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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Shinsapporo Seiryou Hospital_General Clinical Department, 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: Baseline (week 0), week 68
Percent change in body weight from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Time frame: At week 68
Number of participants who achieved >=5% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Time frame: At week 68
Number of participants who achieved >=10% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Time frame: Baseline (week 0), week 68
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patient's quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results for Physical Function Domain are presented in this outcome measure. The outcome measure was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Time frame: At week 68
Number of participants who achieved >=15% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction. The outcome measure was evaluated based on in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: At week 68
Number of participants who achieved >=20% weight reduction at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction. The outcome measure was evaluated based on in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in BMI from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in waist circumference measured according to JASSO guideline from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in VFA measured by CT Scan in a subset of the japanese study population from baseline (week 0) to week 68 is presented in %. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in VFA measured by CT Scan in a subset of the japanese study population from baseline (week 0) to week 68 is presented in cm^2. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site (week 75).
Time frame: Baseline (week 0), week 68
Change in hsCRP measured as milligrams per liter (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Time frame: Week 0 to week 75
An adverse event (AE) defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment: the date of first trial product administration (week 0) to the date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days. For the evaluation of adverse events the lag time for each on-treatment time interval is 7 weeks.
Time frame: Week 0 to week 75
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the date of first trial product administration (week 0) to the date of last trial product administration (week 68) excluding potential off-treatment time intervals of more than 3 consecutive days. For the evaluation of adverse events the lag time for each on-treatment time interval is 7 weeks.
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.
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