A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses

September 21, 2026 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study

This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
        • Principal Investigator:
          • Qing Wen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
  2. The age range is from 18 to 55 years old (inclusive at both ends).
  3. Weight ≥ 50.0 kg.
  4. They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).

Exclusion Criteria:

  1. During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
  2. The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
  3. During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
  4. Diabetes (except gestational diabetes).
  5. Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
  6. Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial.
  7. Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result.
  8. Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration.
  9. Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
  10. Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HRS-1596 Group

HRS-1596, healthy subjects or obese subjects.
Drug: HRS-1596

HRS-1596.
Placebo Comparator: HRS-1596 Placebo Group

HRS-1596 placebo, healthy subjects or obese subjects.
Drug: HRS-1596 Placebo

HRS-1596 placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence and severity of adverse events (AEs)
Time Frame: Screening period up to Day 84.
Screening period up to Day 84.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The maximum plasma concentration (Cmax)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Time to maximum plasma concentration (Tmax)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Terminal half-life (t1/2)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Anti-HRS-1596 Antibodies (ADAs)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.
Fasting plasma glucose (FPG)
Time Frame: Post-dose at Day 1 to Day 84.
Post-dose at Day 1 to Day 84.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-1596-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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