Efficacy and safety of oral semaglutide 50 mg once daily in East Asian participants with overweight or obesity (NN9932-4738, OASIS 2)

Phase 3

• Conditions: Obesity

• Registration Number: JPRN-jRCT2011210053
• Lead Sponsor: Hirose Ryoma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 158

Inclusion 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

Exclusion 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified