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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

Tracking Information
First Submitted Date  ICMJE September 29, 2022
First Posted Date  ICMJE October 3, 2022
Last Update Posted Date January 25, 2023
Actual Study Start Date  ICMJE October 11, 2022
Estimated Primary Completion Date March 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2022)
  • Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in percentage (%).
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in centimeter (cm).
  • Change in systolic blood pressure [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in millimeter of mercury (mmHg).
  • Change in diastolic blood pressure [ Time Frame: From randomisation (week 0) to end of treatment (week 64) ]
    Measured in mmHg.
  • Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 64) ]
    Measured in percentage point (%-point).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of treatment emergent adverse events [ Time Frame: From baseline (week 0) to end of study (week 71) ]
    Measured as count of events.
  • Number of treatment emergent serious adverse events [ Time Frame: From baseline (week 0) to end of study (week 71) ]
    Measured as count of events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Official Title  ICMJE Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • Drug: Semaglutide
    Semaglutide tablets orally once daily for 64 weeks.
  • Drug: Placebo semaglutide
    Semaglutide placebo-matching tablets orally once daily for 64 weeks.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Oral semaglutide placebo
    Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
    Intervention: Drug: Placebo semaglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 23, 2023)
281
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2022)
300
Estimated Study Completion Date  ICMJE May 7, 2024
Estimated Primary Completion Date March 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05564117
Other Study ID Numbers  ICMJE NN9932-4954
U1111-1271-9056 ( Other Identifier: World Health Organization (WHO) )
2021-006534-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Transparency dept. 2834 Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP