reduction =10% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Participants Who Achieve (Yes/no): Body Weight Reduction =15% and HbA1c <7.0% Number of participants who achieved weight reduction =15% of their baseline body weight and HbA1c <7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. At week 68
Secondary Change in Systolic Blood Pressure Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Diastolic Blood Pressure Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Total Cholesterol Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in HDL Cholesterol Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in LDL Cholesterol Change in low density lipoprotein (LDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in VLDL Cholesterol Change in very low density lipoprotein (VLDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Free Fatty Acids Change in free fatty acids (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Triglycerides Change in triglycerides (measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in hsCRP Change in high sensitivity C-reactive protein (hsCRP; measured in milligram per ilitre (mg/L)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in PAI-1 Activity Change in Plasminogen Activator Inhibitor-1 (PAI-1; measured in arbritary units per millilitre (AU/mL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score) 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™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for 'physical functioning domain'. The 0-100 scale scores 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. Change from week 0 in the domain scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period. Baseline (week 0) to week 68
Secondary Change in SF-36 (All Scores Except Physical Functioning) 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™ questionnaire measured 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains, except physical functioning. The 0-100 scale scores 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. Change from week 0 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. Results are based on the data from in-trial observation period. Baseline (week 0) to week 68
Secondary Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score) The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function domain'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Change in IWQOL-Lite for CT (All Scores Except Physical Function) The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical and psychosocial domains, and for total'. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. Baseline (week 0) to week 68
Secondary Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score The observed number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on two thresholds. The threshold of 4.3 is the default generic responder threshold defined in SF-36 manual for a general population. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. Endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75). At week 68
Secondary Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score The observed number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on two different thresholds. The threshold of 20 was a preliminary responder threshold based on earlier studies. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on the in-trial observation period which was defined as the uninterrupted time interval from randomization (week 0) to last trial related subject-site contact (week 75). At week 68
Secondary Number of TEAEs - Semaglutide 2.4 mg Versus Placebo Adverse events (AEs) with onset during the on-treatment observation period were defined as treatment-emergent AEs (TEAEs). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses. Week 0 to week 75
Secondary Number of SAEs - Semaglutide 2.4 mg Versus Placebo Serious adverse event (SAE) results are based on the on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least seven consecutive missed doses. Week 0 to week 75
Secondary Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least 7 consecutive missed doses. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration. Blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Week 0 to week 75
Secondary Change in Pulse - Semaglutide 2.4 mg Versus Placebo Change in pulse from baseline (week 0) to week 68 is presented. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. Baseline (week 0) to week 68
Secondary Change in Amylase - Semaglutide 2.4 mg Versus Placebo Change in amylase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. Baseline (week 0) to week 68
Secondary Change in Lipase - Semaglutide 2.4 mg Versus Placebo Change in lipase (units/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. Baseline (week 0) to week 68
Secondary Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo Change in calcitonin (nanogram/litre) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses. Baseline (week 0) to week 68
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