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New obesity drug HRS9531 takes on semaglutide in major trial

NCT ID NCT07285902

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tests whether a new weekly injection called HRS9531 works better than semaglutide for weight loss in 572 adults with obesity. Participants receive either drug for 52 weeks, and researchers measure changes in body weight, waist size, and BMI. The trial is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS9531 injection
What this could lead to
If successful, HRS9531 could offer a new weekly injection option for weight loss that is more effective than current treatments like semaglutide.
What could go wrong
This is a phase 3 trial, but results are not yet available. The new drug may not prove superior or could have unexpected side effects compared to semaglutide.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

572 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chiness PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.