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

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

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

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: Placebo; Drug: HRS-7535;Placebo

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • The First Medical Center of Chinese People's Liberation Army (PLA) General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects will receive escalated dose of HRS-7535 administered orally	Drug: HRS-7535;Placebo; HRS-7535;Placebo
Experimental: Group B; Subjects will receive escalated dose of HRS-7535 administered orally	Drug: HRS-7535;Placebo; HRS-7535;Placebo
Experimental: Group C; Subjects will receive escalated dose of HRS-7535 administered orally	Drug: HRS-7535;Placebo; HRS-7535;Placebo
Experimental: Group D; Subjects will receive escalated dose of HRS-7535 administered orally	Drug: HRS-7535;Placebo; HRS-7535;Placebo
Placebo Comparator: Group E; Subjects will receive Placebo administered orally	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in body weight from baseline at Week 26	Week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percent change in body weight from baseline at Week 36	Week 36
Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36	Week 26 and Week 36
Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36	Week 26 and Week 36
Change from baseline in fasting plasma glucoseat Week 26 and Week 36	Week 26 and Week 36
Change from baseline in fasting serum insulin at Week 26 and Week 36	Week 26 and Week 36
Change from baseline in HbA1c at Week 26 and Week 36	Week 26 and Week 36
Change from baseline in total cholesterol (TC) at Week 26 and Week 36	Week 26 and Week 36
Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36	Week 26 and Week 36
Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3	Week 26 and Week 3
Change from baseline in triglycerides (TG) at Week 26 and Week 36	Week 26 and Week 36

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): January 22, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: HRS-7535-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No