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Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (STEP 8)

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: NCT04074161
Recruitment Status : Active, not recruiting
First Posted : August 29, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency.

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Primary Purpose: Treatment
Official Title: Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : April 8, 2021
Estimated Study Completion Date : May 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Semaglutide
Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
Drug: Semaglutide
Dose gradually increased to 2.4 mg administered once weekly for 68 weeks

Placebo Comparator: Placebo (semaglutide)
Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Drug: Placebo (semaglutide)
Administered once weekly for 68 weeks

Active Comparator: Liraglutide
Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Drug: Liraglutide
Dose gradually increased to 3.0 mg administered once daily for 68 weeks

Placebo Comparator: Placebo (liraglutide)
Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Drug: Placebo (liraglutide)
Administered once daily for 68 weeks




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: From baseline (week 0) to week 68 ]
    Percent


Secondary Outcome Measures :
  1. Subject who achieves body weight reduction equal to or above 10% (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
    Number of participants

  2. Subject who achieves body weight reduction equal to or above 15% (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
    Number of participants

  3. Subject who achieves body weight reduction equal to or above 20% (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
    Number of participants

  4. Change in waist circumference [ Time Frame: From baseline (week 0) to week 68 ]
    cm

  5. Change in body weight (semaglutide s.c. 2.4 mg once-weekly versus placebo and liraglutide s.c. 3.0 mg once-daily versus placebo) [ Time Frame: From baseline (week 0) to week 68 ]
    Percent

  6. Change in systolic blood pressure [ Time Frame: From baseline (week 0) to week 68 ]
    mmHg

  7. Change in total cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  8. Change in high density lipoprotein (HDL) cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  9. Change in low density lipoprotein (LDL) cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  10. Change in very low density lipoprotein (VLDL) cholesterol [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  11. Change in free fatty acids (FFA) [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  12. Change in triglycerides [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  13. Change in high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: From baseline (week 0) to week 68 ]
    mg/L

  14. Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 68 ]
    Percent

  15. Change in fasting plasma glucose [ Time Frame: From baseline (week 0) to week 68 ]
    mg/dL

  16. Change in glycaemic category (normo-glycaemia, pre-diabetes, T2D) [ Time Frame: From baseline (week 0) to week 68 ]
    Number of participants

  17. Subjects who have permanently discontinued randomised trial product (yes/no) [ Time Frame: From baseline (week 0) to week 68 ]
    Number of participants

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

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



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.


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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 18 years or older at the time of signing informed consent
  • Body mass index (BMI) equal to or above 30.0 kg/m^2 or equal to or above 27.0 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 equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes mellitus
  • A self-reported change in body weight of 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): NCT04074161


Locations
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United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Novo Nordisk Investigational Site
Fullerton, California, United States, 92835
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
United States, Florida
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32205
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Novo Nordisk Investigational Site
Evanston, Illinois, United States, 60201-2477
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
United States, North Carolina
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104-3317
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Rockwall, Texas, United States, 75032
United States, Virginia
Novo Nordisk Investigational Site
Arlington, Virginia, United States, 22206
Novo Nordisk Investigational Site
Winchester, Virginia, United States, 22601-3834
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04074161    
Other Study ID Numbers: NN9536-4576
U1111-1233-0977 ( Other Identifier: World Health Organization (WHO) )
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
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
Signs and Symptoms
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists