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Completed

NCT Number: NCT06250946

Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Medical Center of Chinese People's Liberation Army (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

  • Male or female subjects, 18-65 years of age at the time of signing informed consent;
  • At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
  • Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
  • Able and willing to provide a written informed consent

Exclusion criteria

  • Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
  • Uncontrollable hypertension;
  • PHQ-9 score ≥15;
  • History of diabetes;
  • History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
  • Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
  • Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
  • Use of any medication or treatment that may have caused significant weight change within 2 months;
  • History of bariatric surgery;
  • history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
  • Surgery is planned during the trial;
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
  • Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Treatment and study plan

HRS-7535;Placebo

Drug

HRS-7535;Placebo

Placebo

Drug

Placebo

Primary outcomes

  1. Percent change in body weight from baseline at Week 26

    Time frame: Week 26

Secondary outcomes

  1. Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  2. Percent change in body weight from baseline at Week 36

    Time frame: Week 36

  3. Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  4. Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  5. Change from baseline in fasting plasma glucoseat Week 26 and Week 36

    Time frame: Week 26 and Week 36

  6. Change from baseline in fasting serum insulin at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  7. Change from baseline in HbA1c at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  8. Change from baseline in total cholesterol (TC) at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  9. Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36

    Time frame: Week 26 and Week 36

  10. Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3

    Time frame: Week 26 and Week 3

  11. Change from baseline in triglycerides (TG) at Week 26 and Week 36

    Time frame: Week 26 and Week 36

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2024
Registry last updated
Apr 13, 2025

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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