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Type 2 DiabetesPhase 1NCT06246175

A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects

A Phase 1 study testing HRS9531 in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess how fast HRS9531 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
HRS9531
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
28 Feb 2024to 2 Sep 2025
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
  • Age 18-65 years on the date of signing informed consent (inclusive);
  • Body mass index (BMI) within the range of 19.0-40.0 kg/m2 (inclusive);
  • Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
  • Normal renal function: 90-129 mL/min (inclusive);
  • Mild impairment: 60-89 mL/min (inclusive);
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  • Moderate impairment: 30-59 mL/min (inclusive);
  • Severe impairment: 15-29 mL/min (inclusive);
  • Females of childbearing potential should have negative baseline blood pregnancy test, and must use highly effective contraception from signing the informed consent form to 2 months after the last dose of trial drug; Male subjects must agree to either remain abstinent or use highly effective contraceptive measures during the trial and 2 months after last dose of the trial drug, or have been surgically sterilized;
  • Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
  • Diagnosed as stable, chronic renal disease for at least 3 months.

Who cannot join

  • Have any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy);
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;
  • Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
  • Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
  • Blood donation history or blood loss ≥400 mL within 3 month or ≥200 mL within 1 month before screening, or received blood transfusion within 3 months;
  • Allergic constitution includes severe drug allergy or history of drug allergy;
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  • Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications;
  • Have an average weekly alcohol intake that exceeds 14 units per week or average daily cigarettes consumption exceeds 5 per day, and are unwilling to stop alcohol or cigarettes consumption 24 hours prior to dosing until discharge from the study or completion of all study procedures (1 unit =12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits);
  • History use of GLP-1R（glucagon-like peptide-1 receptor） agonist, GLP-1R/GCGR（glucagon receptor）agonist, GIPR（glucose-dependent insulinotropic polypeptide receptor/GLP-1R agonist or GIPR/GLP-1R/GCGR agonist within 2 months prior to screening;
  • Breast-feeding women;
  • The use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1), unless deemed acceptable by the investigator;
  • History of Vasovagal Syncope; Do not have venous access sufficient to allow blood sampling as per the protocol；
  • The need to follow a special diet and unable to follow the diet requirement of protocol;
  • The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study
  • Healthy Participants:
  • Systolic blood pressure <90 mmHg or ≥140 mmHg; Diastolic blood pressure <50 mmHg 或≥90 mmHg; Heart Rate < 50 beats/min or >100 beats/min;
  • Have a significant history or presence of cardiovascular (eg, myocardial infarction, cerebrovascular accident, etc. within the past 6 months), respiratory, hepatic, renal, GI, endocrine (except T2DM), haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data;
  • Use of medications determined to be unsuitable by the investigator (including over-the-counter medication, prescription medication and herbal preparations) within the 14 days prior to screening;
  • Have clinical laboratory test results outside normal reference range for the population or investigator site and judged to be clinically significant by the investigator;
  • Participants with Renal Impairment：
  • Systolic blood pressure <90 mmHg or≥160 mmHg; Diastolic blood pressure <50 mmHg 或 ≥100 mmHg; Heart Rate < 50 beats/min or >100 beats/min;
  • Have a significant history or presence of cardiovascular (eg, myocardial infarction, cerebrovascular accident, decompensated heart failure (NYHA classification III or IV), etc. within the past 6 months), respiratory, hepatic, renal (obstructive urinary tract disease, except CKD), GI, endocrine (except T2DM), haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data;
  • History of Kidney Transplant;
  • Subjects started new over-the-counter or prescription medications (eg, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions or on their treatment regimen for less than 1 month;
  • Have following clinically relevant abnormal laboratory test results:
  • Hemoglobin <85 grams per liter (g/L);
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× the upper limit of normal (ULN) or total bilirubin (TBL) >1.5× ULN;
  • Serum triglyceride > 5.64 mmol/L（500 mg/dl）;
  • Clinical relevant elevation in serum amylase or lipase；
  • QTcF > 450 msec;
  • Other abnormal lab results, as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chengdu Xinhua Hospital

    Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of HRS9531injection in Healthy Subjects and Subjects With Impaired Renal Function

The purpose of this study is to assess how fast HRS9531 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Conditions
Type 2 Diabetes
Being tested
HRS9531
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.

  • HRS9531Drug

    Receive a single dose of HRS9531 injection

Study groups in NCT06246175
Study groupRoleWhat they receive
A group (Healthy Control)ExperimentalNot described
Receives: Drug: HRS9531
B group (Mild Renal Impairment)ExperimentalNot described
Receives: Drug: HRS9531
C group (Moderate Renal Impairment)ExperimentalNot described
Receives: Drug: HRS9531
D group (Severe Renal Impairment)ExperimentalNot described
Receives: Drug: HRS9531

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to T(last) (AUC0-t)

    Measured: Start of Treatment up to Day 29

  2. Maximum Concentration of HRS9531 (Cmax)

    Measured: Start of Treatment up to Day 29

  3. Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to Infinity (AUC0-inf)

    Measured: Start of Treatment up to Day 29

Secondary outcomes (5)

  1. Time to maximum concentration (Tmax)

    Measured: Start of Treatment up to Day 29

  2. Apparent terminal half-life (t1/2)

    Measured: Start of Treatment up to Day 29

  3. Apparent clearance (CL/F)

    Measured: Start of Treatment up to Day 29

  4. Apparent volume of distribution (Vz/F)

    Measured: Start of Treatment up to Day 29

  5. Incidence and severity of adverse events

    Measured: Screening period up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start28 Feb 2024
  3. Primary completion2 Sep 2025
  4. Study completion2 Sep 2025

Resources

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
Model description
This study is a single-dose, parallel design trial.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06246175
Sponsor's protocol ID
HRS9531-105
Status last verified
Apr 2026
First submitted
30 Jan 2024
Last updated
5 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS9531 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 11 inclusion and 32 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 May 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?

Area Under the Concentration Versus Time Curve (AUC) of HRS9531 From Time Zero to T(last) (AUC0-t) (time frame: Start of Treatment up to Day 29). 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?

On the ClinicalTrials.gov record for NCT06246175.

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 May 2026.

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