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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 : Recruiting
First Posted : June 7, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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 will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Overweight or Obesity Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1950 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 in Subjects With Overweight or Obesity
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : September 23, 2019
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide s.c. 2.4 mg once weekly
Participants will receive semaglutide for 68 weeks.
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.

Placebo Comparator: Semaglutide placebo
Participants will receive semaglutide matching placebo for 68 weeks.
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.




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

  2. Subjects who achieve 5 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ]
    Number of subjects.


Secondary Outcome Measures :
  1. Subjects who achieve 10 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ]
    Number of subjects.

  2. Subjects who achieve 15 or more percent body weight reduction (yes/no) [ Time Frame: Week 68 ]
    Number of subjects.

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

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

  5. 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.

  6. 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.

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

  8. Change in body mass index (BMI) [ Time Frame: Week 0, Week 68 ]
    Measured in kg/m2

  9. Change in glycated haemoglobin (HbA1C) [ Time Frame: Week 0, Week 68 ]
    Measured in %.

  10. Change in HbA1C [ Time Frame: Week 0, Week 68 ]
    Measured in mmol/mol.

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

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

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

  14. 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.

  15. Change in high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, Week 68 ]
    Measured in mg/L.

  16. Change in plasminogen activator inhibitor-1 (PAI-1) activity [ Time Frame: Week 0, Week 68 ]
    Measured in AU/mL.

  17. Change in soluble leptin receptor [ Time Frame: Week 0, Week 68 ]
    Measured in ng/mL.

  18. Change in leptin [ Time Frame: Week 0, Week 68 ]
    Measured in ng/mL.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. Change in body composition (total fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by dual energy X-ray absorpmetry (DEXA). Measured in %.

  32. Change in body composition (total fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in g.

  33. Change in body composition (lean body mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in %.

  34. Change in body composition (lean body mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in g.

  35. Change in body composition (visceral fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in %.

  36. Change in body composition (visceral fat mass) [ Time Frame: Week 0, Week 68 ]
    Assessed by DEXA. Measured in g.

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

  38. 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.

  39. Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0 to 75 ]
    Number of events.

  40. Number of serious adverse events (SAEs) [ Time Frame: Weeks 0 to 75 ]
    Number of events.

  41. Change in pulse [ Time Frame: Week 0, Week 68 ]
    Measured in bpm.

  42. Change in amylase [ Time Frame: Week 0, Week 68 ]
    Measured in U/L.

  43. Change in lipase [ Time Frame: Week 0, Week 68 ]
    Measured in U/L.

  44. Change in calcitonin [ Time Frame: Week 0, Week 68 ]
    Measured in ng/L.



Information from the National Library of Medicine

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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 greater than or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) greater than or equal to 30 kg/sqm or greater than or equal to 27 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

Exclusion Criteria:

  • 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

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): NCT03548935


Contacts
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03548935     History of Changes
Other Study ID Numbers: NN9536-4373
U1111-1200-8053 ( Other Identifier: World Health Organization (WHO) )
2017-003436-36 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
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/sharing-results

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obesity
Overweight
Nutrition Disorders
Overnutrition
Body Weight
Signs and Symptoms