search
Back to results

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3) (OASIS 3)

Primary Purpose

Overweight, Obesity

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Semaglutide
Semaglutide Placebo
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 28.0 kilogram per meter square (kg/m^2) or greater than or equal to 24.0 kg/m^2 with greater than or equal to 1 weight-related comorbidity (treated or untreated). Weight-related comorbidities should be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. History of at least one self-reported unsuccessful dietary effort to lose body weight. For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4: Diagnosed with T2D greater than or equal to 180 days prior to screening. Treated with either diet and exercise alone or stable treatment (same drug(s) or active ingredient, dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or glitazone). HbA1c 7.0 - 10.0 percent (53 - 86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening. Exclusion Criteria: Participants without T2D at screening: HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening. History of type 1 or type 2 diabetes. Treatment with glucose-lowering agent(s) within 90 days prior to screening. Participants with T2D at screening: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. Renal impairment measured as estimated glomerular filtration rate (eGFR) value of lesser than 30 milli litre per min/1.73 square metre (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide 50 mg

Semaglutide Placebo

Arm Description

Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 44 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), 25 mg (weeks 13 to 16) and 50 mg (weeks 17 to 44).

Participants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks.

Outcomes

Primary Outcome Measures

Relative Change in Body Weight
Measured in percentage (%)
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent
Measured as count of participants

Secondary Outcome Measures

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
Measured as count of participants
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain
IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score
IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.
Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ)
IWDAQ is a 18-item obesity-specific PRO measure developed to evaluate daily activity limitations associated with excess weight. It uses an adaptive questionnaire design where the participant chooses the three IWDAQ activities they would most like to improve with weight loss and rate the degree of limitations in each of the three activities at baseline. The same three activities are assessed for degree of limitations at follow-up to allow for tracking of activities relevant to each individual.
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 Fasting Plasma Glucose
Measured as milligrams per decilitre (mg/dL)
Change in Fasting Serum Insulin
Measured as ratio to baseline
Change in Total Cholesterol
Measured as ratio to baseline
Change in High-density Lipoprotein (HDL) Cholesterol
Measured as ratio to baseline
Change in Low-density Lipoproteins (LDL) Cholesterol
Measured as ratio to baseline
Change in Very Low-density Lipoproteins (VLDL) Cholesterol
Measured as ratio to baseline
Change in Triglycerides
Measured as ratio to baseline
Change in Free Fatty Acids
Measured as ratio to baseline
Change in High Sensitivity C-reactive Protein (hsCRP)
Measured as ratio to baseline
Number of Treatment Emergent Adverse Events(TEAE's)
Measured as count of events
Number of Treatment Emergent Serious Adverse Events(TESAE's)
Measured as count of events
AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State
Measured as hours*nanomoles per litre (h*nmol/L)
Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg
Measured as nanomoles per litre (nmol/L)

Full Information

First Posted
May 26, 2023
Last Updated
June 23, 2023
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT05890976
Brief Title
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)
Acronym
OASIS 3
Official Title
Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Chinese Adults With Overweight or Obesity (OASIS 3)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
February 14, 2025 (Anticipated)
Study Completion Date
April 4, 2025 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people who are above a healthy weight range to lose weight. Semaglutide tablets are a new medicine being tested to treat people living with excess body weight. Participants will either get semaglutide or placebo once daily morning for 44 weeks. In addition to taking the medicine, participants will have talks with study staff about: Healthy food choices How to be more physically active What participants can do to lose weight This study will last for about 1 year.

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
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 50 mg
Arm Type
Experimental
Arm Description
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 44 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), 25 mg (weeks 13 to 16) and 50 mg (weeks 17 to 44).
Arm Title
Semaglutide Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive semaglutide tablets orally once daily for 44 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide Placebo
Intervention Description
Participants will receive placebo matched to semaglutide.
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 44)
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent
Description
Measured as count of participants
Time Frame
At end of treatment (week 44)
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
Description
Measured as count of participants
Time Frame
At end of treatment (week 44)
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
Description
Measured as count of participants
Time Frame
At end of treatment (week 44)
Title
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
Description
Measured as count of participants
Time Frame
At end of treatment (week 44)
Title
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain
Description
IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score
Description
IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ)
Description
IWDAQ is a 18-item obesity-specific PRO measure developed to evaluate daily activity limitations associated with excess weight. It uses an adaptive questionnaire design where the participant chooses the three IWDAQ activities they would most like to improve with weight loss and rate the degree of limitations in each of the three activities at baseline. The same three activities are assessed for degree of limitations at follow-up to allow for tracking of activities relevant to each individual.
Time Frame
From randomisation (week 0) to end-of-treatment (week 44)
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 44)
Title
Change in Waist Circumference
Description
Measured in centimeter (cm)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Systolic Blood Pressure
Description
Measured in millimeter of mercury (mmHg)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Diastolic Blood Pressure
Description
Measured in mmHg
Time Frame
From randomisation (week 0) to end of treatment (week 44)
Title
Change in Glycated Haemoglobin (HbA1c)
Description
Measured in percentage point (%-point)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Fasting Plasma Glucose
Description
Measured as milligrams per decilitre (mg/dL)
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Fasting Serum Insulin
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Total Cholesterol
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in High-density Lipoprotein (HDL) Cholesterol
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Low-density Lipoproteins (LDL) Cholesterol
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Very Low-density Lipoproteins (VLDL) Cholesterol
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Triglycerides
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Free Fatty Acids
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in High Sensitivity C-reactive Protein (hsCRP)
Description
Measured as ratio to baseline
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Number of Treatment Emergent Adverse Events(TEAE's)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Number of Treatment Emergent Serious Adverse Events(TESAE's)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of study (week 51)
Title
AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State
Description
Measured as hours*nanomoles per litre (h*nmol/L)
Time Frame
Week 20
Title
Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg
Description
Measured as nanomoles per litre (nmol/L)
Time Frame
Week 20

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 28.0 kilogram per meter square (kg/m^2) or greater than or equal to 24.0 kg/m^2 with greater than or equal to 1 weight-related comorbidity (treated or untreated). Weight-related comorbidities should be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. History of at least one self-reported unsuccessful dietary effort to lose body weight. For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4: Diagnosed with T2D greater than or equal to 180 days prior to screening. Treated with either diet and exercise alone or stable treatment (same drug(s) or active ingredient, dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or glitazone). HbA1c 7.0 - 10.0 percent (53 - 86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening. Exclusion Criteria: Participants without T2D at screening: HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening. History of type 1 or type 2 diabetes. Treatment with glucose-lowering agent(s) within 90 days prior to screening. Participants with T2D at screening: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. Renal impairment measured as estimated glomerular filtration rate (eGFR) value of lesser than 30 milli litre per min/1.73 square metre (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
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
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Luo Yang
State/Province
Henan
ZIP/Postal Code
450062
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442008
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changde
State/Province
Hunan
ZIP/Postal Code
415003
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jin'an
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

Learn more about this trial

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)

We'll reach out to this number within 24 hrs