Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity

Last updated: June 27, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

placebo (semaglutide)

semaglutide 50 mg

Clinical Study ID

NCT05132088
NN9932-4738
U1111-1258-7561
  • Ages > 18
  • All Genders

Study Summary

Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning.

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 The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional.

Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.

Eligibility Criteria

Inclusion

Inclusion criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

  • 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 above or equal to 18 years at the time of signing informedconsent

  • Body mass index (BMI) of greater than or equal to 27.0 kg/m^2 with greater than orequal to 2 weight related comorbidities (treated or untreated) according to theJASSO guideline or BMI greater than or equal to 35.0 kg/m^2 with greater than orequal to1 weight related comorbidity (treated or untreated) according to the JASSOguideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2diabetes (T2D)

  • 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), doseand dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucoseco-transporter 2 inhibitor) or thiazolidinediones)

  • HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratoryat screening

Exclusion

Exclusion criteria:

Participants without T2D only:

  • HbA1c greater than or equal to 6.5% (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

  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value ofeGFR brlow 15 ml/min/1.73 m^2 according to Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) creatinine equation as defined by kidney disease improvingglobal outcomes (KDIGO) 2012 classification by the central laboratory at screening

Participants with T2D at screening only:

  • Treatment with any medication for the indication of diabetes other than stated inthe inclusion criteria within the past 60 days prior to screening

  • Receipt of any other anti-diabetic investigational drug within 90 days prior toscreening for this study, or receipt of any investigational drugs not affectingdiabetes within 30 days prior to screening for this study

  • 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 eGFR value of below 30 mL/min/1.73 m^2 according to CKDEPI creatinine equation as defined by KDIGO 2012 classification by the centrallaboratory at screening

  • In participants treated with SGLT2i, renal impairment measured as eGFR value ofbelow 60 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined byKDIGO 2012 classification by the central laboratory at screening

The following criteria apply to all participants:

Obesity-related:

  • Treatment with any medication indicated for weight management within 90 days priorto screening

  • Previous or planned (during the study period) obesity treatment with surgery or aweight loss device. However, the following are allowed: (1) liposuction and/orabdominoplasty, if performed greater than 1 year prior to screening, (2) lapbanding, if the band has been removed greater than 1 year prior to screening, (3)intragastric balloon, if the balloon has been removed greater than 1 year prior toscreening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removedgreater than 1 year prior to screening

  • Uncontrolled thyroid disease per investigators discretion

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysbefore screening irrespective of medical records

Study Design

Total Participants: 201
Treatment Group(s): 2
Primary Treatment: placebo (semaglutide)
Phase: 3
Study Start date:
November 16, 2021
Estimated Completion Date:
September 01, 2023

Connect with a study center

  • Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital

    Sapporo city, Hokkaido 004-0004
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Sapporo city, Hokkaido 004-0004
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yamato-shi, Kanagawa 242-0004
    Japan

    Site Not Available

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa 242-0004
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • Naka Kinen Clinic

    Ibaraki, 311-0113
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Ibaraki, 311-0113
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Minato-ku, Tokyo, 105-8470
    Japan

    Site Not Available

  • Toranomon Hospital, Endocrinology and Metabolism

    Minato-ku, Tokyo, 105-8470
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Osaka, 569-1045
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Site Not Available

  • Takatsuki Red Cross Hospital

    Osaka, 569-1045
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Sapporo City, Hokkaido, 004-0004
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Suita-shi, Osaka, 565-0853
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 160-0008
    Japan

    Site Not Available

  • ToCROM Clinic

    Tokyo, 160-0008
    Japan

    Site Not Available

  • Tokyo Center Clinic

    Tokyo, 103-0028
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yamato-shi, Kanagawa, 242-0004
    Japan

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Novo Nordisk Investigational Site

    Seoul, 03181
    Korea, Republic of

    Site Not Available

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