We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03693430
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : March 23, 2022
Last Update Posted : March 23, 2022
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

Layout table for study information
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. Percentage Change From Baseline (Week 0) to Week 104 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  2. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: At Week 104 ]
    Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).


Secondary Outcome Measures :
  1. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: At Week 104 ]
    Number of participants who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  2. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: At Week 104 ]
    Number of participants who achieved >=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  3. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: At Week 104 ]
    Number of participants who achieved >=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  4. Change From Baseline (Week 0) to Week 104 in Waist Circumference [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  5. Change From Baseline (Week 0) to Week 104 in Body Weight (kg) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  6. Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  7. Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  8. Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  9. Change in Total Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  10. Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  11. Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  12. Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  13. Change in Free Fatty Acids-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  14. Change in Triglycerides-ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  15. Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  16. Change in Glycated Haemoglobin (HbA1c) (Percent [%]) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  17. Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  18. Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  19. Change From Baseline (Week 0) to Week 104 in FPG (mg/dL) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  20. Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  21. Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL) [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  22. Percentage Change From Baseline (Week 0) to Week 52 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Percentage change in body weight from baseline (week 0) to week 52 is presented.

  23. Change From Baseline (Week 0) to Week 52 in Body Weight (kg) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in body weight from baseline (week 0) to week 52 in kg is presented.

  24. Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI) [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in BMI from baseline (week 0) to week 52 is presented.

  25. Change From Baseline (Week 0) to Week 52 in Waist Circumference [ Time Frame: From Baseline (Week 0) to Week 52 ]
    Change in waist circumference from baseline (week 0) to week 52 is presented.

  26. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss.

  27. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss.

  28. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss.

  29. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20% [ Time Frame: At Week 52 ]
    Number of participants who achieved >=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss.

  30. Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 111 ]
    An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).

  31. Number of Serious Adverse Events (SAEs) [ Time Frame: From Baseline (Week 0) to Week 111 ]
    A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).

  32. Change From Baseline (Week 0) to Week 104 in Pulse [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  33. Change From Baseline (Week 0) to Week 104 in Amylase [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  34. Change From Baseline (Week 0) to Week 104 in Lipase [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  35. Change From Baseline (Week 0) to Week 104 in Calcitonin [ Time Frame: From Baseline (Week 0) to Week 104 ]
    Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).



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:   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
Layout table for location information
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
Layout table for investigator information
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol  [PDF] June 29, 2018
Statistical Analysis Plan  [PDF] April 12, 2021

Publications:
Layout table for additonal information
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
Results First Posted: March 23, 2022
Last Update Posted: March 23, 2022
Last Verified: March 2022
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

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