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New pill aims to tackle heart failure and obesity together

NCT ID NCT06820099

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests an experimental drug called HRS-7535 in 225 adults who have both heart failure (with mildly reduced or preserved pumping ability) and obesity. Participants will receive either the drug or a placebo for 36 weeks to see if it helps with weight loss and reduces inflammation. The goal is to find a new treatment option that manages both conditions at once.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2026

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 to 80 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. Male or female, on the day of signing the informed consent form, aged between 18 and 80 years old; 2. Diagnosed with chronic heart failure for at least 1 months before screening, and diagnosed with heart failure with preserved ejection fraction according to the National Heart Failure Guidelines 2023 during the screening period; 3. Screening period and day 1 randomization before New York Heart Association (NYHA) functional classification II-IV; 4. During the screening period and on the first day before randomization, the body mass index (BMI) was ≥ 28 kg/m2; 5. Self reported having controlled diet and exercise for 3 months or more before screening, and having a weight change of no more than 5kg within the first 3 months of screening and randomization 6. During the screening period and on the first day of randomization, the total clinical score (KCCQ-CSS) of the Kansas City Cardiomyopathy Questionnaire should be ≤ 80 points; 7. Visit 1 and Visit 2 each undergo a 6MWT, both of which must be ≥ 100 meters and ≤ 425 meters; 8. Prior to screening, the stable dose of medication for underlying diseases (excluding oral diuretics) should be ≥ 4 weeks; 9. Capable and willing to comply with the protocol requirements, fully understand the trial content, process, and possible adverse reactions, capable and willing to comply with the protocol requirements to complete this study (such as subject log recording), able to fully understand and complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaire and Patient Health Questionnaire-9 (PHQ-9) scoring. Exclusion Criteria: 1. Individuals with special clinical characteristics or disease history during screening, such as myocardial infarction, acute decompensated heart failure, hospitalization or emergency treatment due to heart failure (excluding hospitalization as specified in the trial protocol), unstable angina, stroke, or transient ischemic attack within the 30 days prior to screening or during the screening period; 2. During the screening period or on the first day of randomization, there may be laboratory tests with clinical significance, such as a 12 lead electrocardiogram indicating persistent sinus tachycardia; 3. Those who have used certain drugs or treatments before screening, such as those that may cause significant weight gain or loss within the past 3 months; 4. Based on the researcher's judgment, there are any situations that may affect the safety of the subjects or interfere with the evaluation of the trial results (such as medical, psychological, social, or geographical factors)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100032, China

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