Comparing HRS9531 and placebo for overweight or obese individuals

Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

This study is testing an injectable treatment called HRS9531 to see if it can help overweight or obese people lose weight and improve their health over 48 weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06396429 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of HRS9531, an injectable treatment, in individuals who are overweight or obese over a period of 48 weeks. Participants will receive either HRS9531 or a placebo while adhering to a controlled diet and exercise regimen. The study aims to determine if HRS9531 can lead to significant weight loss and improve weight-related health complications. Eligible participants must have a BMI of 28 or higher, or 24 or higher with associated health issues.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a BMI of 28 or higher, or 24 or higher with weight-related complications.

Not a fit: Patients who are not overweight or obese, or those with significant health issues that disqualify them from participation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for effective weight management in overweight and obese patients.

How similar studies have performed: Other studies have shown promising results with similar weight management interventions, suggesting potential for success in this approach.

Eligibility criteria

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-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
5. Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.

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 to screening;
7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of the prostate;
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 than alcoholic 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 or immunosuppressive therapy is planned during the study.
15. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
16. Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
17. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
18. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
19. Surgery is planned during the tria;
20. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate 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 other conditions that interfere with the evaluation of the test results.

Where this trial is running

Shanghai, Shanghai

• Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hong Chen

Conditions Overweight or Obesity