Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
NCT ID: NCT04074161
Last Updated: 2023-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
338 participants
INTERVENTIONAL
2019-09-11
2021-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Study Groups
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Semaglutide
Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
Semaglutide
Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
Placebo (semaglutide)
Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Placebo (semaglutide)
Administered once weekly for 68 weeks
Liraglutide
Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Liraglutide
Dose gradually increased to 3.0 mg administered once daily for 68 weeks
Placebo (liraglutide)
Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Placebo (liraglutide)
Administered once daily for 68 weeks
Interventions
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Semaglutide
Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
Placebo (semaglutide)
Administered once weekly for 68 weeks
Liraglutide
Dose gradually increased to 3.0 mg administered once daily for 68 weeks
Placebo (liraglutide)
Administered once daily for 68 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Fullerton, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Plantation, Florida, United States
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States
Novo Nordisk Investigational Site
Evanston, Illinois, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, United States
Novo Nordisk Investigational Site
Albany, New York, United States
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Rockwall, Texas, United States
Novo Nordisk Investigational Site
Arlington, Virginia, United States
Novo Nordisk Investigational Site
Winchester, Virginia, United States
Novo Nordisk Investigational Site
Olympia, Washington, United States
Countries
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References
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Wharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29.
Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619.
Snitker S, Egebjerg C, Frederiksen M, Sparre T. Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial. Diabetes Obes Metab. 2022 Nov;24(11):2273-2276. doi: 10.1111/dom.14809. Epub 2022 Aug 7. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1233-0977
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-4576
Identifier Type: -
Identifier Source: org_study_id
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