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

Last updated: March 4, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Semaglutide

Semaglutide Placebo

Clinical Study ID

NCT05890976
NN9932-4861
U1111-1266-2400
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

  • Male or female, age greater than or equal to 18 years at the time of signinginformed 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 1weight-related comorbidity (treated or untreated). Weight-related comorbiditiesshould be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea orcardiovascular disease.

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

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) oractive ingredient, dose and dosing frequency) for at least 60 days prior to the dayof 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

Exclusion Criteria:

Participants without T2D at screening:

  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the centrallaboratory 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. Verifiedby a fundus examination performed by an ophthalmologist or another suitablyqualified health care provider within the past 90 days prior to screening or in theperiod between screening and randomisation. Pharmacological pupil-dilation is arequirement unless using a digital fundus photography camera specified fornon-dilated examination.

  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value oflesser than 30 milli litre per min/1.73 square metre (mL/min/1.73 m^2) according toChronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation asdefined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification bythe central laboratory at screening.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
May 30, 2023
Estimated Completion Date:
January 16, 2025

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Site Not Available

  • Beijing Friendship Hospital, Capital Medical University-Endocrinology

    Beijing, Beijing 100050
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Peking University People's Hospital-Endocrinology

    Beijing, Beijing 100044
    China

    Site Not Available

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing 404000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing 404000
    China

    Site Not Available

  • Huizhou Central People's Hospital

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Huaihe Hospital of Henan University

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Kaifeng, Henan 450000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Luo Yang, Henan 450062
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of science and Technology

    Luo Yang, Henan 450062
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shiyan, Hubei 442008
    China

    Site Not Available

  • Taihe Hospital

    Shiyan, Hubei 442008
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changde, Hunan 415003
    China

    Site Not Available

  • The First People's Hospital of Changde City

    Changde, Hunan 415003
    China

    Site Not Available

  • The First People's Hospital of Changde City-Endocrinology

    Changde, Hunan 415003
    China

    Site Not Available

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • Jinan Central Hospital

    Ji'nan, Shandong 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jin'an, Shandong 250013
    China

    Site Not Available

  • Huashan Hospital Fudan University-Endocrinology

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Shanghai Huashan Hospital, Affiliated to Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Tianjin, Tianjin 300052
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.