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New injectable drug aims to tame blood sugar in type 2 diabetes

NCT ID NCT06650007

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether an experimental injectable drug called HRS9531 can help adults with type 2 diabetes achieve better blood sugar control when diet and exercise alone are not enough. Participants receive either HRS9531 or a placebo for 36 weeks. The main goal is to see if the drug lowers HbA1c, a key measure of long-term blood sugar, and also to check for weight loss and safety.

What this could mean

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

Active substance
an experimental injectable drug called HRS9531
What this could lead to
If successful, HRS9531 could offer a new treatment option for people with type 2 diabetes to better control blood sugar and possibly lose weight.
What could go wrong
This is a mid-stage trial with 218 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful benefit over placebo.

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

218 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 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 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. Males and females, Age ≥18 years at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening. 3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening. 4. 7.5% ≤ HbA1c ≤10.0% at screening. Exclusion Criteria: 1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.). 4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ； 5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening. 6. Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2

Contacts and locations

Locations

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410100, China

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