NCT07285902RecruitingPhase 3
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of HRS9531 Injection Versus Semaglutide Injection in Subjects With Obesity
Fujian Shengdi Pharmaceutical Co., Ltd.2 sites in 1 country750 target enrollmentStarted: December 25, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 750
- Locations
- 2
- Primary Endpoint
- Percentage change from baseline in body weight after 52 weeks of treatment
Study Overview
Brief Summary
This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •With my consent and has signed the informed consent form, I am willing and able to follow the requirements of the trial protocol to complete this study;
- •Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;
- •Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.
- •Male and female subjects of childbearing potential (including partners) who have no fertility plan and agree to take highly effective contraceptive measures within 2 months after signing the informed consent form to the last dose, and female or male subjects of childbearing potential have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test within 3 days prior to randomization and are not lactating.
Exclusion Criteria
- •Those with abnormal relevant examinations at screening;
- •ECG results are abnormal and may affect the safety of the subject
- •Poor blood pressure control
- •The PHQ-9 score ≥ 15 points
- •Presence or history of endocrine disorders that may significantly affect body weight
- •History of diabetes mellitus
- •Those who have had any previous disease or history that affects gastric emptying, or who have undergone gastrointestinal surgery
- •Previous or known history of acute or chronic pancreatitis, pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatment-inducing gallbladder disease
- •Previous or known history or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2).
- •Severe infection, severe trauma, or large and medium-sized surgery within 1 month prior to screening
- •History of severe cardiovascular and cerebrovascular diseases within the previous 6 months
- •Malignancy of any organ system within 5 years
- •Presence or suspicion of depression, bipolar disorder, suicidal tendencies, People with schizophrenia or other more serious mental illness
- •Known or suspected history of alcohol and/or drug abuse or drug abuse
- •Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease
- •Presence of any hematologic disorder that may interfere with HbA1c detection
- •Presence of autoimmune disease with planned use of systemic glucocorticoids or immunosuppressive therapy during the study
- •Use of medications or treatments that may result in significant weight gain or loss within the previous 3 months
- •Received, or planned to undergo bariatric surgery or endoscopic and/or medical device-based bariatric therapy during the study, etc
- •Those who have a known or suspected allergy to the same or related products of the investigational drug and their excipients
- •Previous discontinuation of this class for safety/tolerability reasons
- •Participation in a clinical trial of any drug or medical device within 3 months prior to screening
- •Those who have donated or lost ≥ 400 mL of blood within the previous 3 months, or have received blood transfusions
- •Surgery is planned for the duration of the trial
- •Subjects who are mentally incapacitated or have language impairment who are unable to fully understand or participate in the trial process
- •Investigators and relevant staff of the research center or other persons directly involved in the implementation of the program, and their immediate family members; Employees of Hengrui Company; In the judgment of the investigator, there is any condition that affects the safety of the subject or any other interference with the evaluation of the test results
Arms & Interventions
Treatment group A: HRS9531 injection
Experimental
Intervention: HRS9531 injection (Drug)
Treatment group B: Semaglutide Injection
Active Comparator
Intervention: Semaglutide Injection (Drug)
Outcomes
Primary Outcomes
Percentage change from baseline in body weight after 52 weeks of treatment
Time Frame: 52 weeks
Secondary Outcomes
- Number of AEs during the trial.(52 weeks)
- Change from baseline in fasting serum insulin after 52 weeks of treatment(52 weeks)
- Change from baseline in lipid parameters after 52 weeks of treatment(52 weeks)
- Proportion of subjects with target reduction from baseline in body weight after 52 weeks of treatment(52 weeks)
- Change from baseline in waist circumference,after 52 weeks of treatment(52 weeks)
- Change from baseline in body weight after 52 weeks of treatment(52 weeks)
- Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment(52 weeks)
- Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment(52 weeks)
- Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment(52 weeks)
- Change from baseline in liver enzymes after 52 weeks of treatment(52 weeks)
Investigators
Study Sites (2)
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