Phase 3
N=667
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Obesity · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT05035095 ↗Enrolled (actual)
667
Serious AEs
9.2%
Results posted
May 2026
Primary outcome: Primary: Percentage Change in Body Weight — -15.8; -2.2 Percentage (%) change in body weight — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oral semaglutide (Drug); Placebo (semaglutide) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Body Weight |
-15.8; -2.2 | <0.0001 sig |
| PRIMARY Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No) |
269; 76; 48; 219 | <0.0001 sig |
| SECONDARY Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No) |
220; 35; 97; 260 | — |
| SECONDARY Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No) |
170; 17; 147; 278 | — |
| SECONDARY Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No) |
107; 8; 210; 287 | — |
| SECONDARY Change in Waist Circumference |
-13.4; -2.8 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-5.9; -0.9 | — |
| SECONDARY Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function |
14.5; 5.0 | — |
| SECONDARY Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain |
2.4; -0.0 | — |
| SECONDARY Change in Systolic Blood Pressure |
-7; -1 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-2; -1 | — |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.2; 0.1 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-10.3; -1.8 | — |
| SECONDARY Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline |
0.67; 0.94 | — |
| SECONDARY Change in Total Cholesterol (mg/dL) - Ratio to Baseline |
0.97; 1.01 | — |
| SECONDARY Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline |
1.05; 1.01 | — |
| SECONDARY Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline |
0.98; 1.03 | — |
| SECONDARY Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline |
0.77; 0.96 | — |
| SECONDARY Change in Triglycerides (mg/dL) - Ratio to Baseline |
0.77; 0.96 | — |
| SECONDARY Change in Free Fatty Acids (mg/dL) - Ratio to Baseline |
0.87; 1.00 | — |
| SECONDARY Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline |
0.42; 0.85 | — |
| SECONDARY Number of Treatment Emergent Adverse Events |
2500; 1577 | — |
| SECONDARY Number of Serious Adverse Events |
44; 48 | — |
| SECONDARY Change in Body Weight - Kilogram (Kg) |
-16.1; -2.4 | — |
| SECONDARY Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no) |
129; 19; 165; 249 | — |
| SECONDARY Change in Pulse |
4; -0 | — |
| SECONDARY Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes) |
200; 200; 132; 130; 2; 3 | — |
| SECONDARY Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No) |
149; 87; 149; 191 | — |
| SECONDARY Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No) |
113; 56; 190; 224 | — |
Summary
This study is being conducted 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 doctor. Blood samples will be taken at 10 visits.
Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.
Eligibility Criteria
Inclusion Criteria
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI):
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 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
- HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Data sourced from ClinicalTrials.gov (NCT05035095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.