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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
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
Official Title: Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity
Estimated Study Start Date : December 8, 2020
Estimated Primary Completion Date : August 26, 2022
Estimated Study Completion Date : October 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Once-weekly injections of gradually increased doses of semaglutide
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

Placebo Comparator: Placebo (semaglutide)
Once-weekly injections of gradually increased doses of semaglutide placebo
Drug: Placebo (semaglutide)
Semaglutide placebo administered s.c. as an adjunct to a reduced-calorie diet and increased physical activity regimen for 44 weeks




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: From baseline at week 0 to week 44 ]
    Percent

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in waist circumference [ Time Frame: From baseline at week 0 to week 44 ]
    cm

  4. Change in systolic blood pressure [ Time Frame: From baseline at week 0 to week 44 ]
    mmHg

  5. 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.

  6. 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.

  7. Change in body weight [ Time Frame: From baseline at week 0 to week 44 ]
    kg

  8. Change in body mass index (BMI) [ Time Frame: From baseline at week 0 to week 44 ]
    kg/m^2

  9. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline at week 0 to week 44 ]
    Percent

  10. Change in HbA1c [ Time Frame: From baseline at week 0 to week 44 ]
    mmol /mol

  11. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  12. Change in fasting serum insulin [ Time Frame: From baseline at week 0 to week 44 ]
    mIU/L

  13. Change in diastolic blood pressure [ Time Frame: From baseline at week 0 to week 44 ]
    mmHg

  14. Change in lipids: Total cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  15. Change in lipids: High density lipoprotein (HDL) cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  16. Change in lipids: Low density lipoprotein (LDL) cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  17. Change in lipids: Very low density lipoprotein (VLDL) cholesterol [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  18. Change in lipids: Free fatty acids (FFA) [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  19. Change in lipids: Triglycerides [ Time Frame: From baseline at week 0 to week 44 ]
    mg/dL

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. Subjects who achieve responder definition value for SF-36 physical functioning score (yes/no) [ Time Frame: Week 44 ]
    Number of subjects

  33. 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

  34. Change in glycaemic category [ Time Frame: From baseline at week 0 to week 44 ]
    Normo-glycaemia, pre-diabetes or T2D

  35. Change in antihypertensive medication [ Time Frame: From baseline at week 0 to week 44 ]
    Decrease, no change, increase

  36. Change in lipid-lowering medication [ Time Frame: From baseline at week 0 to week 44 ]
    Decrease, no change, increase

  37. 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)

  38. 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

  39. Subjects who have permanently discontinued randomised trial product (yes/no) [ Time Frame: From randomisation at week 0 to week 44 ]
    Number of subjects

  40. Time to permanent discontinuation of randomised trial product [ Time Frame: Week 0 - week 44 ]
    Weeks

  41. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From week 0 to week 51 ]
    Count

  42. Number of serious adverse events (SAEs) [ Time Frame: From week 0 to week 51 ]
    Count

  43. 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)

  44. Change in pulse [ Time Frame: From baseline at week 0 to week 44 ]
    Beats per minute (bpm)

  45. Change in amylase [ Time Frame: From baseline at week 0 to week 44 ]
    U/L

  46. Change in lipase [ Time Frame: From baseline at week 0 to week 44 ]
    U/L

  47. Change in calcitonin [ Time Frame: From baseline at week 0 to week 44 ]
    ng/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251156


Locations
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Brazil
Novo Nordisk Investigational Site
Aparecida de Goiania, Goias, Brazil, 74935-530
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 01228-200
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100853
China, Chongqing
Novo Nordisk Investigational Site
ChongQing, Chongqing, China, 404000
China, Fujian
Novo Nordisk Investigational Site
Fuzhou, Fujian, China, 350001
China, Hebei
Novo Nordisk Investigational Site
Cangzhou, Hebei, China, 061000
Novo Nordisk Investigational Site
Hengshui, Hebei, China, 053000
China, Inner Mongolia
Novo Nordisk Investigational Site
Huhehaote, Inner Mongolia, China, 010020
Novo Nordisk Investigational Site
Huhhot, Inner Mongolia, China, 010050
China, Jiangsu
Novo Nordisk Investigational Site
Changzhou, Jiangsu, China, 213003
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210011
Novo Nordisk Investigational Site
Suzhou, Jiangsu, China, 215006
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu, China, 212001
China, Jilin
Novo Nordisk Investigational Site
Changchun, Jilin, China, 130021
China, Shandong
Novo Nordisk Investigational Site
Jinan, Shandong, China, 250013
China, Shanghai
Novo Nordisk Investigational Site
Pudong New District, Shanghai, China, 201200
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200072
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200240
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200336
China, Tianjin
Novo Nordisk Investigational Site
Tianjin, Tianjin, China, 300052
Novo Nordisk Investigational Site
Tianjin, Tianjin, China, 300211
China, Yunnan
Novo Nordisk Investigational Site
Kunming, Yunnan, China, 650101
China
Novo Nordisk Investigational Site
Beijing, China, 101200
Hong Kong
Novo Nordisk Investigational Site
Shatin, New Territories, Hong Kong
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04251156    
Other Study ID Numbers: NN9536-4379
U1111-1212-2189 ( Other Identifier: World Health Organization (WHO) )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Diabetes Mellitus, Type 2
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases