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

NCT07807059 | Recruiting Phase 1

• 1 other identifier: HRS-4729-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight/Obesity; Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH); Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Cmax

  assessed up to approximately 4 weeks post-dose;

• AUC0-t

  assessed up to approximately 4 weeks post-dose

• AUC0-inf.

  assessed up to approximately 4 weeks post-dose

Secondary Outcomes (10)

• Tmax

  assessed up to approximately 4 weeks post-dose

• CL/F

  assessed up to approximately 4 weeks post-dose

• Vz/F

  assessed up to approximately 4 weeks post-dose

• t1/2

  assessed up to approximately 4 weeks post-dose

• Blood pressure

  assessed up to approximately 4 weeks post-dose

Study Arms (4)

Group A: control group, comprising healthy Participants with normal renal function;

EXPERIMENTAL

Drug: HRS-4729

Group B: comprise Participants with mild renal impairment;

EXPERIMENTAL

Drug: HRS-4729

Group C: comprise Participants with moderate renal impairment;

EXPERIMENTAL

Drug: HRS-4729

Group D: comprise Participants with severe renal impairment;

EXPERIMENTAL

Drug: HRS-4729

Interventions

HRS-4729 DRUG

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

Group A: control group, comprising healthy Participants with normal renal function;; Group B: comprise Participants with mild renal impairment;; Group C: comprise Participants with moderate renal impairment;; Group D: comprise Participants with severe renal impairment;

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Fatty Liver; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ziwei Du

CONTACT

0518-82342973; ziwei.du.zd9@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 8, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

CN (1)