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New diabetes combo pill shows promise in Late-Stage trial

NCT ID NCT05814393

Disease control Sponsor: JW Pharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tested whether adding an experimental drug called JW0201 to standard diabetes medications (metformin and empagliflozin) helps lower blood sugar more effectively. The study involved 200 adults with type 2 diabetes whose blood sugar was not well controlled on their current treatment. Participants took either JW0201 or a placebo for 24 weeks, and researchers measured changes in HbA1c, a key blood sugar marker.

What this could mean

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

Active substance
JW0201 (an experimental drug added to metformin and empagliflozin)
What this could lead to
If successful, JW0201 could offer a new add-on option to help people with type 2 diabetes achieve better blood sugar control when standard medications are not enough.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo, and side effects are possible. It is not a cure and requires ongoing medication.

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

200 people

The number who actually took part.

Started

Jan 2023

Finished

Nov 2024

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

19 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: * Type 2 Diabetes Mellitus Exclusion Criteria: * Type 1 Diabetes Mellitus * The subject not meet the specified HbA1c and FPG

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Kangbuk Samsung Hospital

    Seoul, South Korea

More trials for these conditions

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