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New pill HRS-7535 takes on diabetes in Head-to-Head trial

NCT ID NCT06589765

Disease control Sponsor: Shandong Suncadia Medicine 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study compares a new drug, HRS-7535, to an existing diabetes medication, dapagliflozin, in adults with type 2 diabetes whose blood sugar is not well controlled with metformin alone. The goal is to see if HRS-7535 works better at lowering blood sugar and body weight over 32 weeks. About 810 participants will take either HRS-7535 or dapagliflozin, without knowing which they receive.

What this could mean

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

Active substance
HRS-7535
What this could lead to
If successful, HRS-7535 could offer a new oral option for better blood sugar control and weight loss in type 2 diabetes.
What could go wrong
This is an early-phase comparison; HRS-7535 may not prove superior to dapagliflozin, and side effects are still being evaluated.

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

810 people

The number who actually took part.

Started

Sep 2024

Finished

May 2026

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. Male or female, 18-75 age years, both inclusive; 2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 3. HbA1c 7.5-11.0% (both inclusive) at screening; 4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening. Exclusion Criteria: 1. Known or suspected allergy to the investigational drug or its components or excipients. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening. 4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

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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

Contacts and locations

Locations

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

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