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Can a new weekly shot beat semaglutide for diabetes control?

NCT ID NCT06649344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This phase 3 trial compares an experimental once-weekly injection, HRS9531, to the established drug semaglutide in adults with type 2 diabetes that is not well controlled by metformin alone or with SGLT2 inhibitors. The study will measure changes in blood sugar levels and body weight over 36 and 52 weeks. The goal is to see if HRS9531 offers better glucose control and weight management than semaglutide.

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 once-weekly injection called HRS9531
What this could lead to
If HRS9531 outperforms semaglutide, it could offer a new, more effective option for managing type 2 diabetes and supporting weight loss.
What could go wrong
This is an early-phase 3 trial, so results may not confirm superiority. Side effects typical of this drug class, such as nausea or gastrointestinal issues, are possible.

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

884 people

The number who actually took part.

Started

Oct 2024

Finished

Jul 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. Diagnosed with type 2 diabetes ≥ 90 days； 2. Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors; 3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%; 4. Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding. Exclusion Criteria: 1. Known or suspected allergy or intolerance to the investigational medicinal products or related products； 2. Acute complications of diabetes occurred during the previous 6 months； 3. Serious chronic complications of diabetes in the past； 4. Use other antidiabetic drugs for ≥3months prior to screening ; 5. Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery; 6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening; 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

Contacts and locations

Locations

  • Zhu Xianyi Memorial Hospital,Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000, China

More trials for these conditions

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