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New diabetes drug QLG1091 takes on rybelsus in Head-to-Head trial

NCT ID NCT07487103

Disease control Sponsor: Qilu Pharmaceutical Co., Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a new oral diabetes medication, QLG1091, to the existing drug Rybelsus, both taken alongside metformin. About 478 adults with type 2 diabetes will take one of the two pills daily for 26 weeks. The goal is to see if QLG1091 controls blood sugar (HbA1c) as well as Rybelsus.

What this could mean

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

Active substance
QLG1091 (a new oral diabetes drug)
What this could lead to
If successful, QLG1091 could offer a new, effective oral option for managing type 2 diabetes alongside metformin.
What could go wrong
This is an early-stage comparison study, not a cure. The new drug may not be as effective or safe as Rybelsus, and results may not apply to all patients.

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

About 478 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

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 to 75 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: 1. Female or male，age 18 to 75. 2. Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening. 3. HbA1c of 7.0-10.5 %. 4. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening. 5. Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg/day) at least 90 days prior to the day of screening. Exclusion Criteria: 1. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma. 2. History of pancreatitis (acute or chronic). 3. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). 4. Subjects presently classified as being in New York Heart Association Class IV. 5. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 6. Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).

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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

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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