NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedObesity
Date of first enrollment16/11/2021
Target sample size158
Countries of recruitmentSouth Korea,Japan
Study typeInterventional
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 OutcomePrimary 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)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteriaFor 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

Contact

Public contact
Name Ryoma Hirose
Address 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005
Telephone +81-362661000
E-mail 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
E-mail JPHC_clinical_trials@novonordisk.com
Affiliation Novo Nordisk Pharma Ltd.