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RecruitingPhase 1

Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects

A Phase I Clinical Study Comparing the Relative Bioavailability, Safety and Tolerability of the First-generation and Second-generation Formulations of HRS9531 Tablets and Exploring the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Escalation of the Second-generation Formulation

Asset

HRS9531

Oral · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

168

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 24-35

Primary endpoints

Area under the curveTreatment-emergent AEs (any)Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07150962
Org study IDHRS9531-T-103

Timeline

Milestones

Study first posted2025-09-02actual
Study start2025-10-15actual
Last update posted2025-11-17actual
Primary completion2026-02estimated (month precision)
Study completion2026-09estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;

2. Male subjects aged 18-55 years on the date of signing informed consent (inclusive);

3. Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive);

4. The weight change within the previous 3 months should not exceed 5 kilograms.

5. Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included.

Exclusion criteria

1. Those who are known or suspected to be allergic to any component of the investigational drug or related products; or those who have a history of multiple or severe allergies to drugs or foods, or a history of severe immediate allergic reactions;

2. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study;

3. Having a history of hypertension or when the researchers determine during the screening that the blood pressure is abnormal and has clinical significance;

4. Those with a history of obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), conditions that affect gastric emptying (such as pyloric stenosis), or who have undergone any gastrointestinal surgery (such as weight loss surgery; except for intestinal polyp resection and appendectomy), or who had acute diarrhea within the previous 7 days; diarrhea is defined as watery stools and/or more than 3 bowel movements per day;

5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing;

6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing;

7. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;

8. Those who have a history of drug abuse or drug use, or who have a positive result in the urine drug screening test during the screening period;

9. Heavy drinkers (average weekly alcohol consumption of ≥ 14 units in the six months prior to screening: 1 unit of beer = 285 mL, or spirits = 25 mL, or wine = 100 mL; average daily smoking ≥ 5 cigarettes); those unable to quit smoking and drinking during the trial; those with positive alcohol blood tests.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau)

Time frame:From Day 14 to Day 15.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Adverse event (AE)

Time frame:Screening period up to Day 35.

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Serious adverse event (SAE)

Time frame:Screening period up to Day 35.

Serious AEs (any)

event count, event

Secondary/protocol endpoint

The maximum plasma concentration (Cmax)

Time frame:On the 35th day after continuous administration.

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma concentration (Tmax)

Time frame:On the 35th day after continuous administration.

Tmax

descriptive

Secondary/protocol endpoint

Area under the concentration-time curve (AUC)

Time frame:On the 35th day after continuous administration.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma concentration (Tmax)

Time frame:Post-dose from Day 1 to Day 183.

Tmax

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.