Diabetes MellitusPhase 1NCT06961643
Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing HRS-7535 Tables in people with Diabetes Mellitus, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- HRS-7535 Tables
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2025to 22 Jan 2026
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
- Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
- At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold).
Who cannot join
- In the judgment of the investigator, may be allergic to the study drug or its components.
- Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
- Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
- History of drug or substance abuse, or a positive urine drug test at screening.
- Donated or lost ≥ 400 mL of blood within 3 months prior to screening.
- Individuals with a history of severe hypoglycemia.
- Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Provincial Infectious Disease Hospital
Zhengzhou, Henan, 450015
About this study
Official title: Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Conditions
- Diabetes Mellitus
- Being tested
- HRS-7535 Tables
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7535 TablesDrug
Oral HRS-7535 tables.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Subjects with mild hepatic impairment. Receives: Drug: HRS-7535 Tables |
| Treatment group B | Experimental | Subjects with moderate hepatic impairment. Receives: Drug: HRS-7535 Tables |
| Treatment group C | Experimental | Subjects with normal hepatic function. Receives: Drug: HRS-7535 Tables |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration of HRS-7535 (Cmax)
Measured: Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)
Measured: Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
Measured: Post-dose at day 1 to day 4.
Secondary outcomes (5)
Time to maximum plasma concentration (Tmax)
Measured: Post-dose at day 1 to day 4.
Terminal half-life (t1/2)
Measured: Post-dose at day 1 to day 4.
Apparent clearance (CL/F)
Measured: Post-dose at day 1 to day 4.
Apparent volume of distribution (Vz/F)
Measured: Post-dose at day 1 to day 4.
Adverse events (AEs)
Measured: Screening period up to Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 Jun 2025
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06961643
- Sponsor's protocol ID
- HRS-7535-109
- Status last verified
- Feb 2026
- First submitted
- 6 May 2025
- Last updated
- 2 Mar 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Mild and Moderate Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06961643
- Acronym / sponsor ID
- HRS-7535-109
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 8 May 2025 (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 study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HRS-7535 TablesSubjects with mild hepatic impairment. |
| Treatment group B | Experimental | Drug: HRS-7535 TablesSubjects with moderate hepatic impairment. |
| Treatment group C | Experimental | Drug: HRS-7535 TablesSubjects with normal hepatic function. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
- Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female.
- At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18~32 kg/m2 (including the threshold).
Key exclusion criteria (7 listed)
- In the judgment of the investigator, may be allergic to the study drug or its components.
- Smoking an average of more than 10 cigarettes per day within 3 months prior to screening.
- Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine.
- History of drug or substance abuse, or a positive urine drug test at screening.
- Donated or lost ≥ 400 mL of blood within 3 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 |
|---|---|---|
| HRS-7535 TablesOral HRS-7535 tables. | Drug | Treatment group A, Treatment group B, Treatment group C |
Primary outcome
The maximum plasma concentration of HRS-7535 (Cmax)
Time frame: Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: Post-dose at day 1 to day 4.
Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf)
Time frame: Post-dose at day 1 to day 4.
5 secondary outcomes
Time to maximum plasma concentration (Tmax)
Time frame: Post-dose at day 1 to day 4.
Terminal half-life (t1/2)
Time frame: Post-dose at day 1 to day 4.
Apparent clearance (CL/F)
Time frame: Post-dose at day 1 to day 4.
Apparent volume of distribution (Vz/F)
Time frame: Post-dose at day 1 to day 4.
Adverse events (AEs)
Time frame: Screening period up to Day 7.
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 2 Mar 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 1 study testing HRS-7535 Tables in people with Diabetes Mellitus, 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 3 inclusion and 7 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 2 Mar 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The maximum plasma concentration of HRS-7535 (Cmax) (time frame: Post-dose at day 1 to day 4.). The study lists 3 primary outcomes in all. 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 2 Mar 2026.