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Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity (STEP 7)

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ClinicalTrials.gov Identifier: NCT04251156
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date November 27, 2020
Estimated Study Start Date  ICMJE December 8, 2020
Estimated Primary Completion Date August 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Change in body weight [ Time Frame: From baseline at week 0 to week 44 ]
    Percent
  • Subjects who achieve body weight reduction equal to or above 5% (yes/no) [ Time Frame: From baseline at week 0 to week 44 ]
    Number of subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Subjects who achieve body weight reduction equal to or above 10% (yes/no) [ Time Frame: From baseline at week 0 to week 44 ]
    Number of subjects
  • Subjects who achieve body weight reduction equal to or above 15% (yes/no) [ Time Frame: From baseline at week 0 to week 44 ]
    Number of subjects
  • Change in waist circumference [ Time Frame: From baseline at week 0 to week 44 ]
    cm
  • Change in systolic blood pressure [ Time Frame: From baseline at week 0 to week 44 ]
    mmHg
  • Change in physical functioning score [ Time Frame: From baseline at week 0 to week 44 ]
    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-items) score [ Time Frame: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    kg
  • Change in body mass index (BMI) [ Time Frame: From baseline at week 0 to week 44 ]
    kg/m^2
  • Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline at week 0 to week 44 ]
    Percent
  • Change in HbA1c [ Time Frame: From baseline at week 0 to week 44 ]
    mmol /mol
  • Change in fasting plasma glucose (FPG) [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in fasting serum insulin [ Time Frame: From baseline at week 0 to week 44 ]
    mIU/L
  • Change in diastolic blood pressure [ Time Frame: From baseline at week 0 to week 44 ]
    mmHg
  • Change in lipids: Total cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in lipids: High density lipoprotein (HDL) cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in lipids: Low density lipoprotein (LDL) cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in lipids: Very low density lipoprotein (VLDL) cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in lipids: Free fatty acids (FFA) [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in lipids: Triglycerides [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL
  • Change in SF-36: role-physical score [ Time Frame: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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: From baseline at week 0 to week 44 ]
    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.
  • Subjects who achieve responder definition value for SF-36 physical functioning score (yes/no) [ Time Frame: Week 44 ]
    Number of subjects
  • Subjects who achieve responder definition value for IWQoL-Lite for CT physical function domain (5-items) score (yes/no) [ Time Frame: Week 44 ]
    Number of subjects
  • Change in glycaemic category [ Time Frame: From baseline at week 0 to week 44 ]
    Normo-glycaemia, pre-diabetes or T2D
  • Change in antihypertensive medication [ Time Frame: From baseline at week 0 to week 44 ]
    Decrease, no change, increase
  • Change in lipid-lowering medication [ Time Frame: From baseline at week 0 to week 44 ]
    Decrease, no change, increase
  • Change in concomitant oral antidiabetic medication [ Time Frame: From baseline at week 0 to week 44 ]
    Decrease, no change, increase (only applies to subjects with T2D at week 0)
  • Change in fatty liver index (FLI) score category [ Time Frame: From baseline at week 0 to week 44 ]
    Below 30, equal to or above 30 and below 60, equal to or above 60
  • Subjects who have permanently discontinued randomised trial product (yes/no) [ Time Frame: From randomisation at week 0 to week 44 ]
    Number of subjects
  • Time to permanent discontinuation of randomised trial product [ Time Frame: Week 0 - week 44 ]
    Weeks
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: From week 0 to week 51 ]
    Count
  • Number of serious adverse events (SAEs) [ Time Frame: From week 0 to week 51 ]
    Count
  • Number of treatment emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes (yes/no) [ Time Frame: From week 0 to week 51 ]
    Count (only applies to subjects with T2D at week 0)
  • Change in pulse [ Time Frame: From baseline at week 0 to week 44 ]
    Beats per minute (bpm)
  • Change in amylase [ Time Frame: From baseline at week 0 to week 44 ]
    U/L
  • Change in lipase [ Time Frame: From baseline at week 0 to week 44 ]
    U/L
  • Change in calcitonin [ Time Frame: From baseline at week 0 to week 44 ]
    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 Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity
Official Title  ICMJE Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity
Brief Summary This study will look at the change in body weight from the start to the end of the study. The purpose of the study 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 participants will have talks with study staff about healthy food choices, how to be more physically active and what else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment 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 skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
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
  • Overweight
  • Obesity
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Semaglutide
    Semaglutide administered subcutaneously (s.c., under the skin) as well as diet and physical activity counselling for 44 weeks. Doses gradually increased to 2.4 mg
  • Drug: Placebo (semaglutide)
    Semaglutide placebo administered s.c. as an adjunct to a reduced-calorie diet and increased physical activity regimen for 44 weeks
Study Arms  ICMJE
  • Experimental: Semaglutide
    Once-weekly injections of gradually increased doses of semaglutide
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo (semaglutide)
    Once-weekly injections of gradually increased doses of semaglutide placebo
    Intervention: Drug: Placebo (semaglutide)
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
375
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 12, 2022
Estimated Primary Completion Date August 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age 18 years or older at the time of signing informed consent
  • Body mass index (BMI) equal to or above 30 kg/m^2, or equal to or above 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease, or BMI equal to or above 27 kg/m^2 with T2D
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

For subjects with T2D at screening:

  • Diagnosed with T2D at least 180 days prior to the day of screening
  • Treated with either: diet and exercise alone or stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label
  • HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

Exclusion Criteria:

  • A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

For subjects without T2D at screening:

- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening

For subjects with T2D at screening:

  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m^2 (below 60 mL/min/1.73 m^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil,   China,   Hong Kong,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251156
Other Study ID Numbers  ICMJE NN9536-4379
U1111-1212-2189 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2020

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