JRCT ID: jRCT2011210053
Registered date:26/11/2021
Efficacy and safety of oral semaglutide 50 mg once daily in East Asian participants with overweight or obesity (NN9932-4738, OASIS 2)
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Obesity |
Date of first enrollment | 16/11/2021 |
Target sample size | 158 |
Countries of recruitment | South Korea,Japan |
Study type | Interventional |
Intervention(s) | 1. To take oral semaglutide 50 mg once daily or placebo once daily as an adjunct to reduced-calorie diet and increased physical activity 2. The trial comprises a screening period followed by a treatment period and a follow up period. The treatment period is divided into a dose escalation period of 16 weeks and a maintenance period of 52 weeks 3. To perform assessments specified in the protocol |
Outcome(s)
Primary Outcome | Primary endpoints: 1. Ralative change in body weight from baseline to end-of-treatment (%-point) 2. Achievement of body weight reduction >=5% (Yes/No) at end-of-treatment (count of subjects) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Male or female, age >=18 years at the time of signing informed consent 2. Body mass index (BMI) of.>=27.0 kg/m2 with>= 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI >=35.0 kg/m2 with >=1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or T2D 3. History of at least one self-reported unsuccessful dietary effort to lose body weight For participants with T2D at screening 4. Diagnosed with T2D >= 180 days prior to screening 5. Treated with either diet and exercise alone or stable treatment (same drug(s), 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, Alpha-glucosidase inhibitor (AGI), sulphonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i)) or thiazolidinediones) 6. HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening |
Exclude criteria | For participants without T2D 1. HbA1c >=6.5% (48 mmol/mol) as measured by the central laboratory at screening 2. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records For participants with T2D at screening 3. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening For all participants 4. Treatment with any medication indicated for weight management within 90 days prior to screening 5. History of major depressive disorder within 2 years prior to screening 6. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) |
Related Information
Primary Sponsor | Hirose Ryoma |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | U1111-1258-7561 |
Contact
Public contact | |
Name | Ryoma Hirose |
Address | 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005 |
Telephone | +81-362661000 |
JPHC_clinical_trials@novonordisk.com | |
Affiliation | Novo Nordisk Pharma Ltd. |
Scientific contact | |
Name | Ryoma Hirose |
Address | 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005 |
Telephone | +81-362661000 |
JPHC_clinical_trials@novonordisk.com | |
Affiliation | Novo Nordisk Pharma Ltd. |