Type 2 DiabetesPhase 2NCT05759897
A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
A Phase 2 study testing HRS-7535 in people with Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd..
Trial summary
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus. 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
- 180 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2023to 4 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-75 age years, both inclusive;
- Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);
Who cannot join
- Known or suspected allergy to the investigational drug or its components or excipients.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
- Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
- History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
- Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons.
- Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy).
- Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A 16-week Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.
- 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 HRS-7535 administered orally Receives: Drug: HRS-7535 |
| Group B | Experimental | Subjects will receive HRS-7535 administered orally Receives: Drug: HRS-7535 |
| Group C | Experimental | Subjects will receive escalated dose of HRS-7535 administered orally Receives: Drug: HRS-7535 |
| Group D | Experimental | Subjects will receive escalated HRS-7535 administered orally Receives: Drug: HRS-7535 |
| Group E | 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.
Mean Change From Baseline in HbA1c at Week 16
Measured: at Week 16]
Secondary outcomes (8)
Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16
Measured: at Week 16
Change From Baseline in fasting plasma glucose (FPG) at Week 16
Measured: at Week 16
Change From Baseline in Mixed meal test at Week 16
Measured: at Week 16
Change From Baseline in body weight at Week 16
Measured: at Week 16
Change From Baseline in waist circumference at Week 16
Measured: at Week 16
Change From Baseline in 7-point SMBG at Week 16
Measured: at Week 16
Proportion of subjects receiving glycemic rescue medicine at Week 16
Measured: at Week 16
A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[
Measured: at Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start28 Feb 2023 (estimated)
- Primary completion21 Dec 2023 (estimated)
- Study completion4 Jan 2024 (estimated)
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
- Model description
- HRS-7535 tablet compared with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
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
- NCT05759897
- Sponsor's protocol ID
- HRS-7535-201
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guo L, Sun Z, Zhang L, Qin G, Li Y, Chen X, Xu N, Su X, Mao L, Sun J, Cheng Z, Shi X, Wang F, Wang Q, Pan R, Ding S, Ye Z, Xu Y, Liu P. HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2615622. doi: 10.1001/jamanetworkopen.2026.15622.
PubMed 42234428
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
- ClinicalTrials.gov ID
- NCT05759897
- Acronym / sponsor ID
- HRS-7535-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 21 Dec 2023 (estimated)
- Study completion
- 4 Jan 2024 (estimated)
- First posted
- 8 Mar 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.
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- HRS-7535 tablet compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS-7535Subjects will receive HRS-7535 administered orally |
| Group B | Experimental | Drug: HRS-7535Subjects will receive HRS-7535 administered orally |
| Group C | Experimental | Drug: HRS-7535Subjects will receive escalated dose of HRS-7535 administered orally |
| Group D | Experimental | Drug: HRS-7535Subjects will receive escalated HRS-7535 administered orally |
| Group E | 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 (5 listed)
- Male or female, 18-75 age years, both inclusive;
- Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);
Key exclusion criteria (8 listed)
- Known or suspected allergy to the investigational drug or its components or excipients.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
- Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
- History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
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, Group C, Group D |
| PlaceboPlacebo | Drug | Group E |
Primary outcome
Mean Change From Baseline in HbA1c at Week 16
Time frame: at Week 16]
8 secondary outcomes
Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16
Time frame: at Week 16
Change From Baseline in fasting plasma glucose (FPG) at Week 16
Time frame: at Week 16
Change From Baseline in Mixed meal test at Week 16
Time frame: at Week 16
Change From Baseline in body weight at Week 16
Time frame: at Week 16
Change From Baseline in waist circumference at Week 16
Time frame: at Week 16
Change From Baseline in 7-point SMBG at Week 16
Time frame: at Week 16
Proportion of subjects receiving glycemic rescue medicine at Week 16
Time frame: at Week 16
A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[
Time frame: at Week 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 42234428Guo L, Sun Z, Zhang L, Qin G, Li Y, Chen X, Xu N, Su X, Mao L, Sun J, Cheng Z, Shi X, Wang F, Wang Q, Pan R, Ding S, Ye Z, Xu Y, Liu P. HRS-7535 for Type 2 Diabetes Inadequately Controlled With Metformin: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2615622. doi: 10.1001/jamanetworkopen.2026.15622.
- 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.
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..
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 8 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yimei Xu (0518-82342973, yimei.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in HbA1c at Week 16 (time frame: at 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 NCT05759897, 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 8 Mar 2023.