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NCT Number: NCT07690826

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location contact

Weiqing Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS-4729 Injection

Drug

HRS-4729 Injection; Dose 1

HRS-4729 Injection;

Drug

HRS-4729 Injection; Dose 4

HRS-4729 Injection Placebo

Drug

HRS-4729 Injection Placebo

Primary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 32

Secondary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline, Week 40

  2. Change From Baseline in Body Weight

    Time frame: Baseline, Week 32 and 40

  3. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 32 and 40

  4. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 32 and 40

  5. Change from Baseline in Blood Pressure

    Time frame: Baseline, Week 32 and 40

  6. Change from Baseline in Glucose Level

    Time frame: Baseline, Week 32 and 40

  7. TEAEs

    Time frame: Baseline, Week 44

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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