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New pill HRS-7535 aims to tame type 2 diabetes

NCT ID NCT06672172

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This completed phase 3 trial tested three doses of the oral drug HRS-7535 against a placebo in 284 adults with type 2 diabetes whose blood sugar was not well controlled by diet and exercise alone. The main goal was to see if HRS-7535 could lower HbA1c (a measure of average blood sugar) over 32 weeks. Researchers also tracked weight changes and how many participants reached target blood sugar levels.

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 tablet (a drug to lower blood sugar)
What this could lead to
If successful, HRS-7535 could offer a new oral medication option to help control blood sugar and possibly reduce weight in people with type 2 diabetes.
What could go wrong
This is a completed phase 3 trial, but results are not yet public. The drug may not prove significantly better than placebo, and side effects are possible. It is not a cure and requires ongoing use.

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

284 people

The number who actually took part.

Started

Sep 2024

Finished

Apr 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 2 months before the screening visit; 3. HbA1c 7.0-10.0% (both inclusive) at screening; 4. Treated with diet and exercise, and without any antidiabetic drugs 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

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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