Overweight and ObesityPhase 3OASIS 2NCT05132088
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity
A Phase 3 study testing semaglutide 50 mg in people with Overweight and Obesity, run by Novo Nordisk A/S at 15 sites in 2 countries.
Trial summary
Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants' body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- semaglutide 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 16 Nov 2021to 1 Sep 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all the following criteria apply:
- 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 above 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 greater than or equal to 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2 diabetes (T2D)
- 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:
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- 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), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or thiazolidinediones)
- HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening
Who cannot join
- Participants without T2D only:
- HbA1c greater than or equal to 6.5% (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
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR brlow 15 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
- Participants with T2D at screening only:
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- Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening
- Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this study, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this study
- 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 eGFR value of below 30 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening
- In participants treated with SGLT2i, renal impairment measured as eGFR value of below 60 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening
- The following criteria apply to all participants:
- Obesity-related:
- Treatment with any medication indicated for weight management within 90 days prior to screening
- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening, (2) lap banding, if the band has been removed greater than 1 year prior to screening, (3) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year prior to screening
- Uncontrolled thyroid disease per investigators discretion
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Japan11 sites
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
Toranomon Hospital, Endocrinology and Metabolism
Minato-ku, Tokyo, 105-8470
The University of Osaka Hospital_Metabolic Medicine
Osaka, 565-0871
Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
Osaka, 569-1045
Takatsuki Red Cross Hospital
Osaka, 569-1045
Shinsapporo Seiryou Hospital_General Clinical Department
Sapporo, Hokkaido, 004-0004
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853
Tokyo Center Clinic_Internal Medicine
Tokyo, 103-0028
Tokyo Center Clinic
Tokyo, 103-0028
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004
South Korea4 sites
Kyungpook National University Hospital
Daegu, 41944
Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Kangbuk Samsung Hospital
Seoul, 03181
About this study
Official title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity
Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.
This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.
Read more
Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.
Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning.
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 The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional.
Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.
- Conditions
- Overweight and Obesity
- Being tested
- semaglutide 50 mg, placebo (semaglutide)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutide 50 mgDrug
Participants will have semaglutide for 68 weeks and will have 1 tablet every morning.
Dose gradually increased to 50 mg.
placebo (semaglutide)Drug
Participants will have placebo tablets for 68 weeks and will have 1 tablet every morning.
| Study group | Role | What they receive |
|---|---|---|
| oral semaglutide 50 mg once daily | Experimental | All participants will get semaglutide or placebo tablets, 1 tablet every morning. Receives: Drug: semaglutide 50 mg |
| oral semaglutide placebo once daily | Placebo comparator | All participants will get semaglutide or placebo tablets, 1 tablet every morning. Receives: Drug: placebo (semaglutide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
Percent change in body weight from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Measured: Baseline (week 0), week 68
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)
Number of participants who achieved >=5% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Measured: At week 68
Secondary outcomes (20)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)
Number of participants who achieved >=10% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Measured: At week 68
Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for 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 patient'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. Results for Physical Function Domain are presented in this outcome measure. The outcome measure was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Measured: Baseline (week 0), week 68
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)
Number of participants who achieved >=15% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction. The outcome measure was evaluated based on in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: At week 68
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)
Number of participants who achieved >=20% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction. The outcome measure was evaluated based on in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: At week 68
Change From Baseline in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
Change in waist circumference measured according to JASSO guideline from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (%)
Change in VFA measured by CT Scan in a subset of the japanese study population from baseline (week 0) to week 68 is presented in %. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (Centimeter Square [cm^2])
Change in VFA measured by CT Scan in a subset of the japanese study population from baseline (week 0) to week 68 is presented in cm^2. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Total Cholesterol: Ratio to Baseline
Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in High-Density Lipoproteins (HDL): Ratio to Baseline
Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Low-Density Lipoproteins (LDL): Ratio to Baseline
Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Very Low-Density Lipoproteins (VLDL): Ratio to Baseline
Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Triglycerides: Ratio to Baseline
Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in Free Fatty Acids: Ratio to Baseline
Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Measured: Baseline (week 0), week 68
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) : Ratio to Baseline
Change in hsCRP measured as milligrams per liter (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Measured: Baseline (week 0), week 68
Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment: the date of first trial product administration (week 0) to the date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days. For the evaluation of adverse events the lag time for each on-treatment time interval is 7 weeks.
Measured: Week 0 to week 75
Number of Serious Adverse Events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the date of first trial product administration (week 0) to the date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days. For the evaluation of adverse events the lag time for each on-treatment time interval is 7 weeks.
Measured: Week 0 to week 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start16 Nov 2021
- Primary completion11 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132088
- Sponsor's protocol ID
- NN9932-4738
- Other IDs
- U1111-1258-7561
- Acronym
- OASIS 2
- Status last verified
- Aug 2026
- First submitted
- 11 Nov 2021
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Publications
Kadowaki T, Heftdal LD, Ko HJ, Overvad M, Shimomura I, Thamattoor UK, Kim KK; OASIS 2 Investigators. Oral Semaglutide in an East Asian Population With Overweight or Obesity, With or Without Type 2 Diabetes: The OASIS 2 Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 1;185(10):1206-1217. doi: 10.1001/jamainternmed.2025.3599.
PubMed 40758358