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Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range (OASIS 4)

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: NCT05564117
Recruitment Status : Active, not recruiting
First Posted : October 3, 2022
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
Actual Study Start Date : October 11, 2022
Estimated Primary Completion Date : March 19, 2024
Estimated Study Completion Date : May 7, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral semaglutide 25 mg
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
 Drug: Semaglutide
Semaglutide tablets orally once daily for 64 weeks.
Placebo Comparator: Oral semaglutide placebo
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
 Drug: Placebo semaglutide
Semaglutide placebo-matching tablets orally once daily for 64 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in percentage (%).

  2. Number of participants who achieve body weight loss equal to or above 5 percent (yes/no) [ Time Frame: At end of treatment (week 64) ]
    Measured as count of participants.


Secondary Outcome Measures :
  1. Number of participants who achieve body weight loss equal to or above 10 percent (yes/no) [ Time Frame: At end of treatment (week 64) ]
    Measured as count of participants.

  2. Number of participants who achieve body weight loss equal to or above 15 percent (yes/no) [ Time Frame: At end of treatment (week 64) ]
    Measured as count of participants.

  3. Number of participants who achieve body weight loss equal to or above 20 percent (yes/no) [ Time Frame: At end of treatment (week 64) ]
    Measured as count of participants.

  4. Change in Impact of Weight on Quality of Life-Lite-Clinical Trials version (IWQOL-Lite-CT) (Physical Function Domain [5-items] Score) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on participant's quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning.

  5. Change in body mass index (BMI) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in kilogram per square meter (kg/m^2).

  6. Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in centimeter (cm).

  7. Change in systolic blood pressure [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in millimeter of mercury (mmHg).

  8. Change in diastolic blood pressure [ Time Frame: From randomisation (week 0) to end of treatment (week 64) ]
    Measured in mmHg.

  9. Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in percentage point (%-point).

  10. Change in lipid: Total cholesterol (ratio to baseline) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in total cholesterol at week 64 will be presented as ratio to baseline.

  11. Change in lipid: High-density lipoprotein (HDL) cholesterol (ratio to baseline) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in HDL cholesterol at week 64 will be presented as ratio to baseline.

  12. Change in lipid: Low-density lipoprotein (LDL) cholesterol (ratio to baseline) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in LDL cholesterol at week 64 will be presented as ratio to baseline.

  13. Change in lipid: Very-low-density lipoprotein (VLDL) cholesterol (ratio to baseline) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in VLDL cholesterol at week 64 will be presented as ratio to baseline.

  14. Change in lipid: Triglycerides (ratio to baseline) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in triglycerides at week 64 will be presented as ratio to baseline.

  15. Change in lipid: Free fatty acids (ratio to baseline) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in free fatty acids at week 64 will be presented as ratio to baseline.

  16. Change in high sensitivity C Reactive Protein [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in high sensitivity C Reactive Protein at week 64 will be presented as ratio to baseline.

  17. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in FPG at week 64 will be presented as ratio to baseline.

  18. Change in fasting serum insulin [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Change from baseline in fasting serum insulin at week 64 will be presented as ratio to baseline.

  19. Number of treatment emergent adverse events [ Time Frame: From baseline (week 0) to end of study (week 71) ]
    Measured as count of events.

  20. Number of treatment emergent serious adverse events [ Time Frame: From baseline (week 0) to end of study (week 71) ]
    Measured as count of events.


Eligibility Criteria
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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:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) of
  • Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
  • Greater than or equal to 30.0 kg/m^2
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
Contacts and Locations
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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): NCT05564117


Locations
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United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Novo Nordisk Investigational Site
Costa Mesa, California, United States, 92627
United States, North Carolina
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
United States, Virginia
Novo Nordisk Investigational Site
Arlington, Virginia, United States, 22206
Novo Nordisk Investigational Site
Winchester, Virginia, United States, 22601
Canada, New Brunswick
Novo Nordisk Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Ontario
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
Germany
Novo Nordisk Investigational Site
Essen, Germany, 45136
Novo Nordisk Investigational Site
Lingen, Germany, 49808
Novo Nordisk Investigational Site
Münster, Germany, 48153
Novo Nordisk Investigational Site
Oldenburg I. Holst, Germany, 23758
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Stuttgart, Germany, 70378
Novo Nordisk Investigational Site
Villingen-Schwenningen, Germany, 78048
Novo Nordisk Investigational Site
Wangen, Germany, 88239
Poland
Novo Nordisk Investigational Site
Legnica, Dolnoslaskie, Poland, 59-220
Novo Nordisk Investigational Site
Siedlce, Masovian, Poland, 08-110
Novo Nordisk Investigational Site
Warsaw, Masovian, Poland, 02-793
Novo Nordisk Investigational Site
Bialystok, Podlaskie, Poland, 15-281
Novo Nordisk Investigational Site
Poznan, Wielkopolskie, Poland, 60-589
Novo Nordisk Investigational Site
Lublin, Poland, 20-412
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency dept. 2834 Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05564117    
Other Study ID Numbers: NN9932-4954
U1111-1271-9056 ( Other Identifier: World Health Organization (WHO) )
2021-006534-40 ( EudraCT Number )
First Posted: October 3, 2022    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on 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