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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06250946
• Other study ID #: HRS-7535-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: Yicen Zong
• Phone: 0518-82342973
• Email: yicen.zong[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects, 18-65 years of age at the time of signing informed consent;

2. At screening and random visit, 28.0 =BMI= 40.0 kg/m2;

3. 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.

4. Able and willing to provide a written informed consent

Exclusion Criteria:

1. 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;

2. Uncontrollable hypertension;

3. PHQ-9 score =15;

4. History of diabetes;

5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

6. 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;

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

8. Use of any medication or treatment that may have caused significant weight change within 2 months;

9. History of bariatric surgery;

10. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

11. Surgery is planned during the trial;

12. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

13. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Drug:
• HRS-7535;Placebo
HRS-7535;Placebo
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in body weight from baseline at Week 26		Week 26
Secondary	Proportion of subjects with weight loss of =5%, =10%, =15% from baseline in body weight at Week 26 and Week 36		Week 26 and Week 36
Secondary	Percent change in body weight from baseline at Week 36		Week 36
Secondary	Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in fasting plasma glucoseat Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in fasting serum insulin at Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in HbA1c at Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in total cholesterol (TC) at Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36		Week 26 and Week 36
Secondary	Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3		Week 26 and Week 3
Secondary	Change from baseline in triglycerides (TG) at Week 26 and Week 36		Week 26 and Week 36