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Can diet, exercise, and pills tame metabolic syndrome?

NCT ID NCT06271200

Disease control Sponsor: National Health Research Institutes, Taiwan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a strict lifestyle program—eating only during an 8-hour window, walking 10,000 steps daily, and cutting 500 calories—can help obese adults with metabolic syndrome lose weight and improve heart health. After 24 weeks, participants also receive either Rybelsus or Forxiga, two weight-loss medications, for another 26 weeks. The goal is to see if these approaches work together to reduce metabolic risks and sustain weight loss over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lifestyle intervention (time-restricted eating, walking, calorie reduction) and weight-loss medications (Rybelsus or Forxiga)
What this could lead to
If successful, this could show that combining lifestyle changes with medication helps obese adults with metabolic syndrome lose weight and reduce heart disease risk.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to everyone. The lifestyle program is demanding, and medications can have side effects like nausea or dehydration.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 65 years

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: * Men or women aged from ≥ 20 years to 65 years * BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition Exclusion Criteria: * History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis * Diagnosis of type 1 or type 2 diabetes and regular taking oral or injection hypoglycemic therapy * History of malignant tumors with active managements. * History of medullary thyroid carcinoma or diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2) * Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2) * History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of severe gastrointestinal diseases or gastrointestinal surgery in the past 6 months * History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity without regular managements. * History of hypersensitivity to semaglutide or any component of RYBELSUS®, or history of severe hypersensitivity reactions to Forxiga, such as anaphylaxis or angioedema. * Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician * Currently participating in weight loss programs or weight change in the past 3 months (\>5% current body weight) * Women who are pregnant or plan to become pregnant * Patients who cannot be followed for 3 years (due to a health situation or migration) * Patients who are unwilling or unable to give informed consent

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome Intermittent Fasting metabolic syndrome X Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes

    RECRUITING

    Zhunan, Miaoli County, 350, Taiwan

More trials for these conditions

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