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New diabetes drug HRS-7535 shows promise in early trial

NCT ID NCT06393348

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial tested a new drug called HRS-7535 in 155 adults with type 2 diabetes whose blood sugar was not well controlled despite taking metformin and an SGLT2i. Participants received either HRS-7535 or a placebo for 16 weeks. The main goal was to see if the drug could lower HbA1c (a measure of average blood sugar) more than placebo.

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 it works, this could offer a new oral medication option to help people with type 2 diabetes better control their blood sugar and possibly lose weight.
What could go wrong
This is an early Phase 2 trial with only 155 people, so results may not apply to everyone. The drug may not prove effective or could have side effects not yet seen.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

155 people

The number who actually took part.

Started

May 2024

Finished

Mar 2025

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 subjects, 18-75 years of age at the time of signing informed consent; 2. Have T2DM (based on the 2020 Chinese Diabetes Society \[CDS\] diagnostic criteria) 3. HbA1c为7.5%≤HbA1c≤11.0% at the screening visit； 4. FPG≤15 mmol/L at the screening visit; 5. Have been treated with an SGLT2i with metformin, for at least 8 weeks; 6. At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2; 7. Able and willing to provide a written informed consent Exclusion Criteria: 1. Have type 1 diabetesmellitus; 2. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 3. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 4. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 5. Surgery is planned during the trial; 6. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

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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

  • The Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangdong, Guangzhou, 51020, China

More trials for these conditions

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