Type 2 DiabetesPhase 2NCT06393348
Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
A Phase 2 study testing HRS-7535 in people with Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HRS-7535
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2024to 13 Mar 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18-75 years of age at the time of signing informed consent;
- Have T2DM (based on the 2020 Chinese Diabetes Society [CDS] diagnostic criteria)
- HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
- FPG≤15 mmol/L at the screening visit;
- Have been treated with an SGLT2i with metformin, for at least 8 weeks;
- At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;
- Able and willing to provide a written informed consent
Who cannot join
- Have type 1 diabetesmellitus;
- 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 cancer of the skin and in-situ cancer of the cervix;
- history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- Surgery is planned during the trial;
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
Trial locations and contacts
1 site in 1 country.
China1 site
The Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangdong, Guangzhou, 51020
About this study
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS-7535, 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.
HRS-7535Drug
HRS-7535
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally Receives: Drug: HRS-7535 |
| Group B | Experimental | Subjects will receive dose of HRS-7535 administered orally Receives: Drug: HRS-7535 |
| Group C | Placebo comparator | Subjects will receive Placebo administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline at Week 16
Measured: Week 16
Secondary outcomes (5)
Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks
Measured: 16 weeks
Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks
Measured: 16 weeks
The change in fasting blood glucose from baseline to 16 weeks
Measured: 16 weeks
The change in in body weight from baseline to 16 weeks
Measured: 16 weeks
The change in 7-point SMBG profile from baseline to 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start17 May 2024
- Primary completion15 Nov 2024
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393348
- Sponsor's protocol ID
- HRS-7535-205
- Status last verified
- Nov 2025
- First submitted
- 28 Apr 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu M, Song W, Lv F, Fu Y, Yang L, Bin X, Zhang X, Ye Z, Zhang D, Lin X, Dai W, Shu C, Yan L. Efficacy and safety of HRS-7535, a novel oral small-molecule glucagon-like peptide-1 receptor agonist, in participants with type 2 diabetes mellitus inadequately controlled by metformin and sodium-glucose co-transporter 2 inhibitors: a multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase II trial. Diabetologia. 2026 Oct 14. doi: 10.1007/s00125-026-06892-2. Online ahead of print.
PubMed 42875600
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.
- ClinicalTrials.gov ID
- NCT06393348
- Acronym / sponsor ID
- HRS-7535-205
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 1 May 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.
2 weeks screening period, 3 weeks run-in period, 16 weeks double-blind treatment period, to evaluate the Safety and Efficacy of HRS-7535 in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin and SGLT2i.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS-7535Subjects will receive escalated dose of HRS-7535 administered orally |
| Group B | Experimental | Drug: HRS-7535Subjects will receive dose of HRS-7535 administered orally |
| Group C | Placebo comparator | Drug: PlaceboSubjects will receive Placebo administered orally |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18-75 years of age at the time of signing informed consent;
- Have T2DM (based on the 2020 Chinese Diabetes Society [CDS] diagnostic criteria)
- HbA1c为7.5%≤HbA1c≤11.0% at the screening visit；
- FPG≤15 mmol/L at the screening visit;
- Have been treated with an SGLT2i with metformin, for at least 8 weeks;
Key exclusion criteria (6 listed)
- Have type 1 diabetesmellitus;
- 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 cancer of the skin and in-situ cancer of the cervix;
- history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
- Surgery is planned during the trial;
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 |
|---|---|---|
| HRS-7535HRS-7535 | Drug | Group A, Group B |
| PlaceboPlacebo | Drug | Group C |
Primary outcome
Change in HbA1c from baseline at Week 16
Time frame: Week 16
5 secondary outcomes
Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks
Time frame: 16 weeks
Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks
Time frame: 16 weeks
The change in fasting blood glucose from baseline to 16 weeks
Time frame: 16 weeks
The change in in body weight from baseline to 16 weeks
Time frame: 16 weeks
The change in 7-point SMBG profile from baseline to 16 weeks
Time frame: 16 weeks
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 5 Dec 2025.
- Derived from this study: PubMed 42875600Xu M, Song W, Lv F, Fu Y, Yang L, Bin X, Zhang X, Ye Z, Zhang D, Lin X, Dai W, Shu C, Yan L. Efficacy and safety of HRS-7535, a novel oral small-molecule glucagon-like peptide-1 receptor agonist, in participants with type 2 diabetes mellitus inadequately controlled by metformin and sodium-glucose co-transporter 2 inhibitors: a multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase II trial. Diabetologia. 2026 Oct 14. doi: 10.1007/s00125-026-06892-2. Online ahead of print.
- 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 HRS-7535 in people with Type 2 Diabetes, run by Shandong Suncadia Medicine 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 7 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 5 Dec 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 in HbA1c from baseline at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06393348, which also lists 1 linked publication.
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 5 Dec 2025.