Evaluating HRS-7535 Tablets for Overweight and Obesity

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity

This study is testing if HRS-7535 tablets can help people who are overweight or obese lose weight safely and effectively.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06904105 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of HRS-7535 tablets in individuals who are overweight or obese. Participants aged 18 to 75 with a Body Mass Index (BMI) of 28 or higher, or 24 or higher with weight-related comorbidities, will be enrolled. The study will involve a comparison between HRS-7535 and placebo tablets, with participants required to maintain a stable weight and follow a controlled diet and exercise regimen for three months prior to the trial. The trial is designed to gather data on the treatment's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a BMI of 28 or higher, or 24 or higher with associated weight-related health issues.

Not a fit: Patients with significant abnormal laboratory test results or ECG findings at screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for managing overweight and obesity, potentially improving health outcomes for patients.

How similar studies have performed: While there have been various studies on obesity treatments, the specific approach with HRS-7535 is novel and has not been extensively tested in prior trials.

Eligibility criteria

Inclusion Criteria:

1. On the day of signing the informed consent form, the age should be between 18 and 75 years old.
2. At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
3. The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
4. Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.

Exclusion Criteria:

1. At the screening period, relevant laboratory test results are abnormal.
2. Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
3. Uncontrolled severe hypertension at the screening period.
4. Presence of endocrine diseases that may significantly affect the body weight.
5. History of acute or chronic pancreatitis.
6. History of significant gastrointestinal diseases.
7. Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
8. Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
9. Known or suspected abuse of alcohol or narcotics.
10. Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.

Where this trial is running

Beijing, Beijing

• Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yicen Zong

Conditions Overweight; Obesity