Clinical trial NCT06671821: Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects
Official title: HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Weight Management
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Treatment-emergent Adverse Event(AE)
timeFrame: During the 32-week open-label extension treatment period
Secondary outcomes:
measure: Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
timeFrame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
measure: 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;
timeFrame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
measure: Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
timeFrame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
measure: Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
timeFrame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
measure: Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
timeFrame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: