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Liver health may affect new diabetes Drug's safety

NCT ID NCT06961643

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how the experimental diabetes drug HRS-7535 behaves in people with mild or moderate liver impairment compared to those with normal liver function. Twenty-four adults completed the trial, which measured drug levels in the blood and checked for side effects. The goal was to understand if liver problems change how the drug is processed, which could guide future dosing recommendations.

What this could mean

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

Active substance
HRS-7535 (oral tablet)
What this could lead to
If successful, this study could help determine safe dosing of HRS-7535 for people with liver problems who need diabetes treatment.
What could go wrong
This is a very early Phase 1 study with only 24 people, focused on safety and drug levels, not on treating diabetes. Results may not apply to broader populations.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Jun 2025

Finished

Jan 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 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing. 2. Aged 18-70 years old on the date of signing the ICF (including the threshold), both male and female. 3. At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 18\~32 kg/m2 (including the threshold). Exclusion Criteria: 1. In the judgment of the investigator, may be allergic to the study drug or its components. 2. Smoking an average of more than 10 cigarettes per day within 3 months prior to screening. 3. Alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 mL of alcohol, or 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine. 4. History of drug or substance abuse, or a positive urine drug test at screening. 5. Donated or lost ≥ 400 mL of blood within 3 months prior to screening. 6. Individuals with a history of severe hypoglycemia. 7. Undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus

Contacts and locations

Locations

  • Henan Provincial Infectious Disease Hospital

    Zhengzhou, Henan, 450015, China

More trials for these conditions

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