To Explore the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Multiple Doses of HRS-7535 in Obese Subjects

Shandong Suncadia Medicine Co., Ltd.1 site in 1 country74 target enrollmentOctober 30, 2024

ConditionsOverweight or Obesity

InterventionsPlacebo HRS-7535 Tablet

DrugsHRS-7535 Tablet Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Overweight or Obesity
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 74
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of HRS-7535 tablet in obese subjects.

Registry

clinicaltrials.gov

Start Date

October 30, 2024

End Date

June 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able and willing to provide a written informed consent.
•At screening: BMI ≥30 kg/m
•Have been controlled by diet and exercise for 3 months or more before screening, and the change in body weight in the past 3 months is less than 5%.
•Male and female subjects of childbearing potential through signing the informed consent form to 1 month after the last dose have no family plans and must use highly effective contraception, and female participants of childbearing potential also must have no plans to donate eggs (male participants must have no plans to be sperm donors); Female subjects of childbearing potential must have a serum pregnancy test within 7 days prior to the date of randomization, including the day of randomization.

Exclusion Criteria

•Clinically significant abnormalities in relevant laboratory tests at screening.
•The results of the electrocardiogram at screening show clinically significant abnormalities that may affect the safety of the subject, including but not limited to myocardial infarction, severe arrhythmias such as supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.
•Heart rate or pulse \> 100 beats per minute or ECG QTcF \>450 ms at screening.
•The PHQ-9 score ≥ 15 points.
•Poor blood pressure control at screening.
•Presence or history of endocrine disease that may significantly affect body weight at screening.
•History of diabetes mellitus.
•Within 6 months prior to screening, the subject has the following diseases of clinical significance: including but not limited to neurological, psychiatric, cardiovascular, endocrine, gastrointestinal, respiratory, urinary, blood, immune system and other diseases, which may interfere with the trial results or pose additional risks to the administration of the study drug as judged by the investigator.
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type
•Previous or known history of acute or chronic pancreatitis, history of cholecystitis or history of gallstones, chronic malabsorption syndrome or cholestasis.