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STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity (STEP 6)

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ClinicalTrials.gov Identifier: NCT03811574
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE January 21, 2019
Actual Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Change in body weight (percentage) [ Time Frame: Week 0, Week 68 ]
    Measured in percentage of body weight.
  • Participants with more than or equal to 5% body weight reduction from baseline [ Time Frame: Week 68 ]
    Percentage of participants (yes/no).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Participants with more than or equal to 10% body weight reduction from baseline [ Time Frame: Week 68 ]
    Percentage of participants (yes/no).
  • Participants with more than or equal to 15% body weight reduction from baseline [ Time Frame: Week 68 ]
    Percentage of participants (yes/no).
  • Change in waist circumference (midway between the lower rib margin and the iliac crest) [ Time Frame: Week 0, Week 68 ]
    Measured (in cm) midway between the lower rib margin and the iliac crest.
  • Change in body weight (kg) [ Time Frame: Week 0, Week 68 ]
    Measured in kg.
  • Change in body mass index (BMI) [ Time Frame: Week 0, Week 68 ]
    Measured in kg/m^2.
  • Change in waist circumference (at the navel level) [ Time Frame: Week 0, Week 68 ]
    Measured (in cm) at the navel level, i.e. according to the Japan Society for the Study of Obesity (JASSO) guideline.
  • Change in visceral fat area (VFA) [ Time Frame: Week 0, Week 68 ]
    Measured (in percentage ) by computed tomography (CT) scan in a subset of the Japanese trial population.
  • Change in glycated haemoglobin (HbA1c) [ Time Frame: Week 0, Week 68 ]
    Measured in percentage of HbA1c.
  • 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 μIU/mL.
  • Change in systolic blood pressure [ Time Frame: Week 0, Week 68 ]
    Measured in mmHg.
  • Change in diastolic blood pressure [ Time Frame: Week 0, Week 68 ]
    Measured in mmHg.
  • Change in lipids [ Time Frame: Week 0, Week 68 ]
    Measured in mg/dL. Lipid profile will be included: Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, free fatty acids and triglycerides.
  • 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) [ Time Frame: Week 0, Week 68 ]
    Measured in mg/L.
  • Change in short form-36 (SF-36) [ Time Frame: Week 0, Week 68 ]
    SF-36 measures the subject's overall health related quality of life. It is a 36-item generic measure of health status that yields 2 summary scores for physical health and mental health, and 8 domain scores (role-physical, bodily pain, general health, vitality, physical functioning, social functioning, role-emotional and mental health ). Range of score: 1-100 (1 representing worst results and 100 representing best results).
  • Change in impact of weight on quality of life-lite for clinical trials (IWQoL-Lite for CT) [ Time Frame: Week 0, Week 68 ]
    The IWQoL-Lite for CT is a 20-item modified version of a questionnaire tool designed to assess the weight-related quality of life. Results will be presented for physical function domain (5-items), pain/discomfort domain, psychosocial domain and total score. Range of score: 1-20 (1 representing worst results and 20 representing best results).
  • Participants with definition value for SF-36 physical functioning score [ Time Frame: Week 68 ]
    Percentage of participants (yes/no).
  • Participants with definition value for IWQoL-Lite for CT physical function domain (5-items) [ Time Frame: Week 68 ]
    Percentage of participants (yes/no).
  • Participants with HbA1c less than 7.0% (53 mmol/mol) [ Time Frame: Week 68 ]
    Percentage of participants (yes/no). This endpoint is only for subjects with type 2 diabetes (T2D) at baseline (week 0).
  • Participants with HbA1c less than or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 68 ]
    Percentage of participants (yes/no). This endpoint is only for subjects with T2D at baseline (week 0).
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0-75 ]
    Number of events.
  • Number of serious adverse events (SAEs) [ Time Frame: Weeks 0-75 ]
    Number of events.
  • Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes [ Time Frame: Weeks 0-75 ]
    Number of episodes. This endpoint is only for subjects with T2D at baseline (week 0).
  • 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 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
Official Title  ICMJE Effect and Safety of Semaglutide Once-weekly in East Asian 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. 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, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. 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 one and a half years. Participants will have 14 clinic visits and 11 phone calls 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
  • Overweight
  • Obesity
Intervention  ICMJE
  • Drug: Semaglutide
    Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
  • Drug: Placebo (semaglutide)
    Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
Study Arms  ICMJE
  • Experimental: Semaglutide 2.4 mg
    Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo (semaglutide 2.4 mg)
    Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.
    Intervention: Drug: Placebo (semaglutide)
  • Experimental: Semaglutide 1.7 mg
    Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo (semaglutide 1.7 mg)
    Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.
    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 Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2020)
401
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
400
Actual Study Completion Date  ICMJE November 20, 2020
Actual Primary Completion Date November 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, age more than or equal to 18 years at the time of signing informed consent
  • BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
  • History of at least one self-reported unsuccessful dietary effort to lose body weight
  • For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

Exclusion Criteria:

  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
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 Japan,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811574
Other Study ID Numbers  ICMJE NN9536-4382
U1111-1201-1629 ( Other Identifier: World Health Organization (WHO) )
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: https://www.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 and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2020

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