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Completed

NCT Number: NCT06904105

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • On the day of signing the informed consent form, the age should be between 18 and 75 years old.
  • 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.
  • 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%.
  • 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

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

Treatment and study plan

HRS-7535 tablets

Drug

HRS-7535 tablets.

HRS-7535 Placebo Tablets

Drug

HRS-7535 placebo tablets.

Primary outcomes

  1. Percentage change in body weight relative to the baseline

    Time frame: 44th week after administration.

  2. Proportion of participants with a body weight reduction of ≥ 5% relative to the baseline

    Time frame: 44th week after administration.

Secondary outcomes

  1. Proportion of participants with a body weight reduction of ≥10% and ≥15% relative to baseline

    Time frame: 44th week and 50th week after administration

  2. Change in waist circumference relative to baseline

    Time frame: 44th week and 50th week after administration

  3. Percentage change in body weight relative to baseline

    Time frame: 50th week after administration

  4. Proportion of participants with a body weight reduction of ≥5%

    Time frame: 50th week after administration

  5. Adverse events

    Time frame: The entire process of the trial, about 52 weeks.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Jul 27, 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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