A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity

NCT07285902 | Active Not Recruiting Phase 3

• 1 other identifier: HRS9531-308
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 2

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in body weight after 52 weeks of treatment

  52 weeks

Secondary Outcomes (10)

• 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

Study Arms (2)

Treatment group A: HRS9531 injection

EXPERIMENTAL

Drug: HRS9531 injection

Treatment group B: Semaglutide Injection

ACTIVE COMPARATOR

Drug: Semaglutide Injection

Interventions

HRS9531 injection DRUG

HRS9531 injection

Treatment group A: HRS9531 injection

Semaglutide Injection DRUG

Semaglutide Injection

Treatment group B: Semaglutide Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• obesity
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Chiness PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

CN (2)