Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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.
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Male or female, age greater than or equal to 18 years at the time of signing informed consent.
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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.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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