Diabetes Mellitus, Type 2Phase 3NCT06650007
the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone
A Phase 3 study testing HRS9531 Injection in people with Diabetes Mellitus, Type 2, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 36 weeks of treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HRS9531 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2024to 12 Jun 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
- Males and females, Age ≥18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
- Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
- 7.5% ≤ HbA1c ≤10.0% at screening.
Who cannot join
- Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- 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.).
- 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) ；
- Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410100
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone
The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 36 weeks of treatment
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HRS9531 Injection, HRS9531 Placebo 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 Injection
HRS9531 Placebo InjectionDrug
HRS9531 Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: HRS9531 Injection |
| Group B | Placebo comparator | Not described Receives: Drug: HRS9531 Placebo Injection |
| Group C | Experimental | Not described Receives: Drug: HRS9531 Injection |
| Group D | Placebo comparator | Not described Receives: Drug: HRS9531 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: from baseline to 36 weeks treatment
Secondary outcomes (4)
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Measured: from baseline to 36 weeks treatment
Change in FPG
Measured: from baseline to 36 weeks treatment
Change in body weight
Measured: from baseline to 36 weeks treatment
Proportion of subjects with HbA1c<7.0% and weight loss ≥5%
Measured: from baseline to 36 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start8 Nov 2024
- Primary completion21 Jan 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 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
- NCT06650007
- Sponsor's protocol ID
- HRS9531-302
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2024
- Last updated
- 14 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone
- ClinicalTrials.gov ID
- NCT06650007
- Acronym / sponsor ID
- HRS9531-302
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 21 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 primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 36 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS9531 Injection |
| Group B | Placebo comparator | Drug: HRS9531 Placebo Injection |
| Group C | Experimental | Drug: HRS9531 Injection |
| Group D | Placebo comparator | Drug: HRS9531 Placebo Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, Age ≥18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
- Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
- 7.5% ≤ HbA1c ≤10.0% at screening.
Key exclusion criteria (6 listed)
- Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- 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.).
- 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) ；
- Severe infection, severe trauma, or moderate-to-major surgery within 1 month before 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 InjectionHRS9531 Injection | Drug | Group A, Group C |
| HRS9531 Placebo InjectionHRS9531 Placebo Injection | Drug | Group B, Group D |
Primary outcome
Change in HbA1c
Time frame: from baseline to 36 weeks treatment
4 secondary outcomes
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Time frame: from baseline to 36 weeks treatment
Change in FPG
Time frame: from baseline to 36 weeks treatment
Change in body weight
Time frame: from baseline to 36 weeks treatment
Proportion of subjects with HbA1c<7.0% and weight loss ≥5%
Time frame: from baseline to 36 weeks treatment
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 14 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 in people with Diabetes Mellitus, Type 2, 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 6 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 14 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. 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?
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: from baseline to 36 weeks treatment). 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 14 Jul 2026.