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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)

Primary Purpose

Overweight, Obesity

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo semaglutide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral semaglutide 25 mg

Oral semaglutide placebo

Arm Description

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).

Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.

Outcomes

Primary Outcome Measures

Relative change in body weight
Measured in percentage (%).
Number of participants who achieve body weight loss equal to or above 5 percent (yes/no)
Measured as count of participants.

Secondary Outcome Measures

Number of participants who achieve body weight loss equal to or above 10 percent (yes/no)
Measured as count of participants.
Number of participants who achieve body weight loss equal to or above 15 percent (yes/no)
Measured as count of participants.
Number of participants who achieve body weight loss equal to or above 20 percent (yes/no)
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)
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)
Measured in kilogram per square meter (kg/m^2).
Change in waist circumference
Measured in centimeter (cm).
Change in systolic blood pressure
Measured in millimeter of mercury (mmHg).
Change in diastolic blood pressure
Measured in mmHg.
Change in glycated haemoglobin (HbA1c)
Measured in percentage point (%-point).
Change in lipid: Total cholesterol (ratio to baseline)
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)
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)
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)
Change from baseline in VLDL cholesterol at week 64 will be presented as ratio to baseline.
Change in lipid: Triglycerides (ratio to baseline)
Change from baseline in triglycerides at week 64 will be presented as ratio to baseline.
Change in lipid: Free fatty acids (ratio to baseline)
Change from baseline in free fatty acids at week 64 will be presented as ratio to baseline.
Change in high sensitivity C Reactive Protein
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)
Change from baseline in FPG at week 64 will be presented as ratio to baseline.
Change in fasting serum insulin
Change from baseline in fasting serum insulin at week 64 will be presented as ratio to baseline.
Number of treatment emergent adverse events
Measured as count of events.
Number of treatment emergent serious adverse events
Measured as count of events.

Full Information

First Posted
September 29, 2022
Last Updated
January 24, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05564117
Brief Title
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
Acronym
OASIS 4
Official Title
Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
March 19, 2024 (Anticipated)
Study Completion Date
May 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral semaglutide 25 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Oral semaglutide placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Semaglutide tablets orally once daily for 64 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo semaglutide
Intervention Description
Semaglutide placebo-matching tablets orally once daily for 64 weeks.
Primary Outcome Measure Information:
Title
Relative change in body weight
Description
Measured in percentage (%).
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Number of participants who achieve body weight loss equal to or above 5 percent (yes/no)
Description
Measured as count of participants.
Time Frame
At end of treatment (week 64)
Secondary Outcome Measure Information:
Title
Number of participants who achieve body weight loss equal to or above 10 percent (yes/no)
Description
Measured as count of participants.
Time Frame
At end of treatment (week 64)
Title
Number of participants who achieve body weight loss equal to or above 15 percent (yes/no)
Description
Measured as count of participants.
Time Frame
At end of treatment (week 64)
Title
Number of participants who achieve body weight loss equal to or above 20 percent (yes/no)
Description
Measured as count of participants.
Time Frame
At end of treatment (week 64)
Title
Change in Impact of Weight on Quality of Life-Lite-Clinical Trials version (IWQOL-Lite-CT) (Physical Function Domain [5-items] Score)
Description
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.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in body mass index (BMI)
Description
Measured in kilogram per square meter (kg/m^2).
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in waist circumference
Description
Measured in centimeter (cm).
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in systolic blood pressure
Description
Measured in millimeter of mercury (mmHg).
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in diastolic blood pressure
Description
Measured in mmHg.
Time Frame
From randomisation (week 0) to end of treatment (week 64)
Title
Change in glycated haemoglobin (HbA1c)
Description
Measured in percentage point (%-point).
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in lipid: Total cholesterol (ratio to baseline)
Description
Change from baseline in total cholesterol at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in lipid: High-density lipoprotein (HDL) cholesterol (ratio to baseline)
Description
Change from baseline in HDL cholesterol at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in lipid: Low-density lipoprotein (LDL) cholesterol (ratio to baseline)
Description
Change from baseline in LDL cholesterol at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in lipid: Very-low-density lipoprotein (VLDL) cholesterol (ratio to baseline)
Description
Change from baseline in VLDL cholesterol at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in lipid: Triglycerides (ratio to baseline)
Description
Change from baseline in triglycerides at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in lipid: Free fatty acids (ratio to baseline)
Description
Change from baseline in free fatty acids at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in high sensitivity C Reactive Protein
Description
Change from baseline in high sensitivity C Reactive Protein at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in fasting plasma glucose (FPG)
Description
Change from baseline in FPG at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Change in fasting serum insulin
Description
Change from baseline in fasting serum insulin at week 64 will be presented as ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 64)
Title
Number of treatment emergent adverse events
Description
Measured as count of events.
Time Frame
From baseline (week 0) to end of study (week 71)
Title
Number of treatment emergent serious adverse events
Description
Measured as count of events.
Time Frame
From baseline (week 0) to end of study (week 71)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency dept. 2834
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22206
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Lingen
ZIP/Postal Code
49808
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg I. Holst
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Stuttgart
ZIP/Postal Code
70378
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Villingen-Schwenningen
ZIP/Postal Code
78048
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Legnica
State/Province
Dolnoslaskie
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Siedlce
State/Province
Masovian
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warsaw
State/Province
Masovian
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-281
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-589
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-412
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Learn more about this trial

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

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