← Trials/Trial dossier/NCT07285902

Active not recruitingPhase 3

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

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

Assets

HRS9531 / Semaglutide

Listed sites

2

Recruiting sites

Enrollment

572

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07285902
Org study IDHRS9531-308

Timeline

Milestones

Study first posted2025-12-16actual
Study start2025-12-25actual
Last update posted2026-02-27actual
Primary completion2027-03estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. 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;

2. Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;

3. obesity

4. Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.

5. 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

1. Those with abnormal relevant examinations at screening;

2. ECG results are abnormal and may affect the safety of the subject

3. Poor blood pressure control

4. The PHQ-9 score ≥ 15 points

5. Presence or history of endocrine disorders that may significantly affect body weight

6. History of diabetes mellitus

7. Those who have had any previous disease or history that affects gastric emptying, or who have undergone gastrointestinal surgery

8. Previous or known history of acute or chronic pancreatitis, pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatment-inducing gallbladder disease

9. Previous or known history or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2).

10. Severe infection, severe trauma, or large and medium-sized surgery within 1 month prior to screening

11. History of severe cardiovascular and cerebrovascular diseases within the previous 6 months

12. Malignancy of any organ system within 5 years

13. Presence or suspicion of depression, bipolar disorder, suicidal tendencies, People with schizophrenia or other more serious mental illness

14. Known or suspected history of alcohol and/or drug abuse or drug abuse

15. Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease

16. Presence of any hematologic disorder that may interfere with HbA1c detection

17. Presence of autoimmune disease with planned use of systemic glucocorticoids or immunosuppressive therapy during the study

18. Use of medications or treatments that may result in significant weight gain or loss within the previous 3 months

19. Received, or planned to undergo bariatric surgery or endoscopic and/or medical device-based bariatric therapy during the study, etc

20. Those who have a known or suspected allergy to the same or related products of the investigational drug and their excipients

21. Previous discontinuation of this class for safety/tolerability reasons

22. Participation in a clinical trial of any drug or medical device within 3 months prior to screening

23. Those who have donated or lost ≥ 400 mL of blood within the previous 3 months, or have received blood transfusions

24. Surgery is planned for the duration of the trial

25. Subjects who are mentally incapacitated or have language impairment who are unable to fully understand or participate in the trial process

26. 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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Glycemic / diabetes
3
MASH / liver
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

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

Time frame:52 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of subjects with target reduction from baseline in body weight after 52 weeks of treatment

Time frame:52 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference,after 52 weeks of treatment

Time frame:52 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight after 52 weeks of treatment

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment

Time frame:52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment

Time frame:52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting serum insulin after 52 weeks of treatment

Time frame:52 weeks

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline in liver enzymes after 52 weeks of treatment

Time frame:52 weeks

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from baseline in lipid parameters after 52 weeks of treatment

Time frame:52 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of AEs during the trial.

Time frame:52 weeks

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment

Time frame:52 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.