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New diabetes drug HRS9531 aims to improve blood sugar control in phase 3 trial

NCT ID NCT07060456

Disease control Sponsor: Fujian Shengdi 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new drug called HRS9531 against a placebo in 300 people with type 2 diabetes whose blood sugar is not well controlled with basal insulin. The main goal is to see if HRS9531 lowers blood sugar levels (HbA1c) more effectively after 40 weeks. Participants must be on a stable insulin dose and may also take metformin or SGLT2 inhibitors.

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 300 people

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

Started

Jul 2025

Expected to finish

Mar 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 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: 1. Male or female, able and willing to provide a written informed consent 2. Diagnosed with type 2 diabetes ≥ 90 days； 3. On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days; 4. HbA1c was 7.5%\~11.0% (both inclusive); 5. Body Mass Index (BMI) ≥22 kg/m2 at screening. Exclusion Criteria: 1. A history of type 1 diabetes, specific diabetes, or secondary diabetes; 2. Have a history of severe hypoglycemia within t180 days prior to screening; 3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening； 4. Have a history of malignancy within 5 years; 5. Known or suspected allergy or intolerance to the investigational medicinal products or related products; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days; 7. Any conditions that the Investigator judges might not be suitable to participate in the trial.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Perking University Peoples' Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

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