Type 2 DiabetesPhase 2NCT05966272
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
A Phase 2 study testing HRS9531 injection in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- 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
- 199 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2023to 24 Sep 2024
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ,18-65 years of age, agreed and signed the informed consent
- Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- HbA1c 7.5-10.5% (both inclusive) at screening visit.
Who cannot join
- Presence of any clinically significant results in examination at screening visit.
- Uncontrollable hypertension.
- A history of type 1 diabetes, specific diabetes, or secondary diabetes.
- Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
- History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Show all 11Show fewer
- Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
- Surgery is planned during the trial.
- Mentally incapacitated or speech-impaired.
- Pregnant or lactating woman.
- In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS9531 injection, HRS9531 injection 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.
HRS9531 injectionDrug
single dose
HRS9531 injection PlaceboDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | HRS9531 injection dose level 1 Receives: Drug: HRS9531 injection |
| Treatment group B | Experimental | HRS9531 injection dose level 2 Receives: Drug: HRS9531 injection |
| Treatment group C | Experimental | HRS9531 injection dose level 3 Receives: Drug: HRS9531 injection |
| Treatment group D | Experimental | HRS9531 injection dose level 4 Receives: Drug: HRS9531 injection |
| Treatment group E | Placebo comparator | HRS9531 injection Placebo dose level 1 Receives: Drug: HRS9531 injection Placebo |
| Treatment group F | Placebo comparator | HRS9531 injection Placebo dose level 2 Receives: Drug: HRS9531 injection Placebo |
| Treatment group G | Placebo comparator | HRS9531 injection Placebo dose level 3 Receives: Drug: HRS9531 injection Placebo |
| Treatment group H | Placebo comparator | HRS9531 injection Placebo dose level 4 Receives: Drug: HRS9531 injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c after 20 weeks of treatment
Measured: Week 0 to Week 20
Secondary outcomes (9)
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
Measured: Week 0 to Week 20
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
Measured: Week 0 to Week 32
Change From Baseline in HbA1c after 32 weeks
Measured: Week 0 to Week 32
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
Measured: Week 0 to Week 20
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
Measured: Week 0 to Week 32
Change from baseline body Weight and waist circumference after 20 weeks of treatment
Measured: Week 0 to Week 20
Change from baseline in body Weight and waist circumference after 32 weeks of treatment
Measured: Week 0 to Week 32
Number of Participants With Anti-HRS9531 Antibody
Measured: Week 0 to Week 36
Number of AEs During the Trial
Measured: Week 0 to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start12 Aug 2023
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 199 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
- NCT05966272
- Sponsor's protocol ID
- HRS9531-202
- Status last verified
- May 2025
- First submitted
- 21 Jul 2023
- Last updated
- 7 May 2025
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
- ClinicalTrials.gov ID
- NCT05966272
- Acronym / sponsor ID
- HRS9531-202
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 28 Jul 2023 (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.
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS9531 injectionHRS9531 injection dose level 1 |
| Treatment group B | Experimental | Drug: HRS9531 injectionHRS9531 injection dose level 2 |
| Treatment group C | Experimental | Drug: HRS9531 injectionHRS9531 injection dose level 3 |
| Treatment group D | Experimental | Drug: HRS9531 injectionHRS9531 injection dose level 4 |
| Treatment group E | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo dose level 1 |
| Treatment group F | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo dose level 2 |
| Treatment group G | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo dose level 3 |
| Treatment group H | Placebo comparator | Drug: HRS9531 injection PlaceboHRS9531 injection Placebo dose level 4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects ,18-65 years of age, agreed and signed the informed consent
- Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- HbA1c 7.5-10.5% (both inclusive) at screening visit.
Key exclusion criteria (11 listed)
- Presence of any clinically significant results in examination at screening visit.
- Uncontrollable hypertension.
- A history of type 1 diabetes, specific diabetes, or secondary diabetes.
- Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
- History of acute cardiovascular and cerebrovascular diseases 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 injectionsingle dose | Drug | Treatment group A, Treatment group B, Treatment group C, Treatment group D |
| HRS9531 injection Placebosingle dose | Drug | Treatment group E, Treatment group F, Treatment group G, Treatment group H |
Primary outcome
Change From Baseline in HbA1c after 20 weeks of treatment
Time frame: Week 0 to Week 20
9 secondary outcomes
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
Time frame: Week 0 to Week 20
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
Time frame: Week 0 to Week 32
Change From Baseline in HbA1c after 32 weeks
Time frame: Week 0 to Week 32
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
Time frame: Week 0 to Week 20
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
Time frame: Week 0 to Week 32
Change from baseline body Weight and waist circumference after 20 weeks of treatment
Time frame: Week 0 to Week 20
Change from baseline in body Weight and waist circumference after 32 weeks of treatment
Time frame: Week 0 to Week 32
Number of Participants With Anti-HRS9531 Antibody
Time frame: Week 0 to Week 36
Number of AEs During the Trial
Time frame: Week 0 to Week 36
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 7 May 2025.
- 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 2 study testing HRS9531 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 11 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 7 May 2025. 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 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?
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 From Baseline in HbA1c after 20 weeks of treatment (time frame: Week 0 to 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 7 May 2025.