Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 667
- Locations
- 112
- Primary Endpoint
- Relative change in body weight
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Oral semaglutide placebo
All participants are given once daily dose for 68 weeks
Intervention: Placebo (semaglutide) (Drug)
Oral semaglutide
Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)
Intervention: Oral semaglutide (Drug)
Outcomes
Primary Outcomes
Relative change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 68)
percentage-point
Achievement of body weight reduction greater than or equal to 5% (Yes/No)
Time Frame: At end-of-treatment (week 68)
Count of participants
Secondary Outcomes
- Change in lipids: Total cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 68))
- Number of serious adverse events(From baseline (week 0) to end-of-trial (week 75))
- Change in Short Form-36 (SF-36) Physical Function(From baseline (week 0) to end of treatment (week 68))
- Change in IWQOL-Lite-CT Physical Function(From baseline (week 0) to end of treatment (week 68))
- Change in fasting plasma glucose (FPG)(From baseline (week 0) to end of treatment (week 68))
- Change in lipids: VLDL (very-low density lipoprotein) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change in lipids: Triglycerides(From baseline (week 0) to end of treatment (week 68))
- Number of treatment emergent adverse events(From baseline (week 0) to end-of-trial (week 75))
- Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 68))
- Change in diastolic blood pressure(From randomisation (week 0) to end of treatment (week 68))
- Change in lipids: HDL (high density lipoprotein) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Achievement of body weight reduction greater than or equal to 15% (Yes/No)(At end of treatment (week 68))
- Change in systolic blood pressure(From baseline (week 0) to end of treatment (week 68))
- Change in fasting serum insulin(From baseline (week 0) to end of treatment (week 68))
- Change in HbA1c (glycated haemoglobin)(From baseline (week 0) to end of treatment (week 68))
- Change in high sensitivity C-Reactive Protein(From baseline (week 0) to end of treatment (week 68))
- Achievement of body weight reduction greater than or equal to 10% (Yes/No)(At end of treatment (week 68))
- Achievement of body weight reduction greater than or equal to 20% (Yes/No)(At end of treatment (week 68))
- Change in lipids: LDL (low-density lipoprotein) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change in lipids: Free fatty acids(From baseline (week 0) to end of treatment (week 68))