A Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Obesity

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Participants With Obesity

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: HRS-4729 Injection Placebo; Drug: HRS-4729 Injection; Drug: HRS-4729 Injection; Drug: HRS-4729 Injection; Drug: HRS-4729 Injection;; Drug: HRS-4729 Injection;; Drug: HRS-4729 Injection

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ziwei Du; Phone Number: +86 0518-81220121; Email: ziwei.du.zd9@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
      • Principal Investigator: Weiqing Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Male or female adults aged 18 to 65 years.
3. BMI: 28.0 to 40.0 kg/m2.
4. Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.

Exclusion Criteria:

1. Endocrine disease or history that may have a significant effect on body weight;
2. History of diabetes mellitus (gestational diabetes excepted);
3. Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;
4. Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;
5. Known or suspected excessive alcohol use, or a history of alcohol, drug, or substance abuse;
6. Acute or chronic hepatitis, or a history of severe hepatic disease other than metabolic dysfunction-associated fatty liver disease;
7. Prior or planned organ or bone marrow transplantation during the study period;
8. Any hematologic disorder that may interfere with the determination of HbA1c;
9. An autoimmune disease for which systemic corticosteroid or immunosuppressive therapy is planned during the study period;
10. Use of any medication or treatment likely to cause clinically significant weight gain or weight loss within 3 months prior to screening;
11. Participation in any clinical trial of an investigational drug or medical device within 3 months prior to screening;
12. Blood donation or blood loss ≥400 mL, or receipt of a blood transfusion, within 3 months prior to screening;
13. Mental incapacity or language impairment sufficient to preclude adequate understanding of, or participation in, the trial procedures;
14. Investigators, site staff, or other personnel directly involved in conduct of the study, and their immediate family members; employees of the Sponsor;
15. Any condition that, in the investigator's judgment, would compromise participant safety or otherwise interfere with the assessment of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1; Drug: HRS-4729 Injection	Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 1; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 2; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 3
Experimental: Dose 2; Drug: HRS-4729 Injection	Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 1; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 2; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 3
Experimental: Dose 3; Drug: HRS-4729 Injection	Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 1; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 2; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 3
Experimental: Dose 4; Drug: HRS-4729 Injection	Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 4; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 5; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 6
Experimental: Dose 5; Drug: HRS-4729 Injection	Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 4; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 5; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 6
Experimental: Dose 6; Drug: HRS-4729 Injection	Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 4; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 5; Drug: HRS-4729 Injection; HRS-4729 Injection; Dose 6
Placebo Comparator: Placebo; Drug: HRS-4729 Injection Placebo	Drug: HRS-4729 Injection Placebo; HRS-4729 Injection Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Body Weight	Baseline, Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Body Weight	Baseline, Week 40
Change From Baseline in Body Weight	Baseline, Week 32 and 40
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 32 and 40
Change from Baseline in Waist Circumference	Baseline, Week 32 and 40
Change from Baseline in Blood Pressure	Baseline, Week 32 and 40
Change from Baseline in Glucose Level	Baseline, Week 32 and 40
TEAEs	Baseline, Week 44

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HRS-4729-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No