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Drug combo shows promise for weight loss in severe obesity

NCT ID NCT03968224

Disease control Sponsor: Centro Medico Nacional Siglo XXI IMSS Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding dapagliflozin to metformin helps people with prediabetes or type 2 diabetes and severe obesity lose more weight than metformin alone. About 160 participants took either both drugs or just metformin for up to 12 months. The main goal was to see if the combination leads to at least 10% more weight loss. The study also checked changes in blood pressure and waist size.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

160 people

The number who actually took part.

Started

Aug 2018

Finished

Jul 2024

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

18 to 60 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: * BMI greater than or equal to 40 kg/m\^2 * Diagnosis of diabetes or prediabetes according to the criteria of the ADA * Patients who sign informed consent letter Exclusion Criteria: * Use of insulin or sulfonylureas * Chronic renal failure with glomerular filtration rate \<60 ml/min/1.73 m\^2 * Use of loop diuretics with no possibility to suspend * Active genitourinary tract infections determined by symptomatology or urinalysis * Use of drugs for weight control * Patients with untreated or uncontrolled hypothyroidism

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Conditions

The condition(s) this trial relates to.

morbid obesity prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2 Obesity, morbid Prediabetes

Contacts and locations

Locations

  • Hospital de Especialidades Centro Médico Nacional Siglo XXI

    Mexico City, 06720, Mexico

More trials for these conditions

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