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Can a daily pill help shed pounds? a new trial puts HRS-7535 to the test.

NCT ID NCT06904105

Disease control Sponsor: Shandong Suncadia Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether an experimental oral drug called HRS-7535 can help people with overweight or obesity lose weight. About 556 adults aged 18 to 75 with a body mass index (BMI) of 24 or higher (or 28 or higher) are taking either HRS-7535 or a placebo daily. Researchers are measuring weight loss and checking for side effects to see if the drug is both effective and safe.

What this could mean

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

Active substance
an experimental oral drug called HRS-7535
What this could lead to
If successful, this could offer a new oral medication for weight loss in people who are overweight or obese.
What could go wrong
This is an early phase 3 trial, so the drug may not prove effective or could have side effects. Results may not apply to everyone.

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

556 people

The number who actually took part.

Started

Apr 2025

Finished

Jun 2026

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 to 75 years

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. On the day of signing the informed consent form, the age should be between 18 and 75 years old. 2. At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease. 3. The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%. 4. Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study. Exclusion Criteria: 1. At the screening period, relevant laboratory test results are abnormal. 2. Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities. 3. Uncontrolled severe hypertension at the screening period. 4. Presence of endocrine diseases that may significantly affect the body weight. 5. History of acute or chronic pancreatitis. 6. History of significant gastrointestinal diseases. 7. Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator. 8. Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening. 9. Known or suspected abuse of alcohol or narcotics. 10. Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

Obesity Overweight

Contacts and locations

Locations

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100039, China

More trials for these conditions

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