Type 2 DiabetesPhase 3NCT07060456
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
A Phase 3 study testing HRS9531 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 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Male or female, able and willing to provide a written informed consent
- Diagnosed with type 2 diabetes ≥ 90 days；
- On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
- HbA1c was 7.5%~11.0% (both inclusive);
- Body Mass Index (BMI) ≥22 kg/m2 at screening.
Who cannot join
- A history of type 1 diabetes, specific diabetes, or secondary diabetes;
- Have a history of severe hypoglycemia within t180 days prior to screening;
- History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；
- Have a history of malignancy within 5 years;
- Known or suspected allergy or intolerance to the investigational medicinal products or related products;
- Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
- Any conditions that the Investigator judges might not be suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Perking University Peoples' Hospital
Beijing, Beijing Municipality, 100044
Linong JI
About this study
Official title: A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS9531, Placebo
- 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.
HRS9531Drug
HRS9531-low dose
HRS9531Drug
HRS9531-high dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS9531-low dose | Experimental | Not described Receives: Drug: HRS9531 |
| Treatment group B: HRS9531-high dose | Experimental | Not described Receives: Drug: HRS9531 |
| Treatment group C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c after 40 weeks of treatment.
Measured: from baseline to Week 40
Secondary outcomes (4)
Proportion of subjects reaching HbA1<7.0%
Proportion of subjects reaching HbA1<7.0% after 40 weeks of treatment.
Measured: from baseline to Week 40
Proportion of subjects reaching HbA1≤6.5%
Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.
Measured: from baseline to Week 40
Change in FPG
Change in FPG after 40 weeks of treatment.
Measured: from baseline to Week 40
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Change from baseline in DTSQs after 40 weeks of treatment.
Measured: From baseline to Week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start25 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
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
- NCT07060456
- Sponsor's protocol ID
- HRS9531-305
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2025
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
- ClinicalTrials.gov ID
- NCT07060456
- Acronym / sponsor ID
- HRS9531-305
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 11 Jul 2025 (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 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS9531-low dose | Experimental | Drug: HRS9531 |
| Treatment group B: HRS9531-high dose | Experimental | Drug: HRS9531 |
| Treatment group C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, able and willing to provide a written informed consent
- Diagnosed with type 2 diabetes ≥ 90 days；
- On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
- HbA1c was 7.5%~11.0% (both inclusive);
- Body Mass Index (BMI) ≥22 kg/m2 at screening.
Key exclusion criteria (7 listed)
- A history of type 1 diabetes, specific diabetes, or secondary diabetes;
- Have a history of severe hypoglycemia within t180 days prior to screening;
- History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；
- Have a history of malignancy within 5 years;
- Known or suspected allergy or intolerance to the investigational medicinal products or related products;
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 |
|---|---|---|
| HRS9531HRS9531-low dose | Drug | Treatment group A: HRS9531-low dose |
| HRS9531HRS9531-high dose | Drug | Treatment group B: HRS9531-high dose |
| PlaceboPlacebo | Drug | Treatment group C |
Primary outcome
Change in HbA1c
Time frame: from baseline to Week 40
Change in HbA1c after 40 weeks of treatment.
4 secondary outcomes
Proportion of subjects reaching HbA1<7.0%
Time frame: from baseline to Week 40
Proportion of subjects reaching HbA1≤6.5%
Time frame: from baseline to Week 40
Change in FPG
Time frame: from baseline to Week 40
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Time frame: From baseline to Week 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 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.
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 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 5 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: looking for participants now, as of the sponsor's last update on 2 Jan 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Chen (+86-0518-82342973, hong.chen@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: from baseline to Week 40). 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 2 Jan 2026.