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Not yet recruiting NCT07690826

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

Phase II Interventional Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-4729 Injection, HRS-4729 Injection, HRS-4729 Injection, HRS-4729 Injection;.
Who it may be relevant to
Registry conditions: Overweight or Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • 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
  • Drug HRS-4729 Injection Placebo
    HRS-4729 Injection Placebo

Primary outcome measures

  • Percent Change From Baseline in Body Weight [Time frame: Baseline, Week 32]
Secondary outcome measures (7)
  • Percent Change From Baseline in Body Weight [Time frame: Baseline, Week 40]
  • Change From Baseline in Body Weight [Time frame: Baseline, Week 32 and 40]
  • Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 32 and 40]
  • Change from Baseline in Waist Circumference [Time frame: Baseline, Week 32 and 40]
  • Change from Baseline in Blood Pressure [Time frame: Baseline, Week 32 and 40]
  • Change from Baseline in Glucose Level [Time frame: Baseline, Week 32 and 40]
  • TEAEs [Time frame: Baseline, Week 44]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07690826 · HRS-4729-202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗