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Overweight/ObesityPhase 1NCT07807059

A Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment

A Phase 1 study testing HRS-4729 in people with Overweight/Obesity and Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8 healthy participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
HRS-4729
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
9 Sep 2026to 15 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Provide written informed consent prior to any study-related procedures, and have a full understanding of the study content, procedures, and potential adverse events.
  • Be aged 18 to 65 years (inclusive), of either sex.
  • Have a body mass index (BMI) between 19 and 40 kg/m² (inclusive).
  • Glomerular filtration rate (absolute eGFR) must meet the relevant requirements and criteria specified in the protocol.
  • Have stable renal function.
  • Women of childbearing potential must have been using reliable contraception and have a negative serum pregnancy test at baseline, and must be willing to use highly effective contraceptive measures from the time of signing informed consent until 2 months after the last dose of study drug. Male Participants must be willing not to plan to father a child during the trial and until 2 months after the last dose, and voluntarily take effective contraceptive measures, or have undergone surgical sterilization.
  • Healthy participants: demographic means at screening must match those of the renal impairment groups as follows:
  • Body weight matched within ±10 kg of the group mean; Age matched within ±10 years of the group mean; Sex ratio matched within ±1 subject. 8.For participants in the renal impairment groups: Participants must have a diagnosis of chronic (>3 months) and stable (no acute deterioration of renal function within 1 month prior to screening) renal impairment.

Who cannot join

  • Have a history of significant abnormal gastric emptying, severe gastrointestinal disease, or gastrointestinal surgery (except gastrointestinal polypectomy), as assessed by the investigator to be unsuitable for participation.
  • Have a history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), or a history of pancreatitis or symptomatic cholelithiasis.
  • Have a history of malignancy in any organ system within the past 5 years, regardless of evidence of local recurrence or metastasis, with the exception of cured localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the prostate.
  • Have undergone any surgery within 6 months prior to dosing, or plan to undergo surgery during the study period (excluding gastrointestinal polypectomy).
  • Have participated in any clinical trial of a drug or medical device within 3 months prior to dosing. Participation in a clinical trial is defined as having signed informed consent and having used the investigational product (including placebo) or investigational medical device; or are still within the follow-up period of another clinical study or within 5 half-lives of the investigational drug (whichever is longer).
  • Have had blood loss or blood donation of ≥400 mL within 3 months prior to dosing, or ≥200 mL within 1 month prior to dosing, or have received a blood transfusion within 3 months prior to dosing.
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  • Have a known history of severe drug allergy or drug hypersensitivity;
  • Test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus (HIV) antibody, or positive for rapid plasma reagin (RPR) test or toluidine red unheated serum test (TRUST) for syphilis.
  • Have a history of drug abuse or substance abuse within 1 year prior to dosing, or test positive on urine multi-drug screening.
  • Are habitual smokers or drinkers and are unable to abstain during the trial; or have a positive alcohol breath test.
  • Have used receptor agonists or inhibitors related to the investigational drug within 2 months prior to screening; Participants who discontinued the above agents due to intolerance more than 2 months prior to screening should also be excluded.
  • Are pregnant or lactating women at the time of screening and baseline visits.
  • Have consumed foods or beverages containing methylxanthines (e.g., tea, coffee, cola, chocolate, energy drinks) or alcohol within 48 hours prior to the first dose of study drug; or have engaged in strenuous exercise within that period.
  • Have a history of needle phobia, syncope with blood or needles, difficulty in blood collection, or intolerance to venipuncture.
  • Have special dietary habits that, in the investigator's opinion, make them unsuitable for participation, or are unable to comply with the dietary requirements during the trial.
  • Have any other condition that, in the investigator's opinion, makes the subject unsuitable for the study, or withdraw voluntarily for personal reasons.
  • For healthy participants:
  • 1）At screening, have systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <50 mmHg or ≥90 mmHg, or heart rate <50 bpm or >100 bpm. 2）Have a history of significant diseases involving the cardiovascular, hepatic, renal, digestive, psychiatric/neurological, endocrine, respiratory, hematological, or immune systems prior to screening. Have used any medication (including over-the-counter drugs, herbal medicines, and dietary supplements) that, in the investigator's judgment, may affect the study results, within 14 days or 5 half-lives (whichever is longer) prior to dosing. 3）Have clinically significant abnormalities in physical examination, vital signs, laboratory tests (hematology, biochemistry, urinalysis, coagulation, etc.), or 12-lead electrocardiogram (including QTcF) at screening.
  • 18.For participants with renal impairment:
  • Have poorly controlled blood pressure despite pharmacological intervention at screening: systolic blood pressure <90 mmHg or ≥160 mmHg, diastolic blood pressure <50 mmHg or ≥100 mmHg, or heart rate <50 bpm or >100 bpm.
  • Have obstructive uropathy (e.g., urinary stones, urinary obstruction due to abdominal space-occupying lesions) and/or diseases that may cause renal damage (e.g., renal artery stenosis, acute drug-induced injury, severe infection, hypovolemia).
  • Have a history of severe disease involving the cardiovascular (except for well-controlled hypertension within the past month), respiratory, hepatic, gastrointestinal, endocrine (except for hyperlipidemia, hyperuricemia, and diabetes with stable blood glucose within the past month), hematological, or psychiatric/neurological systems within 1 year prior to screening, as assessed by the investigator to be unsuitable for participation; or have a prior diagnosis of decompensated heart failure (NYHA Class III or IV).
  • Have undergone renal transplantation.
  • Have not been on a stable regimen of therapeutic medications for their renal disease and/or other comorbidities for at least 1 month prior to screening, or have had any new medication added within 1 month prior to screening (excluding temporary or intermittent medications, such as erythropoietin administered once monthly or as-needed diuretics); or have received any drug known to affect renal tubular secretion of creatinine (e.g., cimetidine, trimethoprim, or cibenzoline) within 14 days or 5 half-lives (whichever is longer) prior to dosing.
  • Have any of the following abnormalities in laboratory tests (hematology, biochemistry, urinalysis, coagulation, etc.) or 12-lead ECG at screening:
  • Hemoglobin <85 g/L;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× upper limit of normal (ULN), and total bilirubin (TBIL) ≥1.5× ULN;
  • Fasting triglycerides (TG) >5.64 mmol/L (500 mg/dL);
  • Clinically significant abnormalities in serum amylase or lipase;
  • QTcF (Fridericia-corrected) >450 msec in males or >470 msec in females;
  • Any other laboratory abnormality that, in the investigator's opinion, may affect subject safety.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ziwei Du contact

0518-82342973

ziwei.du.zd9@hengrui.com

China1 site, 1 recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Mengchang Yang

    Recruiting

Other trials in China

About this study

Official title: An Open-Label, Parallel-Group, Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment

This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8 healthy participants.

Being tested
HRS-4729
Medical subject headings
Overweight, Obesity, Fatty Liver, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-4729Drug

    Each subject will receive a single subcutaneous dose of HRS-4729 injection solution.

Study groups in NCT07807059
Study groupRoleWhat they receive
Group A: control group, comprising healthy Participants with normal renal function;ExperimentalNot described
Receives: Drug: HRS-4729
Group B: comprise Participants with mild renal impairment;ExperimentalNot described
Receives: Drug: HRS-4729
Group C: comprise Participants with moderate renal impairment;ExperimentalNot described
Receives: Drug: HRS-4729
Group D: comprise Participants with severe renal impairment;ExperimentalNot described
Receives: Drug: HRS-4729

What is being measured

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

  1. Cmax

    Measured: assessed up to approximately 4 weeks post-dose;

  2. AUC0-t

    Measured: assessed up to approximately 4 weeks post-dose

  3. AUC0-inf.

    Measured: assessed up to approximately 4 weeks post-dose

Secondary outcomes (10)

  1. Tmax

    Measured: assessed up to approximately 4 weeks post-dose

  2. CL/F

    Measured: assessed up to approximately 4 weeks post-dose

  3. Vz/F

    Measured: assessed up to approximately 4 weeks post-dose

  4. t1/2

    Measured: assessed up to approximately 4 weeks post-dose

  5. Blood pressure

    Measured: assessed up to approximately 4 weeks post-dose

  6. Pulse

    Measured: assessed up to approximately 4 weeks post-dose;

  7. Body temperature

    Measured: assessed up to approximately 4 weeks post-dose

  8. physical examination

    including measurements of height in meters, weight in kilograms. Also, a complete physical examination was performed, including inspection, palpation, percussion, and auscultation of all relevant systems (general appearance, skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal system, and neurological system).

    Measured: assessed up to approximately 4 weeks post-dose

  9. 12-lead electrocardiogram (ECG)

    including heart rate, QT interval, QTcF interval, and PR interval

    Measured: assessed up to approximately 4 weeks post-dose

  10. Immunogenicity assessment: anti-HRS-4729 antibodies

    Measured: assessed up to approximately 4 weeks post-dose

Timeline

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

  1. First posted8 Sep 2026
  2. Study start9 Sep 2026
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

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
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807059
Sponsor's protocol ID
HRS-4729-102
Status last verified
Sep 2026
First submitted
17 Aug 2026
Last updated
16 Sep 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 HRS-4729 in people with Overweight/Obesity and Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), 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 8 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 16 Sep 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ziwei Du (0518-82342973, ziwei.du.zd9@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: assessed up to approximately 4 weeks post-dose;). 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 NCT07807059.

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 16 Sep 2026.

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