semaglutide 50 mg
DrugParticipants will have semaglutide for 68 weeks and will have 1 tablet every morning.
Dose gradually increased to 50 mg.
NCT Number: NCT05132088
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital, Sapporo, Hokkaido, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply:
For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-4:
Exclusion criteria
Participants without T2D only:
Participants with T2D at screening only:
The following criteria apply to all participants:
Obesity-related:
Participants will have semaglutide for 68 weeks and will have 1 tablet every morning.
Dose gradually increased to 50 mg.
Participants will have placebo tablets for 68 weeks and will have 1 tablet every morning.
Time frame: From baseline (week 0) to end of treatment (week 68)
Percentage-point
Time frame: At end of treatment (week 68)
Count of participants
Time frame: At end of treatment (week 68)
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 68)
Score points
Time frame: At end of treatment (week 68)
Count of participants
Time frame: At end of treatment (week 68)
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 68)
Count of participants
Time frame: From baseline (week 0) to end of treatment (week 68)
Messured in CM
Time frame: From baseline to end of treatment (week 68)
%-point
Time frame: From baseline to end of treatment (week 68)
Messured in cm^2
Time frame: From baseline (week 0) to end of treatment (week 68)
Messured in mmHg
Time frame: From randomisation (week 0) to end of treatment (week 68)
Messured in mmHg
Time frame: From baseline (week 0) to end of treatment (week 68)
%-point
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline
Time frame: From baseline (week 0) to end of study (week 75)
Count of events
Time frame: From baseline (week 0) to end of study (week 75)
Count of events
Novo Nordisk A/S
Industry
Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity
Acronym: OASIS 2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02075710
Body Weight, Nutrition Disorders
San Francisco, California, United States
View Trial DetailsNCT07717814
Body Weight, Nutrition Disorders
Anaheim, California, United States
View Trial DetailsNCT07313761
Body Weight, Nutrition Disorders
Anaheim, California, United States
View Trial DetailsNCT05330247
Body Weight, Diabetes Mellitus
Copenhagen, Copenhagen NV, Denmark
View Trial Details