Clinical trial NCT05890976: Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)
Official title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Chinese Adults With Overweight or Obesity (OASIS 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relative Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent
timeFrame: At end of treatment (week 44)
Secondary outcomes:
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
timeFrame: At end of treatment (week 44)
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
timeFrame: At end of treatment (week 44)
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
timeFrame: At end of treatment (week 44)
measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) - Total Score
timeFrame: From randomisation (week 0) to end-of-treatment (week 44)
measure: Change in Body Mass Index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Waist Circumference
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Systolic Blood Pressure
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Diastolic Blood Pressure
timeFrame: From randomisation (week 0) to end of treatment (week 44)
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Fasting Plasma Glucose
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Fasting Serum Insulin
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Total Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in High-density Lipoprotein (HDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Low-density Lipoproteins (LDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Very Low-density Lipoproteins (VLDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Free Fatty Acids
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in waist-height ratio (WtHR)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Number of Treatment Emergent Adverse Events(TEAE's)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Number of Treatment Emergent Serious Adverse Events(TESAE's)
timeFrame: From baseline (week 0) to end of study (week 51)
measure: AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State
timeFrame: Week 20
measure: Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg
timeFrame: Week 20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital-Endocrinology
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University-Endocrinology
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Huizhou
country: China
facility: Huizhou Central People's Hospital-Endocrinology
state: Guangdong
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University-Endocrinology
state: Henan
city: Luo Yang
country: China
facility: The First Affiliated Hospital of Henan University of science and Technology
state: Henan
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde City-Endocrinology
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University-Endocrinology
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital-Endocrinology
state: Shanghai
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University-Endocrinology
state: Tianjin
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: