To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Last updated: July 10, 2025
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Obesity

Hypertriglyceridemia

Treatment

HRS9531 injection

Placebo

Clinical Study ID

NCT06396429
HRS9531-301
  • Ages > 18
  • All Genders

Study Summary

The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide a written informed consent.

  2. Male or female subjects, ≥18 years of age at the time of signing informed consent.

  3. At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-relatedcomplication, such as prediabetes, hypertension, dyslipidemia, obstructive sleepapnea, and nonalcoholic fatty liver disease.

  4. Diet and exercise control for at least 3 months before screening visit, and lessthan 5 kg self-reported change within the last 3 months.

  5. Fertile male and female subjects (including partners) have no plans to have childrenand agree to use effective contraception within 2 months after signing the informedconsent form and the last medication, and fertile female or male subjects have noplans to donate eggs/sperm; Fertile female subjects tested negative for regnancywithin the first 3 days of randomization and were not lactating.

Exclusion

Exclusion Criteria:

  1. Presence of clinically significant lab results at screening visit;

  2. Uncontrollable hypertension;

  3. PHQ-9 score ≥15;

  4. Medical history or illness that affects your weight;

  5. History of diabetes;

  6. Acute infection, acute trauma, or medium to large surgery within 1 month prior toscreening;

  7. History of acute cardiovascular and cerebrovascular diseases within 6 months priorto screening;

  8. Any organ-system malignancies developed within 5 years except for cured local basalcell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of theprostate;

  9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies,schizophrenia, or other serious mental illness;

  10. Known or suspected history of alcohol and/or substance abuse or drug abuse;

  11. History of acute or chronic hepatitis or other serious liver disease other thanalcoholic fatty liver disease.

  12. Have received or plan to have an organ or bone marrow transplant during the study.

  13. The presence of any blood disorders that may interfere with HbA1c testing.

  14. Autoimmune disease is present and systemic glucocorticoid therapy orimmunosuppressive therapy is planned during the study.

  15. Use of drugs or treatments that may have caused significant weight gain or losswithin the 3 months prior to screening;

  16. Weight loss surgery or endoscopic and/or medical device-based weight loss therapy isplanned for or during the study period;

  17. Use of drugs or treatments that may have caused significant weight gain or losswithin the 3 months prior to screening;

  18. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusionwithin 3 months before screening.

  19. Surgery is planned during the tria;

  20. Mentally incapacitated or speech-impaired subjects are unable to fully understand orparticipate in the test process;

  21. In the investigator's judgment, there are circumstances (medical, psychological,social, or geographical factors, etc.) that affect subject safety or any otherconditions that interfere with the evaluation of the test results.

Study Design

Total Participants: 567
Treatment Group(s): 2
Primary Treatment: HRS9531 injection
Phase: 3
Study Start date:
May 13, 2024
Estimated Completion Date:
July 07, 2025

Connect with a study center

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

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