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Could a Low-Calorie diet and Weight-Loss drug send type 2 diabetes into remission?

NCT ID NCT07753447

Disease control Sponsor: Yeouido St. Mary's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether a 12-week calorie-restricted diet, combined with the weight-management drug Contrave, can help people with type 2 diabetes and obesity achieve remission. Remission means blood sugar levels drop below the diabetes threshold without needing glucose-lowering medications. The study enrolls adults under 60 who have had diabetes for less than six years and a BMI of 27 or higher. Participants will receive either the dietary intervention with Contrave or a control, and researchers will compare remission rates and weight changes.

What this could mean

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

Active substance
A combination of a low-calorie meal plan and an extended-release medication called Contrave (naltrexone and bupropion) to reduce appetite and support weight loss.
What this could lead to
If successful, this approach could offer a non-surgical path to diabetes remission for people with obesity, potentially reducing or eliminating the need for diabetes medications.
What could go wrong
The trial is small (25 participants) and short (12 weeks), so results may not be generalizable. Remission may not be durable, and the medication can have side effects like nausea, headache, or increased blood pressure.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

25 people

The number who actually took part.

Started

Jul 2025

Finished

Feb 2026

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

19 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: * Adults aged ≥19 and \<60 years * Confirmed diagnosis of type 2 diabetes * Diagnosed with diabetes within the past 6 years * Most recent BMI within the past 3 months ≥27 kg/m² * Most recent HbA1c within the past 3 months \<11% * No insulin therapy within the past 3 months Exclusion Criteria: * Pregnant women or those who may become pregnant during the study period * Individuals with organ failure, such as heart failure, hepatic failure, renal failure, or chronic obstructive pulmonary disease * History of cardiovascular disease or cancer treatment within the past 6 months * Acute illness requiring hospitalization (e.g., infection or surgery) within the past 3 months * Presence of endocrine disorders that may affect body weight, such as Cushing's syndrome * Use of medications (other than glucose-lowering agents for diabetes) known to affect blood glucose levels within the past 6 months * Individuals with known food allergies to specific ingredients in the study meals * Individuals with uncontrolled hypertension * Individuals with acute alcohol or drug withdrawal symptoms * History of seizure disorders such as epilepsy * Individuals with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes type 2 Obesity &amp; overweight

Contacts and locations

Locations

  • Yeouido Saint Mary's Hospital

    Seoul, 07345, South Korea

More trials for these conditions

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