A phase 1, Single-Center, randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following Single-Dose administration in healthy participants and Multiple-Dose administration in obese participants, and the effect of food on the pharmacokinetics of HRS-1597 tablets

NCT ID NCT07808918

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.

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

About 78 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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 to 55 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. Aged 18 to 55 years (inclusive), both male and female. 2. Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 19-26 kg/m² (inclusive). Part 2 (MAD): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 28-35 kg/m² (inclusive). 3. Male and female participants of childbearing potential and their partners agree to have no plans for pregnancy or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last dose, and voluntarily agree to use highly effective contraceptive measures. Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose (baseline period), and must not be lactating. Exclusion Criteria: \- General Conditions: 1. Smoking more than 5 cigarettes (or other nicotine-containing products) per day within 3 months prior to screening, or planning to use any tobacco products during the study period. 2. History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture. 3. Clinically significant abnormalities in physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, and coagulation function), chest imaging, abdominal ultrasound, or 12-lead electrocardiogram (ECG), as judged by the investigator. 4. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), syphilis antibody, or human immunodeficiency virus (HIV) antibody. History of Any of the Following Diseases or Conditions: 5. Suspected allergy to the investigational product or any of its components, or a history of severe allergy to any drug, food, toxin, or other exposure. 6. History of liver disease. 7. History of diabetes or pre-diabetes. 8. Diagnosis of malignancy or history of malignant tumors. 9. History of any clinically significant disease or condition that, in the investigator's opinion, may affect the study results, including but not limited to disorders of the circulatory, endocrine, neurological, digestive, urinary, hematopoietic, immune, psychiatric, or metabolic systems; or any condition that may affect the study results, drug absorption, distribution, metabolism, or excretion, or place the participant at undue risk. Current or Prior Use of the Following Medications: 10. Use of any prescription drugs, over-the-counter drugs (including natural health products, with the exception of routine vitamins), herbal medicines, or live (attenuated) vaccines within 1 month or 5 half-lives of the drug (whichever is longer) prior to baseline. 11. Refusal to abstain from any beverages or foods containing methylxanthines (e.g., coffee, tea, cola, chocolate, etc.) from 48 hours prior to baseline through the end of the study; refusal to abstain from any beverages or foods containing grapefruit from 7 days prior to baseline through the end of the study; or special dietary requirements that prevent compliance with a standardized diet.

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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

  • The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

    Hefei, Anhui, 310000, China