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

Obesity Clinical Trial

— OASIS 3  

Official title:

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Chinese Adults With Overweight or Obesity (OASIS 3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890976
• Other study ID #: NN9932-4861
• Secondary ID: U1111-1266-2400
• Status: Recruiting
• Phase: Phase 3
• Start date: May 30, 2023
• Est. completion date: April 4, 2025

Study information

• Verified date: June 2023
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: April 4, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a-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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Semaglutide
Participants will receive semaglutide tablets orally once daily for 44 weeks.
• Semaglutide Placebo
Participants will receive placebo matched to semaglutide.

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing	Beijing
China	Novo Nordisk Investigational Site	Beijing	Beijing
China	Novo Nordisk Investigational Site	Changde	Hunan
China	Novo Nordisk Investigational Site	Changzhou	Jiangsu
China	Novo Nordisk Investigational Site	Chongqing	Chongqing
China	Novo Nordisk Investigational Site	Huizhou	Guangdong
China	Novo Nordisk Investigational Site	Jin'an	Shandong
China	Novo Nordisk Investigational Site	Kaifeng	Henan
China	Novo Nordisk Investigational Site	Luo Yang	Henan
China	Novo Nordisk Investigational Site	Nanjing	Jiangsu
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shiyan	Hubei
China	Novo Nordisk Investigational Site	Tianjin	Tianjin
China	Novo Nordisk Investigational Site	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Change in Body Weight	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 44)
Primary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent	Measured as count of participants	At end of treatment (week 44)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent	Measured as count of participants	At end of treatment (week 44)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent	Measured as count of participants	At end of treatment (week 44)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent	Measured as count of participants	At end of treatment (week 44)
Secondary	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.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score	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.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ)	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.	From randomisation (week 0) to end-of-treatment (week 44)
Secondary	Change in Body Mass Index (BMI)	Measured in kilogram per square meter (kg/m^2)	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Waist Circumference	Measured in centimeter (cm)	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Systolic Blood Pressure	Measured in millimeter of mercury (mmHg)	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Diastolic Blood Pressure	Measured in mmHg	From randomisation (week 0) to end of treatment (week 44)
Secondary	Change in Glycated Haemoglobin (HbA1c)	Measured in percentage point (%-point)	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Fasting Plasma Glucose	Measured as milligrams per decilitre (mg/dL)	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Fasting Serum Insulin	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Total Cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in High-density Lipoprotein (HDL) Cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Low-density Lipoproteins (LDL) Cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Very Low-density Lipoproteins (VLDL) Cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Triglycerides	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Free Fatty Acids	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in High Sensitivity C-reactive Protein (hsCRP)	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 44)
Secondary	Number of Treatment Emergent Adverse Events(TEAE's)	Measured as count of events	From baseline (week 0) to end of treatment (week 44)
Secondary	Number of Treatment Emergent Serious Adverse Events(TESAE's)	Measured as count of events	From baseline (week 0) to end of study (week 51)
Secondary	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)	Week 20
Secondary	Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg	Measured as nanomoles per litre (nmol/L)	Week 20