Type 2 DiabetesPhase 3NCT06649344
A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes
A Phase 3 study testing HRS9531 Injection and Semaglutide Injection in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HRS9531 Injection and Semaglutide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 884 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 18 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes ≥ 90 days；
- 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;
- Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
- 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.
Who cannot join
- Known or suspected allergy or intolerance to the investigational medicinal products or related products；
- Acute complications of diabetes occurred during the previous 6 months；
- Serious chronic complications of diabetes in the past；
- Use other antidiabetic drugs for ≥3months prior to screening ;
- Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery;
- 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;
- Any conditions that the Investigator judges might not be suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhu Xianyi Memorial Hospital,Tianjin Medical University
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS9531 Injection, Semaglutide Injection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 InjectionDrug
HRS9531 injected subcutaneously once weekly.
Semaglutide InjectionDrug
Semaglutide injected subcutaneously once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | HRS953-low dose Receives: Drug: HRS9531 Injection |
| Treatment group B | Experimental | HRS9531-high dose Receives: Drug: HRS9531 Injection |
| Treatment group C | Active comparator | Semaglutide-1mg Receives: Drug: Semaglutide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
Measured: Week 0 to Week 36
Secondary outcomes (7)
Change in body weight
Change from baseline in body weight after 36 weeks of treatment.
Measured: Week 0 to Week 36
Proportion of Subjects with HbA1c≤6.5%
Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.
Measured: Week 0 to Week 36
Proportion of Subjects with HbA1c<7%
Proportion of subjects with HbA1c<7% after 36 weeks of treatment.
Measured: Week 0 to Week 36
Change in FPG (fasting plasma glucose)
Change from baseline in FPG after 36 weeks of treatment.
Measured: Week 0 to Week 36
Change in FPG (fasting plasma glucose)
Change from baseline in FPG after 52 weeks of treatment.
Measured: Week 0 to Week 52
7-points SMPG profiles
Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime.
Measured: Week 0 to Week 36
Incidence and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator.
Measured: Week 0 to Week 52+4 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start31 Oct 2024
- Primary completion18 Jul 2026
- Study completion18 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649344
- Sponsor's protocol ID
- HRS9531-303
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors
- ClinicalTrials.gov ID
- NCT06649344
- Acronym / sponsor ID
- HRS9531-303
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 18 Jul 2026 (actual)
- Study completion
- 18 Jul 2026 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS9531 InjectionHRS953-low dose |
| Treatment group B | Experimental | Drug: HRS9531 InjectionHRS9531-high dose |
| Treatment group C | Active comparator | Drug: Semaglutide InjectionSemaglutide-1mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes ≥ 90 days；
- 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;
- Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
- 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.
Key exclusion criteria (7 listed)
- Known or suspected allergy or intolerance to the investigational medicinal products or related products；
- Acute complications of diabetes occurred during the previous 6 months；
- Serious chronic complications of diabetes in the past；
- Use other antidiabetic drugs for ≥3months prior to screening ;
- Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9531 InjectionHRS9531 injected subcutaneously once weekly. | Drug | Treatment group A, Treatment group B |
| Semaglutide InjectionSemaglutide injected subcutaneously once weekly. | Drug | Treatment group C |
Primary outcome
Change in HbA1c
Time frame: Week 0 to Week 36
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
7 secondary outcomes
Change in body weight
Time frame: Week 0 to Week 36
Proportion of Subjects with HbA1c≤6.5%
Time frame: Week 0 to Week 36
Proportion of Subjects with HbA1c<7%
Time frame: Week 0 to Week 36
Change in FPG (fasting plasma glucose)
Time frame: Week 0 to Week 36
Change in FPG (fasting plasma glucose)
Time frame: Week 0 to Week 52
7-points SMPG profiles
Time frame: Week 0 to Week 36
Incidence and severity of adverse events
Time frame: Week 0 to Week 52+4 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS9531 Injection and Semaglutide Injection in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Week 0 to Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.