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Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 5)

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ClinicalTrials.gov Identifier: NCT03693430
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : April 19, 2021
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. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets 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 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: Semaglutide Drug: Placebo (Semaglutide) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : January 29, 2021
Actual Study Completion Date : March 23, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide
Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Semaglutide
Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Placebo Comparator: Placebo
Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Drug: Placebo (Semaglutide)
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 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 104 ]
    Measured in %

  2. Subjects who achieve (yes/no): body weight reduction more than or equal to 5% [ Time Frame: Week 0, week 104 ]
    Number of subjects


Secondary Outcome Measures :
  1. Subjects who achieve (yes/no): body weight reduction more than or equal to 10% [ Time Frame: Week 0, week 104 ]
    Number of subjects

  2. Subjects who achieve (yes/no): body weight reduction more than or equal to 15% [ Time Frame: Week 0, week 104 ]
    Number of subjects

  3. Change in waist circumference [ Time Frame: Week 0, week 104 ]
    Measured in cm

  4. Change in systolic blood pressure [ Time Frame: Week 0, week 104 ]
    Measured in mmHg

  5. Change in body weight [ Time Frame: Week 0, week 104 ]
    Measured in kg

  6. Change in body mass index (BMI) [ Time Frame: Week 0, week 104 ]
    Measured in kg/m^2

  7. Change in hemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 104 ]
    Measured in %

  8. Change in HbA1c [ Time Frame: Week 0, week 104 ]
    Measured in mmol/mol

  9. Change in fasting plasma glucose [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  10. Change in fasting serum insulin [ Time Frame: Week 0, week 104 ]
    Measured in micro IU/mL

  11. Change in diastolic blood pressure [ Time Frame: Week 0, week 104 ]
    Measured in mmHg

  12. Change in total cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  13. Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  14. Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  15. Change in very low density lipoprotein (VLDL) cholesterol [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  16. Change in free fatty acids [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  17. Change in triglycerides [ Time Frame: Week 0, week 104 ]
    Measured in mg/dL

  18. Change in high sensitivity C-Reactive Protein [ Time Frame: Week 0, week 104 ]
    Measured in mg/L

  19. Change in body weight [ Time Frame: Week 0, week 52 ]
    Measured in %

  20. Change in body weight [ Time Frame: Week 0, week 52 ]
    Measured in kg

  21. Change in BMI [ Time Frame: Week 0, week 52 ]
    Measured in kg/m^2

  22. Change in waist circumference [ Time Frame: Week 0, week 52 ]
    Measured in cm

  23. Subjects who achieve (yes/no): body weight reduction more than or equal to 5% [ Time Frame: Week 0, week 52 ]
    Number of subjects

  24. Subjects who achieve (yes/no): body weight reduction more than or equal to 10% [ Time Frame: Week 0, week 52 ]
    Number of subjects

  25. Subjects who achieve (yes/no): body weight reduction more than or equal to 15% [ Time Frame: Week 0, week 52 ]
    Number of subjects

  26. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Week 0, week 111 ]
    Number of events

  27. Number of serious adverse events (SAEs) [ Time Frame: Week 0, week 111 ]
    Number of events

  28. Change in pulse [ Time Frame: Week 0, week 104 ]
    Measured in beats per minute

  29. Change in amylase [ Time Frame: Week 0, week 104 ]
    Measured in U/L

  30. Change in lipase [ Time Frame: Week 0, week 104 ]
    Measured in U/L

  31. Change in calcitonin [ Time Frame: Week 0, week 104 ]
    Measured in ng/L



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age more than or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 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
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria:

  • HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the 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): NCT03693430


Locations
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United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
United States, Colorado
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Connecticut
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32205
Novo Nordisk Investigational Site
Ocala, Florida, United States, 34471
United States, Missouri
Novo Nordisk Investigational Site
Saint Peters, Missouri, United States, 63303
United States, Montana
Novo Nordisk Investigational Site
Butte, Montana, United States, 59701
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12203
Novo Nordisk Investigational Site
Rochester, New York, United States, 14609
United States, Tennessee
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
United States, Virginia
Novo Nordisk Investigational Site
Arlington, Virginia, United States, 22206
Canada, British Columbia
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3Z 2N6
Canada, New Brunswick
Novo Nordisk Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Nova Scotia
Novo Nordisk Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4G 3E8
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4P 1P2
Canada, Quebec
Novo Nordisk Investigational Site
Montreal, Quebec, Canada, H4N 2W2
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G1V 4G2
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1132
Novo Nordisk Investigational Site
Budapest, Hungary, 1152
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Komarom, Hungary, 2900
Novo Nordisk Investigational Site
Szekszárd, Hungary, 7100
Italy
Novo Nordisk Investigational Site
Bologna, Italy, 40138
Novo Nordisk Investigational Site
Palermo, Italy, 90127
Novo Nordisk Investigational Site
Pisa, Italy, 56124
Novo Nordisk Investigational Site
Rome, Italy, 00168
Novo Nordisk Investigational Site
Siena, Italy, 53100
Spain
Novo Nordisk Investigational Site
Alcorcón, Spain, 28922
Novo Nordisk Investigational Site
Almeria, Spain, 04009
Novo Nordisk Investigational Site
Hospitalet de Llobregat, Spain, 08907
Novo Nordisk Investigational Site
Pamplona, Spain, 31008
Novo Nordisk Investigational Site
Pozuelo de Alarcon, Spain, 28223
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
Publications:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03693430    
Other Study ID Numbers: NN9536-4378
2017-003726-32 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1202-1740 ( Other Identifier: World Health Organization (WHO) )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
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: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight