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

NCT05890976 | Completed Phase 3 FDA Drug

• 2 other identifiers: NN9932-4861U1111-1266-2400
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 16

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Relative Change in Body Weight

  Measured in percentage (%)

  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

  At end of treatment (week 44)

Secondary Outcomes (25)

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

  At end of treatment (week 44)

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

  At end of treatment (week 44)

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

  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

  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

  From baseline (week 0) to end of treatment (week 44)

Study Arms (2)

Semaglutide 50 mg

EXPERIMENTAL

Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 44 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), 25 mg (weeks 13 to 16) and 50 mg (weeks 17 to 44).

Drug: Semaglutide

Semaglutide Placebo

PLACEBO COMPARATOR

Participants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks.

Drug: Semaglutide Placebo

Interventions

Semaglutide DRUG

Participants will receive semaglutide tablets orally once daily for 44 weeks.

Semaglutide 50 mg

Semaglutide Placebo DRUG

Participants will receive placebo matched to semaglutide.

Semaglutide Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (16)

Peking University People's Hospital-Endocrinology

Beijing, Beijing Municipality, 100044, China

Location

Beijing Friendship Hospital, Capital Medical University-Endocrinology

Beijing, Beijing Municipality, 100050, China

Location

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

Huizhou Central People's Hospital-Endocrinology

Huizhou, Guangdong, 516001, China

Location

Huaihe Hospital of Henan University-Endocrinology

Kaifeng, Henan, 475000, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 450062, China

Location

Taihe Hospital-Endocrinology

Shiyan, Hubei, 442008, China

Location

The First People's Hospital of Changde City-Endocrinology

Changde, Hunan, 415003, China

Location

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213003, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

The Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

Location

Jinan Central Hospital

Ji'nan, Shandong, 250013, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Huashan Hospital Fudan University-Endocrinology

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Pudong New Area People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 201200, China

Location

General Hospital of Tianjin Medical University-Endocrinology

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: May 30, 2023
• Primary Completion: January 16, 2025
• Study Completion: January 16, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (16)