Phase 3 · Semaglutide

OASIS 2 trial results

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity

Percent Change From Baseline in Body Weight (Percent change of body weight), Baseline (week 0), week 68. Oral Semaglutide 50 mg: -14.9; Oral Semaglutide Placebo: -1.5.

Participants
201
Status
completed
Completed
2023-09-01
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT05132088), updated at source Aug 14, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What OASIS 2 measured first

Percent Change From Baseline in Body WeightPercent change of body weight · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
-14.9(9.5)-1.5(5.0)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)Participants · At week 68 · count of participants
MeasureOral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
Yes10711
No2053
Side effects by arm

Side effects in OASIS 2

Percent of participants affected, Week 0 to week 75. The most common events the registry lists.

EventOral Semaglutide 50 mgOral Semaglutide Placebo
Any serious event6%9.1%
COVID-1930.6%33.3%
Nausea25.4%7.6%
Nasopharyngitis11.2%22.7%
Constipation20.9%9.1%
Diarrhoea16.4%9.1%
Pyrexia11.9%15.2%
Vomiting14.9%3%
Tooth fracture0.7%9.1%
Arthralgia7.5%3%
Hyperaesthesia7.5%0%
Back pain6.7%6.1%
Malaise6.7%1.5%
Dental caries1.5%6.1%
Gastroenteritis6%6.1%
Ligament sprain1.5%6.1%
Dizziness6%1.5%
Abdominal pain upper5.2%1.5%
Decreased appetite5.2%0%
Gastrooesophageal reflux disease5.2%1.5%
Myalgia5.2%3%
Secondary outcomes

What else it measured

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)Participants · At week 68 · count of participants
MeasureOral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
Yes836
No4458
Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) ScoreScore on a scale · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=129Oral Semaglutide Placebon=62
7.6(19.5)1.9(15.2)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)Participants · At week 68 · count of participants
MeasureOral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
Yes600
No6764
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)Participants · At week 68 · count of participants
MeasureOral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
Yes410
No8664
Change From Baseline in Body Mass Index (BMI)Kilogram per square meter (kg/m^2) · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
-4.89(3.18)-0.47(1.71)
Change From Baseline in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) GuidelineCentimeter (cm) · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
-11.2(8.2)-1.4(4.4)
Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (%)Percentage change of VFA · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=50Oral Semaglutide Placebon=20
-35.1(31.3)0.6(21.4)
Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (Centimeter Square [cm^2])Centimeter square (cm^2) · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=50Oral Semaglutide Placebon=20
-0.06(0.15)0.02(0.12)
Change From Baseline in Systolic Blood PressureMillimeters of mercury (mmHg) · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
-11(14)-2(13)
Change From Baseline in Diastolic Blood PressureMillimeters of mercury (mmHg) · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=127Oral Semaglutide Placebon=64
-6(10)-1(11)
Change From Baseline in Glycosylated Haemoglobin (HbA1c)Change in HbA1c (%) · Baseline (week 0), week 68 · mean
Oral Semaglutide 50 mgn=126Oral Semaglutide Placebon=64
-0.8(0.8)-0.0(0.7)
Change From Baseline in Total Cholesterol: Ratio to BaselineRatio of total cholesterol · Baseline (week 0), week 68 · geometric mean
Oral Semaglutide 50 mgn=126Oral Semaglutide Placebon=63
0.92(14.6)1.02(14.2)
The trial

How OASIS 2 was run

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. 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.

  • oral semaglutide 50 mg once daily: All participants will get semaglutide or placebo tablets, 1 tablet every morning.
  • oral semaglutide placebo once daily: All participants will get semaglutide or placebo tablets, 1 tablet every morning.
Who could join the trial

Inclusion criteria: 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: * 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 Exclusion criteria: 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: * 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...

Published papers

Papers from OASIS 2

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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