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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03548987
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : September 11, 2019
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
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE June 4, 2018
Estimated Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Current 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 %
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03548987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • 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 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
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 * 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.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
902
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
1060
Estimated Study Completion Date  ICMJE March 20, 2020
Estimated Primary Completion Date February 3, 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 September 2019

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