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

NCT07690826 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-4729-202
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Weight

  Baseline, Week 32

Secondary Outcomes (7)

• 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

Study Arms (7)

Dose 1

EXPERIMENTAL

Drug: HRS-4729 Injection

Drug: HRS-4729 Injection

Dose 2

EXPERIMENTAL

Drug: HRS-4729 Injection

Drug: HRS-4729 Injection

Dose 3

EXPERIMENTAL

Drug: HRS-4729 Injection

Drug: HRS-4729 Injection

Dose 4

EXPERIMENTAL

Drug: HRS-4729 Injection

Drug: HRS-4729 Injection;

Dose 5

EXPERIMENTAL

Drug: HRS-4729 Injection

Drug: HRS-4729 Injection;

Dose 6

EXPERIMENTAL

Drug: HRS-4729 Injection

Drug: HRS-4729 Injection;

Placebo

PLACEBO COMPARATOR

Drug: HRS-4729 Injection Placebo

Drug: HRS-4729 Injection Placebo

Interventions

HRS-4729 Injection; DRUG

HRS-4729 Injection; Dose 4

Dose 4

HRS-4729 Injection Placebo DRUG

HRS-4729 Injection Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent.
• Male or female adults aged 18 to 65 years.
• BMI: 28.0 to 40.0 kg/m2.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ziwei Du

CONTACT

+86 0518-81220121; ziwei.du.zd9@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

CN (1)