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CompletedPhase 1

The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution

A Single-center, Single-dose, Randomized, Open-label, Single-period, Parallel Bioequivalence Study of HRS9531 Injection Solution in Multi-dose Pens and Single-dose Pens in Overweight/Obese Subjects

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

120

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoints

CmaxArea under the concentration curve from time 0 to the last quantifiableArea under the concentration curve from time 0 to extrapolated infinite time

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 IDNCT06792955
Org study IDHRS9531-108

Timeline

Milestones

Study first posted2025-01-27actual
Study start2025-02-11actual
Primary completion2025-06-06actual
Study completion2025-06-06actual
Last update posted2025-06-12actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Subjects must provide informed consent prior to the trial, demonstrating a full understanding of the trial's content, procedures and potential adverse reactions, and willingly sign a written informed consent form. They must also be willing and capable of adhering to the trial protocol to complete the study.

2. On the day of signing the informed consent form, the subjects must be overweight/obese males or females aged 18 to 45 years inclusive of the boundary values.

3. From the time of signing the informed consent form until two months after the last drug administration, subjects must have no plans for conception (for both male and female subjects) and must voluntarily adopt effective contraceptive measures. They must also have no plans to donate eggs/sperm. Female subjects of reproductive potential must have a negative pregnancy test.

Exclusion criteria

1. Subjects with a history of primary diseases in major organs, including but not limited to the nervous system, mental system, cardiovascular system, digestive system, respiratory system, urinary system, endocrine system, hematopoietic system and immune system, as judged by the investigator to be unsuitable for participation in this trial.

2. Subjects with a history of significant gastric emptying abnormalities or factors affecting gastric emptying, or clinically significant gastrointestinal diseases, or those who have undergone gastrointestinal surgery (excluding polypectomy, appendectomy and hemorrhoidectomy).

3. Subjects who have undergone any surgery within 6 months prior to dosing, or those planning to undergo surgical procedures during the study period.

4. Subjects who have experienced blood loss or donated blood ≥400 mL within 3 months prior to dosing or ≥200 mL within 1 month prior to dosing, or those who have received a blood transfusion within 3 months prior to dosing.

5. Subjects who are positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCVAb), Human Immunodeficiency Virus (HIV) antibody or Treponema pallidum-specific antibody.

6. Subjects with a history of drug use or abuse within 1 year prior to dosing, or those with a positive drug screen.

7. Subjects who are heavy users of alcohol and tobacco (consuming an average of ≥14 units of alcohol per week for the 6 months prior to screening: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine; smoking ≥5 cigarettes per day on average) and who are unable to abstain as required by the protocol during the trial; those with a positive alcohol screen; those with a positive cotinine screen.

8. Subjects who have consumed foods or beverages containing methylxanthines (such as tea, coffee, cola, chocolate, energy drinks) or alcohol, or have engaged in vigorous exercise within 72 hours prior to the first use of the trial medication.

9. Nursing women.

10. Subjects with a history of fainting at the sight of needles or blood, difficulty in drawing blood, or inability to tolerate venous blood collection.

11. Subjects with special dietary habits that the investigator deems unsuitable for participation, or those who cannot follow the dietary requirements of the trial during the study period.

12. Subjects who have received or plan to receive live (attenuated) vaccines within 1 month prior to dosing or during the trial (except for influenza vaccines).

13. Subjects whom the investigator deems to have any other factors that make them unsuitable for this trial, or those who withdraw from the study for personal reasons.

Endpoints (8)

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

8 endpoints
Primary/protocol endpoint

The maximum plasma concentration (Cmax)

Time frame:Post-dose at day 1 to day 43.

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)

Time frame:Post-dose at day 1 to day 43.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)

Time frame:Post-dose at day 1 to day 43.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to maximum plasma concentration (Tmax)

Time frame:Post-dose at day 1 to day 43.

Tmax

descriptive

Secondary/protocol endpoint

Terminal half-life (t1/2)

Time frame:Post-dose at day 1 to day 43.

Half-life

descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:Post-dose at day 1 to day 43.

descriptive

Secondary/protocol endpoint

Apparent volume of distribution (Vz/F)

Time frame:Post-dose at day 1 to day 43.

descriptive

Secondary/protocol endpoint

Incidence and severity of adverse events (AEs)

Time frame:Screening period up to day 43.

Treatment-emergent AEs (any)

descriptive, event

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.