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New injection aims to help obese heart failure patients lose weight and feel better

NCT ID NCT06391710

Disease control Sponsor: Fujian Shengdi Pharmaceutical 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 study tests an injectable drug called HRS9531 in 203 obese adults with a type of heart failure where the heart pumps normally but is stiff. Participants receive either the drug or a placebo for 52 weeks. The main goals are to see if the drug helps with weight loss and improves heart-related quality of life.

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, this could point toward a new treatment option that helps obese people with heart failure lose weight and feel better day-to-day.
What could go wrong
This is an early Phase 2 trial with only 203 participants, so results may not apply to everyone. The drug may not improve heart failure outcomes or could cause side effects.

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

203 people

The number who actually took part.

Started

May 2024

Expected to finish

Jan 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 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. Male or female, age above or equal to 18 years at the time of signing informed consent. 2. Body mass index (BMI) greater than or equal to 28.0 kg/m\^2 3. New York Heart Association (NYHA) Class II-IV; 4. Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening Exclusion Criteria: 1. Medical history of myocardial infarction, acute decompensated heart failure, heart failure requiring hospitalization or urgent heart failure visit, unstable angina, stroke, or transient ischemic attack within 30 days prior to or at screening; 2. Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure

As listed by the trial registrant

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

Heart failure with preserved ejection fraction

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020, China

More trials for these conditions

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