Chronic Weight Management
Conditions
Brief summary
The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.
Interventions
DRUGHRS-7535
HRS-7535
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 18-65 years of age at the time of signing informed consent; 2. Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial. 3. Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.
Exclusion criteria
1. Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial; 2. Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period. 3. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Treatment-emergent Adverse Event(AE) | During the 32-week open-label extension treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
| Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; | from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment; |
Countries
China
Outcome results
None listed