Daily pill could offer new hope for weight loss in east asian adults
NCT ID NCT05132088
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This Phase 3 trial is testing whether a once-daily 50 mg semaglutide tablet can help East Asian adults with overweight or obesity lose weight. Participants will take either the active tablet or a placebo for 68 weeks, alongside lifestyle counseling on diet and physical activity. The study measures changes in body weight and the proportion of people achieving at least 5% weight loss.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide 50 mg oral tablet
- What this could lead to
- If successful, this could provide a convenient daily pill option for weight management in East Asian adults with overweight or obesity.
- What could go wrong
- The trial is still testing the drug's efficacy and safety; results may not apply to all populations, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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201 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Sep 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female, age above or equal to 18 years at the time of signing informed consent * Body mass index (BMI) of greater than or equal to 27.0 kg/m\^2 with greater than or equal to 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI greater than or equal to 35.0 kg/m\^2 with greater than or equal to1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2 diabetes (T2D) * History of at least one self-reported unsuccessful dietary effort to lose body weight For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1-4: * Diagnosed with T2D greater than or equal to 180 days prior to screening * 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 (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or thiazolidinediones) * HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening Exclusion criteria: Participants without T2D only: * HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes * Treatment with glucose-lowering agent(s) within 90 days prior to screening * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR brlow 15 ml/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO) 2012 classification by the central laboratory at screening Participants with T2D at screening only: * Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening * Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this study, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this study * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Renal impairment measured as eGFR value of below 30 mL/min/1.73 m\^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening * In participants treated with SGLT2i, renal impairment measured as eGFR value of below 60 mL/min/1.73 m\^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening The following criteria apply to all participants: Obesity-related: * Treatment with any medication indicated for weight management within 90 days prior to screening * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening, (2) lap banding, if the band has been removed greater than 1 year prior to screening, (3) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year prior to screening * Uncontrolled thyroid disease per investigators discretion * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Gachon University Gil Medical Center
Incheon, 21565, South Korea
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Kangbuk Samsung Hospital
Seoul, 03181, South Korea
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Kyungpook National University Hospital
Daegu, 41944, South Korea
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Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
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OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853, Japan
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
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Shinsapporo Seiryou Hospital_General Clinical Department
Sapporo, Hokkaido, 004-0004, Japan
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Takatsuki Red Cross Hospital
Osaka, 569-1045, Japan
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Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.
Osaka, 569-1045, Japan
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The University of Osaka Hospital_Metabolic Medicine
Osaka, 565-0871, Japan
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ToCROM Clinic_Internal Medicine
Tokyo, 160-0008, Japan
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Tokyo Center Clinic
Tokyo, 103-0028, Japan
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Tokyo Center Clinic_Internal Medicine
Tokyo, 103-0028, Japan
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Toranomon Hospital, Endocrinology and Metabolism
Minato-ku, Tokyo, 105-8470, Japan
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Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004, Japan
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