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Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 4)

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ClinicalTrials.gov Identifier: NCT03548987
Recruitment Status : Completed
First Posted : June 7, 2018
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 7, 2018
Results First Submitted Date  ICMJE February 19, 2021
Results First Posted Date  ICMJE March 15, 2021
Last Update Posted Date March 15, 2021
Actual Study Start Date  ICMJE June 4, 2018
Actual Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2021)
Change From Randomisation to Week 68 in Body Weight (%) [ Time Frame: Randomisation (week 20) to week 68 ]
Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Change From Randomisation to Week 68 in Body Weight (%) [ Time Frame: Randomization (week 20), week 68 ]
Measured in %
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2021)
  • Change in Waist Circumference [ Time Frame: Randomization (week 20) to week 68 ]
    Change in waist circumference from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Systolic Blood Pressure [ Time Frame: Randomization (week 20) to week 68 ]
    Change in systolic blood pressure from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Diastolic Blood Pressure [ Time Frame: Randomization (week 20) to week 68 ]
    Change in diastolic blood pressure from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Physical Functioning Score (Short Form 36 [SF-36]) [ Time Frame: Randomization (week 20) to week 68 ]
    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 eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). 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 20 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Body Weight [Kilogram (Kg)] [ Time Frame: Randomisation (week 20) to week 68 ]
    Change in body weight from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Body Mass Index (BMI) [ Time Frame: Randomization (week 20) to week 68 ]
    Change in BMI from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Haemoglobin A1c (HbA1c) [%] [ Time Frame: Randomization (week 20) to week 68 ]
    Change in HbA1c from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in HbA1c [Millimoles Per Mole (mmol/Mol)] [ Time Frame: Randomization (week 20) to week 68 ]
    Change in HbA1c from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)] [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting plasma glucose from week 20 to week 68 is presented.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)] [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting plasma glucose from week 20 to week 68 is presented.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Fasting Serum Insulin [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting serum insulin from baseline (week 20) to week 68 [measured as milli-international units per milliliter (mIU/mL)] is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Total Cholesterol [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting total cholesterol from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in High-density Lipoproteins (HDL) [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting HDL from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Low-density Lipoproteins (LDL) [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting LDL from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Very Low-density Lipoproteins (VLDL) [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting VLDL from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Free Fatty Acids [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting free fatty acids from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Triglycerides [ Time Frame: Randomization (week 20) to week 68 ]
    Change in fasting triglycerides from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score [ Time Frame: Randomisation (week 20) to week 68 ]
    The number of participants achieving at least a 4.3-point increase in SF-36 physical functioning score from baseline (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved 4.3 points of increase of the score and 'No' infers number of participants who have not achieved 4.3 points of increase of the score. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Subjects Who Gain Weight (Yes/no) [ Time Frame: Randomisation (week 20) to week 68 ]
    The number of participants with weight gain from the start of the randomised period (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have gained weight and 'No' infers number of participants who have not gained weight. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Change in Body Weight [ Time Frame: Run-in (week 0) to week 68 ]
    The body weight change (%) from week 0 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Subjects Who Achieve (Yes/no): Body Weight Reduction < 0% [ Time Frame: Run-in (week 0) to week 68 ]
    The number of participants who achieved less than (<) 0% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved <0% weight loss whereas 'No' infers number of participants who have not achieved <0% weight loss.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5% [ Time Frame: Run-in (week 0) to week 68 ]
    The number of participants who achieved greater than or equal to (≥) 5% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 5% weight loss whereas 'No' infers number of participants who have not achieved ≥ 5% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10% [ Time Frame: Run-in (week 0) to week 68 ]
    The number of participants who achieved ≥ 10% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15% [ Time Frame: Run-in (week 0) to week 68 ]
    The number of participants who achieved ≥ 15% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
  • Number of Treatment-emergent Adverse Events (AEs) [ Time Frame: Run-in (week 0) to randomisation (week 20) ]
    An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 0-20 run-in period). The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
  • Number of Treatment-emergent AEs [ Time Frame: Randomisation (week 20) to week 75 ]
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 20-75). The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Run-in (week 0) to randomisation (week 20) ]
    A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred during run-in period from week 0 to week 20 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
  • Number of Serious Adverse Events (SAEs) [ Time Frame: Randomisation (week 20) to week 75 ]
    A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred during run-in period from week 0 to week 20 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
  • Change in Pulse [ Time Frame: Run-in (week 0) to randomisation (week 20) ]
    Change in pulse rate from week 0 week to week 20 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Pulse [ Time Frame: Randomisation (week 20) to week 68 ]
    Change in pulse from week 20 and 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period.On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Amylase [ Time Frame: Run-in (week) 0 to randomization (week 20) ]
    Change in amylase (measured as units per liter [U/L]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Amylase [ Time Frame: Randomisation (week 20) to week 68 ]
    Change in amylase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Lipase [ Time Frame: Run-in (week 0) to randomization (week 20) ]
    Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Lipase [ Time Frame: Randomisation (week 20) to week 68 ]
    Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Calcitonin [ Time Frame: Run-in (week 0) to randomization (week 20) ]
    Change in calcitonin (measured as nanogram per liter (ng/L)]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
  • Change in Calcitonin [ Time Frame: Randomisation (week 20) to week 68 ]
    Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Change in Waist Circumference [ Time Frame: Randomization (week 20), week 68 ]
    Measured in cm
  • Change in Systolic Blood Pressure [ Time Frame: Randomization (week 20), week 68 ]
    Measured in mmHg
  • Change in physical functioning score (Short Form 36 [SF-36]) [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
  • Change in Total score (Weight Related Sign and Symptom Measure[WRSSM]) [ Time Frame: Randomization (week 20), week 68 ]
    The WRSSM measures the presence and bothersomeness of 10 weight-related symptoms. The tool assesses the multifaceted aspects of obesity on symptom experience.
  • Change in body weight [ Time Frame: Randomisation (week 20), week 68 ]
    Measured in kg
  • Change in Body Mass Index (BMI) [ Time Frame: Randomization (week 20), week 68 ]
    Measured in kg/sqm
  • Change in haemoglobin A1c (HbA1c) [ Time Frame: Randomization (week 20), week 68 ]
    measured in %
  • Change in HbA1c [ Time Frame: Randomization (week 20), week 68 ]
    measured in mmol/mol
  • Change in fasting plasma glucose [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in fasting serum insulin [ Time Frame: Randomization (week 20), week 68 ]
    measured in mIU/L
  • Change in Diastolic Blood Pressure [ Time Frame: Randomization (week 20), week 68 ]
    measured in mmHg
  • Change in Total Cholesterol [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in High-density Lipoproteins (HDL) [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in Low-density Lipoproteins (LDL) [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in Very Low-density Lipoproteins (VLDL) [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in Free Fatty Acids [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in Triglycerides [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL
  • Change in SF-36 role-physical score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
  • Change in SF-36 bodily pain score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
  • Change in SF-36 general health score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 vitality score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 social functioning score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 role-emotional score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 mental health score [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health
  • Change in SF-36 physical component summary [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
  • Change in SF-36 mental component summary [ Time Frame: Randomization (week 20), week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
  • Subjects who achieve (yes/no): Responder definition value for SF-36 physical functioning score [ Time Frame: From randomisation (week 20) to week 68 ]
    Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.
  • Subjects who achieve (yes/no): Responder definition value for WRSSM total score [ Time Frame: From randomisation (week 20) to week 68 ]
    The WRSSM measures the presence and bothersomeness of 10 weight-related symptoms. The tool assesses the multifaceted aspects of obesity on symptom experience.
  • Subjects Who Gain Weight (Yes/no) [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subject
  • Change in Body Weight [ Time Frame: week 0, week 68 ]
    Measured in %
  • Subjects who achieve (yes/no): Body weight reduction < 0% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): Body weight reduction ≥ 5% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects
  • Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects
  • Subjects who achieve (yes/no): Body weight reduction ≥ 15% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects
  • Number of treatment-emergent adverse events (AEs) [ Time Frame: From week 0 to randomisation (week 20) ]
    count of events
  • Number of serious adverse events (SAEs) [ Time Frame: From week 0 to randomisation (week 20) ]
    count of events
  • Change in pulse [ Time Frame: week 0, randomisation (week 20) ]
    Measured in beats per minutes
  • Change in amylase [ Time Frame: week 0, randomization (week 20) ]
    measured in U/L
  • Change in lipase [ Time Frame: week 0, randomization (week 20) ]
    measured in U/L
  • Change in calcitonin [ Time Frame: week 0, randomization (week 20) ]
    measured in ng/L
  • Number of treatment-emergent AEs [ Time Frame: From randomisation (week 20) to week 75 ]
    count of events
  • Number of Number of SAEs [ Time Frame: From randomisation (week 20) to week 75 ]
    count of events
  • Change in pulse [ Time Frame: From randomisation (week 20) to week 75 ]
    Measured in beats per minutes
  • Change in amylase [ Time Frame: From randomisation (week 20) to week 75 ]
    measured in U/L
  • Change in lipase [ Time Frame: From randomisation (week 20) to week 75 ]
    measured in U/L
  • Change in calcitonin [ Time Frame: From randomisation (week 20) to week 75 ]
    measured in ng/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Official Title  ICMJE Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period
Brief Summary

This study will look at the change in 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 medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolism and Nutrition Disorder
  • Obesity
Intervention  ICMJE
  • Drug: Semaglutide
    Subcutaneous (under the skin) injection of semaglutide once-weekly.
  • Drug: Placebo
    Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.
Study Arms  ICMJE
  • Experimental: Semaglutide

    Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.

    Maintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68).

    The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo

    Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.

    Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68).

    The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

    Interventions:
    • Drug: Semaglutide
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
902
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
1060
Actual Study Completion Date  ICMJE March 20, 2020
Actual Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm with the presence of at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

  • Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening
  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Israel,   Netherlands,   Portugal,   South Africa,   Spain,   Sweden,   Switzerland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548987
Other Study ID Numbers  ICMJE NN9536-4376
U1111-1201-0898 ( Other Identifier: World Health Organization (WHO) )
2017-003473-34 ( Registry Identifier: European Medicines Agency (EudraCT) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com/sharing-results
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP