Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)

Novo Nordisk A/S200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Overweight Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 greater than or equal to 18 years at the time of signing informed consent. * Body mass index (BMI) of 1. greater than or equal to 28.0 kilogram per meter square (kg/m\^2) or 2. 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. * 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.

Locations (16)

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University-Endocrinology

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

Huizhou Central People's Hospital-Endocrinology

Huizhou, Guangdong, China

Huaihe Hospital of Henan University-Endocrinology

Kaifeng, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Taihe Hospital-Endocrinology

Shiyan, Hubei, China

The First People's Hospital of Changde City-Endocrinology

Changde, Hunan, China

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

...and 6 more locations

Outcomes

Primary Outcomes

Relative Change in Body Weight

Measured in percentage (%)

Time frame: From baseline (week 0) to end of treatment (week 44)

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent

Measured as count of participants

Time frame: At end of treatment (week 44)

Secondary Outcomes

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent

Measured as count of participants

Time frame: At end of treatment (week 44)

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

Measured as count of participants

Time frame: At end of treatment (week 44)

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

Measured as count of participants

Time frame: At end of treatment (week 44)

Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain

IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) - Total Score

IWDAQ is a 18-item obesity-specific PRO measure developed to evaluate daily activity limitations associated with excess weight. It uses an adaptive questionnaire design where the participant chooses the three IWDAQ activities they would most like to improve with weight loss and rate the degree of limitations in each of the three activities at baseline. The same three activities are assessed for degree of limitations at follow-up to allow for tracking of activities relevant to each individual.

Time frame: From randomisation (week 0) to end-of-treatment (week 44)

Change in Body Mass Index (BMI)

Measured in kilogram per square meter (kg/m\^2)

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Waist Circumference

Measured in centimeter (cm)

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Systolic Blood Pressure

Measured in millimeter of mercury (mmHg)

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Diastolic Blood Pressure

Measured in mmHg

Time frame: From randomisation (week 0) to end of treatment (week 44)

Change in Glycated Haemoglobin (HbA1c)

Measured in percentage point (%-point)

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Fasting Plasma Glucose

Measured as milligrams per decilitre (mg/dL)

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Fasting Serum Insulin

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Total Cholesterol

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in High-density Lipoprotein (HDL) Cholesterol

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Low-density Lipoproteins (LDL) Cholesterol

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Very Low-density Lipoproteins (VLDL) Cholesterol

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Triglycerides

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in Free Fatty Acids

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in High Sensitivity C-reactive Protein (hsCRP)

Measured as ratio to baseline

Time frame: From baseline (week 0) to end of treatment (week 44)

Change in waist-height ratio (WtHR)

Time frame: From baseline (week 0) to end of treatment (week 44)

Number of Treatment Emergent Adverse Events(TEAE's)

Measured as count of events

Time frame: From baseline (week 0) to end of treatment (week 44)

Number of Treatment Emergent Serious Adverse Events(TESAE's)

Measured as count of events

Time frame: From baseline (week 0) to end of study (week 51)

AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State

Measured as hours\*nanomoles per litre (h\*nmol/L)

Time frame: Week 20

Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg

Measured as nanomoles per litre (nmol/L)

Time frame: Week 20