T2DMPhase 2NCT07599410
A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus
A Phase 2 study testing HRS9531 Tablet in people with T2DM, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- T2DM
- What is being tested?
- HRS9531 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jul 2026to Jul 2027
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 70 years on the day of signing the informed consent form;
- Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);
- HbA1c between 7.5% and 10.5% at screening;
- Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;
- Fasting plasma glucose ≤ 15 mmol/L;
- Body mass index (BMI) between 20.0 kg/m² and 40.0 kg/m² at screening;
- Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures and potential adverse reactions, and be able and willing to comply with protocol requirements to complete the study;
- Have no fertility plans from the signing of the informed consent form until 2 months after the last dose, and agree to use highly effective contraceptive measures as specified in the protocol.methods.
Who cannot join
- Participants with relevant abnormal test results at screening.
- Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.
- Participants with poorly controlled blood pressure.
- Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.
- Participants who experienced acute diabetic complications within 6 months prior to screening.
- Participants who experienced severe hypoglycemic events or recurrent hypoglycemic events within 6 months prior to screening.
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- Participants with severe chronic diabetic complications at screening, or non-proliferative diabetic retinopathy requiring treatment during the trial.
- Participants with a past or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- Participants with a past or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatment requiring gallbladder disease.
- Participants with a past history of significant gastrointestinal diseases (such as severe diabetic gastroparesis, gastric outlet obstruction, inflammatory bowel disease, active ulcer, etc.), or who have undergone gastrointestinal surgery (excluding gastrointestinal polypectomy and appendectomy), or who are taking long-term medications that directly affect gastrointestinal motility.
- Participants with a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening.
- Participants with known or suspected depression, bipolar disorder, suicidal ideation, schizophrenia, or other severe psychiatric disorders; or participants who are mentally incompetent, have language barriers, are unable to fully understand the trial protocol, or are unwilling to cooperate with study site staff.
- Participants with a history of malignant tumor within 5 years prior to screening, except for cured localized cancers such as localized basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Any other conditions that, in the investigator's judgment, render the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Guang Wang
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xinguo Hou
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.
The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.
- Conditions
- T2DM
- Being tested
- HRS9531 Tablet, HRS9531 Tablet placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 TabletDrug
HRS9531 Tablet dose 1
HRS9531 TabletDrug
HRS9531 Tablet dose 2
HRS9531 TabletDrug
HRS9531 Tablet dose 3
HRS9531 TabletDrug
HRS9531 Tablet dose 4
HRS9531 TabletDrug
HRS9531 Tablet dose 5
HRS9531 Tablet placeboDrug
HRS9531 Tablet placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: HRS9531 Tablet | Experimental | Not described Receives: Drug: HRS9531 Tablet |
| Treatment group B: HRS9531 Tablet | Experimental | Not described Receives: Drug: HRS9531 Tablet |
| Treatment group C: HRS9531 Tablet | Experimental | Not described Receives: Drug: HRS9531 Tablet |
| Treatment group D: HRS9531 Tablet | Experimental | Not described Receives: Drug: HRS9531 Tablet |
| Treatment group E: HRS9531 Tablet | Experimental | Not described Receives: Drug: HRS9531 Tablet |
| Treatment group F:Placebo | Placebo comparator | Not described Receives: Drug: HRS9531 Tablet placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c) relative to baseline
Measured: Week 20.
Secondary outcomes (5)
Percentage of participants achieving HbA1c < 7.0%
Measured: Week 20
Percentage change in fasting body weight relative to baseline
Measured: Week 20
Change in fasting plasma glucose (FPG) relative to baseline
Measured: Week 20
Incidence of hypoglycemic events across all groups
Measured: Week 20
Incidence of adverse events (AEs) across all groups
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start14 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 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
- NCT07599410
- Sponsor's protocol ID
- HRS9531-T-202
- Status last verified
- Jul 2026
- First submitted
- 11 May 2026
- Last updated
- 23 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT07599410
- Acronym / sponsor ID
- HRS9531-T-202
- Conditions
- T2DM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 May 2026 (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 aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: HRS9531 Tablet | Experimental | Drug: HRS9531 Tablet |
| Treatment group B: HRS9531 Tablet | Experimental | Drug: HRS9531 Tablet |
| Treatment group C: HRS9531 Tablet | Experimental | Drug: HRS9531 Tablet |
| Treatment group D: HRS9531 Tablet | Experimental | Drug: HRS9531 Tablet |
| Treatment group E: HRS9531 Tablet | Experimental | Drug: HRS9531 Tablet |
| Treatment group F:Placebo | Placebo comparator | Drug: HRS9531 Tablet placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged 18 to 70 years on the day of signing the informed consent form;
- Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);
- HbA1c between 7.5% and 10.5% at screening;
- Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;
- Fasting plasma glucose ≤ 15 mmol/L;
Key exclusion criteria (15 listed)
- Participants with relevant abnormal test results at screening.
- Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.
- Participants with poorly controlled blood pressure.
- Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.
- Participants who experienced acute diabetic complications within 6 months prior to screening.
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 TabletHRS9531 Tablet dose 1 | Drug | Treatment group A: HRS9531 Tablet |
| HRS9531 TabletHRS9531 Tablet dose 2 | Drug | Treatment group B: HRS9531 Tablet |
| HRS9531 TabletHRS9531 Tablet dose 3 | Drug | Treatment group C: HRS9531 Tablet |
| HRS9531 TabletHRS9531 Tablet dose 4 | Drug | Treatment group D: HRS9531 Tablet |
| HRS9531 TabletHRS9531 Tablet dose 5 | Drug | Treatment group E: HRS9531 Tablet |
| HRS9531 Tablet placeboHRS9531 Tablet placebo | Drug | Treatment group F:Placebo |
Primary outcome
Change in glycated hemoglobin (HbA1c) relative to baseline
Time frame: Week 20.
5 secondary outcomes
Percentage of participants achieving HbA1c < 7.0%
Time frame: Week 20
Percentage change in fasting body weight relative to baseline
Time frame: Week 20
Change in fasting plasma glucose (FPG) relative to baseline
Time frame: Week 20
Incidence of hypoglycemic events across all groups
Time frame: Week 20
Incidence of adverse events (AEs) across all groups
Time frame: Week 20
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 23 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS9531 Tablet in people with T2DM, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 2 sites 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 8 inclusion and 15 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 23 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 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Junmeng Shi (17721288226, junmeng.shi.js12@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin (HbA1c) relative to baseline (time frame: Week 20.). 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 23 Jul 2026.