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Daily pill could offer new hope for weight loss in east asian adults

NCT ID NCT05132088

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

201 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2023

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113, Japan

  • OCROM Clinic_Internal medicine

    Suita-shi, Osaka, 565-0853, Japan

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Shinsapporo Seiryou Hospital_General Clinical Department

    Sapporo, Hokkaido, 004-0004, Japan

  • Takatsuki Red Cross Hospital

    Osaka, 569-1045, Japan

  • Takatsuki Red Cross Hospital_Diabetes and Endocrine Div.

    Osaka, 569-1045, Japan

  • The University of Osaka Hospital_Metabolic Medicine

    Osaka, 565-0871, Japan

  • ToCROM Clinic_Internal Medicine

    Tokyo, 160-0008, Japan

  • Tokyo Center Clinic

    Tokyo, 103-0028, Japan

  • Tokyo Center Clinic_Internal Medicine

    Tokyo, 103-0028, Japan

  • Toranomon Hospital, Endocrinology and Metabolism

    Minato-ku, Tokyo, 105-8470, Japan

  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

    Yamato-shi, Kanagawa, 242-0004, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.