Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity (STEP 2)

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: NCT03552757
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study will look at the change in the 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 study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time 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

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: Semaglutide 1.0 mg Drug: Semaglutide 2.4 mg Drug: Placebo I (Semaglutide) Drug: Placebo II (Semaglutide) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : March 16, 2020
Estimated Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide 1.0 mg
Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Semaglutide 1.0 mg
Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Drug: Placebo I (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Experimental: Semaglutide 2.4 mg
Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Semaglutide 2.4 mg
Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Drug: Placebo II (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Placebo Comparator: Semaglutide placebo I/II
Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Placebo I (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Drug: Placebo II (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Week 0, week 68 ]
    Measured in %

  2. Subjects who achieve (yes/no): Body weight reduction greater than or equal to 5% [ Time Frame: Week 0, week 68 ]
    Number of subjects


Secondary Outcome Measures :
  1. Subjects who achieve (yes/no): Body weight reduction greater than or equal to 10% [ Time Frame: Week 0, week 68 ]
    Number of subjects

  2. Subjects who achieve (yes/no): Body weight reduction greater than or equal to 15% [ Time Frame: Week 0, week 68 ]
    Number of subjects

  3. Change in waist circumference [ Time Frame: Week 0, week 68 ]
    Measured in centimetre

  4. Change in body weight (%) (semaglutide s.c. 2.4 mg once-weekly versus semaglutide s.c. 1.0 mg once-weekly) [ Time Frame: Week 0, week 68 ]
    Measured in %

  5. Change in haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 68 ]
    Measured in %

  6. Change in HbA1c [ Time Frame: Week 0, week 68 ]
    Measured in mmol/mol

  7. Change in systolic blood pressure [ Time Frame: Week 0, week 68 ]
    Measured in mmHg

  8. Change in physical functioning score (short form-36 [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

  9. Change in physical function domain (5-items) score (Impact of weight on quality of Life-lite [IWQoL-Lite] for Clinical Trials [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.

  10. Change in body weight [ Time Frame: Week 0, week 68 ]
    Measured in kg

  11. Change in body mass index (BMI) [ Time Frame: Week 0, week 68 ]
    Measured in kg/m^2

  12. Change in HbA1c (semaglutide s.c. 1.0 mg once-weekly versus semaglutide placebo I/II) [ Time Frame: Week 0, week 68 ]
    Measured in %

  13. Change in HbA1c (semaglutide s.c. 1.0 mg once-weekly versus semaglutide placebo I/II) [ Time Frame: Week 0, week 68 ]
    Measured in mmol/mol

  14. Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  15. Change in fasting serum insulin [ Time Frame: Week 0, week 68 ]
    Measured in mIU/L

  16. Change in diastolic blood pressure [ Time Frame: Week 0, week 68 ]
    Measured in mmHg

  17. Change in total cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  18. Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  19. Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  20. Change in very low density lipoprotein (VLDL) cholesterol [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  21. Change in free fatty acids [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  22. Change in triglycerides [ Time Frame: Week 0, week 68 ]
    Measured in mg/dL

  23. Change in high sensitivity C-Reactive Protein [ Time Frame: Week 0, week 68 ]
    Measured in mg/L

  24. Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity [ Time Frame: Week 0, week 68 ]
    Measured in AU/mL

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. Change in IWQoL-Lite for CT (pain/discomfort domain score) [ 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.

  35. Change in IWQoL-Lite for CT (psychosocial domain score) [ 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.

  36. Change in IWQoL-Lite for CT (total score) [ 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.

  37. Subjects who achieve (yes/no): Responder definition value for SF-36 physical functioning score [ Time Frame: week 0, week 68 ]
    Number of subjects

  38. Subjects who achieve (yes/no): Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score [ Time Frame: Week 0, week 68 ]
    Number of subjects

  39. Subjects who achieve (yes/no): HbA1c less than 7.0% (53 mmol/mol) [ Time Frame: Week 0, week 68 ]
    Number of subjects

  40. Subjects who achieve (yes/no): HbA1c less than or equal to 6.5% (48 mmol/mol) [ Time Frame: Week 0, week 68 ]
    Number of subjects

  41. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: From week 0 to week 75 ]
    Number of events

  42. Number of serious adverse events (SAEs) [ Time Frame: From week 0 to week 75 ]
    Number of events

  43. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes [ Time Frame: From week 0 to week 75 ]
    Number of events

  44. Change in pulse [ Time Frame: Week 0, week 68 ]
    measured in beats per minute

  45. Change in amylase [ Time Frame: Week 0, week 68 ]
    measured in U/L

  46. Change in lipase [ Time Frame: Week 0, week 68 ]
    measured in U/L

  47. Change in calcitonin [ Time Frame: Week 0, week 68 ]
    measured in 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.


Layout table for eligibility information
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 greater than or equal to 18 years at the time of signing informed consent
  • Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '
  • History of at least one self-reported unsuccessful dietary effort to lose body weight
  • Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • 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 Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

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): NCT03552757


  Hide Study Locations
Locations
Layout table for location information
United States, California
Novo Nordisk Investigational Site
Concord, California, United States, 94520
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Hawaiian Gardens, California, United States, 90716
Novo Nordisk Investigational Site
Lomita, California, United States, 90717
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
Spring Valley, California, United States, 91978
Novo Nordisk Investigational Site
Tarzana, California, United States, 91356-3551
United States, Colorado
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Florida
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32216
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34744
Novo Nordisk Investigational Site
Saint Petersburg, Florida, United States, 33709
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30339
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30342
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62711
United States, Iowa
Novo Nordisk Investigational Site
Des Moines, Iowa, United States, 50265
United States, Kansas
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40213
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
United States, Mississippi
Novo Nordisk Investigational Site
Olive Branch, Mississippi, United States, 38654-3573
United States, Montana
Novo Nordisk Investigational Site
Butte, Montana, United States, 59701
United States, New Jersey
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27517
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Greenville, North Carolina, United States, 27834
Novo Nordisk Investigational Site
Hickory, North Carolina, United States, 28601
Novo Nordisk Investigational Site
Salisbury, North Carolina, United States, 28144
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Novo Nordisk Investigational Site
Wadsworth, Ohio, United States, 44281-9236
United States, South Carolina
Novo Nordisk Investigational Site
Anderson, South Carolina, United States, 29621
Novo Nordisk Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Novo Nordisk Investigational Site
Bristol, Tennessee, United States, 37620
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
Novo Nordisk Investigational Site
Austin, Texas, United States, 78749
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75231
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Houston, Texas, United States, 77079
Novo Nordisk Investigational Site
Shavano Park, Texas, United States, 78231
United States, Utah
Novo Nordisk Investigational Site
Saint George, Utah, United States, 84790
United States, Virginia
Novo Nordisk Investigational Site
Winchester, Virginia, United States, 22601
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Algeria
Novo Nordisk Investigational Site
Algiers, Algeria, 16000
Novo Nordisk Investigational Site
Oran, Algeria, 31000
Argentina
Novo Nordisk Investigational Site
Caba, Argentina, 1425
Novo Nordisk Investigational Site
Chacabuco, Argentina, B6740ELF
Novo Nordisk Investigational Site
Córdoba, Argentina, X5016KEH
Novo Nordisk Investigational Site
Mendoza, Argentina, 5500
Novo Nordisk Investigational Site
Santiago del Estero, Argentina
Canada, Alberta
Novo Nordisk Investigational Site
Calgary, Alberta, Canada, T2V 4J2
Canada, Newfoundland and Labrador
Novo Nordisk Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Canada, Ontario
Novo Nordisk Investigational Site
Concord, Ontario, Canada, L4K 4M2
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8J 0B6
Novo Nordisk Investigational Site
London, Ontario, Canada, N5W 6A2
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4G 3E8
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M9V 4B4
Canada, Quebec
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H1M 1B1
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H4T 1Z9
Novo Nordisk Investigational Site
St-Marc-des-Carrières, Quebec, Canada, G0A 4B0
Germany
Novo Nordisk Investigational Site
Essen, Germany, 45136
Novo Nordisk Investigational Site
Falkensee, Germany, 14612
Novo Nordisk Investigational Site
Hamburg, Germany, 22041
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Lingen, Germany, 49808
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Schweinfurt, Germany, 97421
Novo Nordisk Investigational Site
Stuttgart, Germany, 70378
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Novo Nordisk Investigational Site
Athens, Greece, GR-12462
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-54636
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-54643
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-57001
Novo Nordisk Investigational Site
Thessaloniki, Greece, GR-57010
India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380007
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380054
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560054
Novo Nordisk Investigational Site
Kochi, Kerala, India, 682041
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400012
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411013
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India, 302020
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600 013
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600086
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India, 641009
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700064
Novo Nordisk Investigational Site
New Delhi, India, 110088
Novo Nordisk Investigational Site
Secunderabad, India, 500 003
Japan
Novo Nordisk Investigational Site
Chiba-shi, Chiba, Japan, 260-0804
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103-0002
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, Japan, 812-8582
Novo Nordisk Investigational Site
Hokkaido, Japan, 060-0062
Novo Nordisk Investigational Site
Hokkaido, Japan, 062-0007
Novo Nordisk Investigational Site
Ibaraki, Japan, 311-0113
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan, 582-0005
Novo Nordisk Investigational Site
Mitaka-shi, Tokyo, Japan, 181-0013
Novo Nordisk Investigational Site
Osaka, Japan, 565-0871
Novo Nordisk Investigational Site
Osaka, Japan, 569-1045
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, Japan, 060-0001
Novo Nordisk Investigational Site
Tochigi, Japan, 323-0022
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00921
Russian Federation
Novo Nordisk Investigational Site
Barnaul, Russian Federation, 656043
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 123448
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127486
Novo Nordisk Investigational Site
Moscow, Russian Federation, 129110
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194291
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 199226
Novo Nordisk Investigational Site
Tomsk, Russian Federation, 634050
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2001
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2013
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0181
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0184
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Brits, North West, South Africa, 0250
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Córdoba, Spain, 14004
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Novo Nordisk Investigational Site
Málaga, Spain, 29010
Novo Nordisk Investigational Site
San Cristóbal de La Laguna, Spain, 38320
Novo Nordisk Investigational Site
Sevilla, Spain, 41003
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valladolid, Spain, 47010
United Arab Emirates
Novo Nordisk Investigational Site
Dubai, United Arab Emirates, 22241
Novo Nordisk Investigational Site
Dubai, United Arab Emirates, 4545
Novo Nordisk Investigational Site
Dubai, United Arab Emirates, 9115
Novo Nordisk Investigational Site
Hatta, United Arab Emirates, 7272
Novo Nordisk Investigational Site
Kalba, United Arab Emirates, 11195
Novo Nordisk Investigational Site
Umm Al Quwain, United Arab Emirates, 24
United Kingdom
Novo Nordisk Investigational Site
Chester, United Kingdom, CH2 1UL
Novo Nordisk Investigational Site
Crewe, United Kingdom, CW5 5NX
Novo Nordisk Investigational Site
Glasgow, United Kingdom, G31 2ER
Novo Nordisk Investigational Site
Harrogate, North Yorkshire, United Kingdom, HG2 7SX
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE5 4PW
Novo Nordisk Investigational Site
Middlesbrough, United Kingdom, TS4 3BW
Novo Nordisk Investigational Site
Soham, United Kingdom, CB7 5JD
Novo Nordisk Investigational Site
Stevenage, United Kingdom, SG1 4AB
Novo Nordisk Investigational Site
Watford, United Kingdom, WD25 7NL
Novo Nordisk Investigational Site
Wellingborough, United Kingdom, NN8 4RW
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03552757     History of Changes
Other Study ID Numbers: NN9536-4374
U1111-1200-8148 ( Other Identifier: World Health Organization (WHO) )
2017-003414-10 ( Other Identifier: European Medicines Agency (EudraCT) )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
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://www.novonordisk-trials.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms