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Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 4)

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ClinicalTrials.gov Identifier: NCT03548987
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This study will look at the change in 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 medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The 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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1060 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 Who Have Reached Target Dose During run-in Period
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : February 3, 2020
Estimated Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.

Maintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68).

The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Drug: Semaglutide
Subcutaneous (under the skin) injection of semaglutide once-weekly.

Placebo Comparator: Placebo

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.

Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68).

The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Drug: Semaglutide
Subcutaneous (under the skin) injection of semaglutide once-weekly.

Drug: Placebo
Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.




Primary Outcome Measures :
  1. Change from randomisation to week 68 in body weight (%) [ Time Frame: Randomization (week 20), week 68 ]
    Measured in %


Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: Randomization (week 20), week 68 ]
    Measured in cm

  2. Change in systolic blood pressure [ Time Frame: Randomization (week 20), week 68 ]
    Measured in mmHg

  3. Change in physical functioning score (Short Form 36 [SF-36]) [ Time Frame: Randomization (week 20), 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.

  4. Change in Total score (Weight Related Sign and Symptom Measure[WRSSM]) [ Time Frame: Randomization (week 20), week 68 ]
    The WRSSM measures the presence and bothersomeness of 10 weight-related symptoms. The tool assesses the multifaceted aspects of obesity on symptom experience.

  5. Change in body weight [ Time Frame: Randomisation (week 20), week 68 ]
    Measured in kg

  6. Change in body mass index (BMI) [ Time Frame: Randomization (week 20), week 68 ]
    Measured in kg/sqm

  7. Change in haemoglobin A1c (HbA1c) [ Time Frame: Randomization (week 20), week 68 ]
    measured in %

  8. Change in HbA1c [ Time Frame: Randomization (week 20), week 68 ]
    measured in mmol/mol

  9. Change in fasting plasma glucose [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  10. Change in fasting serum insulin [ Time Frame: Randomization (week 20), week 68 ]
    measured in mIU/L

  11. Change in diastolic blood pressure [ Time Frame: Randomization (week 20), week 68 ]
    measured in mmHg

  12. Change in total cholesterol [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  13. Change in high-density lipoproteins (HDL) [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  14. Change in low-density lipoproteins (LDL) [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  15. Change in very low-density lipoproteins (VLDL) [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  16. Change in free fatty acids [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  17. Change in triglycerides [ Time Frame: Randomization (week 20), week 68 ]
    measured in mg/dL

  18. Change in SF-36 role-physical score [ Time Frame: Randomization (week 20), 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.

  19. Change in SF-36 bodily pain score [ Time Frame: Randomization (week 20), 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 general health score [ Time Frame: Randomization (week 20), 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 vitality score [ Time Frame: Randomization (week 20), 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 social functioning score [ Time Frame: Randomization (week 20), 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 role-emotional score [ Time Frame: Randomization (week 20), 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 mental health score [ Time Frame: Randomization (week 20), 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 physical component summary [ Time Frame: Randomization (week 20), 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 mental component summary [ Time Frame: Randomization (week 20), 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. Subjects who achieve (yes/no): Responder definition value for SF-36 physical functioning score [ Time Frame: From randomisation (week 20) to 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. Subjects who achieve (yes/no): Responder definition value for WRSSM total score [ Time Frame: From randomisation (week 20) to week 68 ]
    The WRSSM measures the presence and bothersomeness of 10 weight-related symptoms. The tool assesses the multifaceted aspects of obesity on symptom experience.

  29. Subjects who gain weight (yes/no) [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subject

  30. Change in body weight [ Time Frame: week 0, week 68 ]
    Measured in %

  31. Subjects who achieve (yes/no): Body weight reduction < 0% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects

  32. Subjects who achieve (yes/no): Body weight reduction ≥ 5% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects

  33. Subjects who achieve (yes/no): Body weight reduction ≥ 10% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects

  34. Subjects who achieve (yes/no): Body weight reduction ≥ 15% [ Time Frame: From randomisation (week 20) to week 68 ]
    Number of subjects

  35. Number of treatment-emergent adverse events (AEs) [ Time Frame: From week 0 to randomisation (week 20) ]
    count of events

  36. Number of serious adverse events (SAEs) [ Time Frame: From week 0 to randomisation (week 20) ]
    count of events

  37. Change in pulse [ Time Frame: week 0, randomisation (week 20) ]
    Measured in beats per minutes

  38. Change in amylase [ Time Frame: week 0, randomization (week 20) ]
    measured in U/L

  39. Change in lipase [ Time Frame: week 0, randomization (week 20) ]
    measured in U/L

  40. Change in calcitonin [ Time Frame: week 0, randomization (week 20) ]
    measured in ng/L

  41. Number of treatment-emergent AEs [ Time Frame: From randomisation (week 20) to week 75 ]
    count of events

  42. Number of Number of SAEs [ Time Frame: From randomisation (week 20) to week 75 ]
    count of events

  43. Change in pulse [ Time Frame: From randomisation (week 20) to week 75 ]
    Measured in beats per minutes

  44. Change in amylase [ Time Frame: From randomisation (week 20) to week 75 ]
    measured in U/L

  45. Change in lipase [ Time Frame: From randomisation (week 20) to week 75 ]
    measured in U/L

  46. Change in calcitonin [ Time Frame: From randomisation (week 20) to week 75 ]
    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.


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 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:

  • Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening
  • A self-reported change in body weight more 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): NCT03548987


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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03548987     History of Changes
Other Study ID Numbers: NN9536-4376
U1111-1201-0898 ( Other Identifier: World Health Organization (WHO) )
2017-003473-34 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 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