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STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 1)

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ClinicalTrials.gov Identifier: NCT03548935
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 4, 2020
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 June 4, 2020
Actual Study Start Date  ICMJE June 4, 2018
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Change in body weight [ Time Frame: Week 0, Week 68 ]
    Measured in %.
  • Subjects who achieve 5 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ]
    Number of subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Subjects who achieve 10 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ]
    Number of subjects.
  • Subjects who achieve 15 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ]
    Number of subjects.
  • Change in waist circumference [ Time Frame: Week 0, Week 68 ]
    Measured in cm.
  • Change in systolic blood pressure [ Time Frame: Week 0, Week 68 ]
    Measured in mmHg.
  • Change in physical functioning score (SF-36) [ Time Frame: Week 0, 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 physical function domain (5-item) score (IWQoL-Lite for CT) [ Time Frame: Week 0, Week 68 ]
    The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
  • Change in body weight [ Time Frame: Week 0, Week 68 ]
    Measured in kg.
  • Change in body mass index (BMI) [ Time Frame: Week 0, Week 68 ]
    Measured in kg/m2
  • Change in glycated haemoglobin (HbA1C) [ Time Frame: Week 0, Week 68 ]
    Measured in %.
  • Change in HbA1C [ Time Frame: Week 0, Week 68 ]
    Measured in mmol/mol.
  • Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 68 ]
    Measured in mg/dL.
  • Change in fasting serum insulin [ Time Frame: Week 0, Week 68 ]
    Measured in mIU/L.
  • Change in diastolic blood pressure [ Time Frame: Week 0, Week 68 ]
    Measured in mmHg.
  • Change in lipids (total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, free fatty acids and triglycerides) [ Time Frame: Week 0, Week 68 ]
    Measured in mg/dL.
  • Change in high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, Week 68 ]
    Measured in mg/L.
  • Change in plasminogen activator inhibitor-1 (PAI-1) activity [ Time Frame: Week 0, Week 68 ]
    Measured in AU/mL.
  • Change in soluble leptin receptor [ Time Frame: Week 0, Week 68 ]
    Measured in ng/mL.
  • Change in leptin [ Time Frame: Week 0, Week 68 ]
    Measured in ng/mL.
  • Change in SF-36 (role-physical score) [ Time Frame: Week 0, 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: Week 0, 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: Week 0, 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: Week 0, 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: Week 0, 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: Week 0, 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: Week 0, 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: Week 0, 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: Week 0, 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 IWQoL-Lite for CT (pain/discomfort domain score) [ Time Frame: Week 0, Week 68 ]
    The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
  • Change in IWQoL-Lite for CT (psychosocial domain score) [ Time Frame: Week 0, Week 68 ]
    The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
  • Change in IWQoL-Lite for CT (total score) [ Time Frame: Week 0, Week 68 ]
    The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.
  • Change in body composition (total fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by dual energy X-ray absorpmetry (DEXA). Measured in %.
  • Change in body composition (total fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in g.
  • Change in body composition (lean body mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in %.
  • Change in body composition (lean body mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in g.
  • Change in body composition (visceral fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in %.
  • Change in body composition (visceral fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in g.
  • Subjects who achieve "responder definition value" (yes/no) for SF-36 physical functioning score [ Time Frame: Week 68 ]
    Number of subjects.
  • Subjects who achieve "responder definition value" (yes/no) for IWQoL-Lite for CT physical function domain (5-items) score [ Time Frame: Week 68 ]
    Number of subjects.
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0 to 75 ]
    Number of events.
  • Number of serious adverse events (SAEs) [ Time Frame: Weeks 0 to 75 ]
    Number of events.
  • Change in pulse [ Time Frame: Week 0, Week 68 ]
    Measured in bpm.
  • Change in amylase [ Time Frame: Week 0, Week 68 ]
    Measured in U/L.
  • Change in lipase [ Time Frame: Week 0, Week 68 ]
    Measured in U/L.
  • Change in calcitonin [ Time Frame: Week 0, Week 68 ]
    Measured in ng/L.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STEP 1: 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
Brief Summary This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.
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
  • Overweight or Obesity
Intervention  ICMJE
  • Drug: Semaglutide
    Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.
  • Drug: Placebo (semaglutide)
    Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.
Study Arms  ICMJE
  • Experimental: Semaglutide s.c. 2.4 mg once weekly
    Participants will receive semaglutide for 68 weeks.
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Semaglutide placebo
    Participants will receive semaglutide matching placebo for 68 weeks.
    Intervention: Drug: Placebo (semaglutide)
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: April 23, 2020)
1964
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
1950
Actual Study Completion Date  ICMJE April 19, 2020
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Main phase:

  • 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 30.0 kg/sqm or greater than or equal to 27.0 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

Extension phase:

  • Informed consent for the extension phase obtained before any trial related activities for the extension phase
  • On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo

Exclusion Criteria:

Main phase:

  • Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Extension phase:

  • Female who is pregnant or intends to become pregnant during the extension phase
  • Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
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 Argentina,   Belgium,   Bulgaria,   Canada,   Denmark,   Finland,   France,   Germany,   India,   Japan,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548935
Other Study ID Numbers  ICMJE NN9536-4373
U1111-1200-8053 ( Other Identifier: World Health Organization (WHO) )
2017-003436-36 ( 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 June 2020

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