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CompletedPhase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of HRS-4729 Injection in Healthy Subjects

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

102

actual

Study population

Healthy volunteers

Key I/E criterion

Primary endpoint

Treatment-emergent 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 IDNCT06762600
Org study IDHRS-4729-101

Timeline

Milestones

Study first posted2025-01-07actual
Study start2025-01-16actual
Primary completion2026-03-12actual
Study completion2026-03-12actual
Last update posted2026-04-30actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Voluntarily provides written informed consent prior to the initiation of any study-related activities and demonstrates understanding of the procedures and methods involved in the study, agreeing to adhere strictly to the clinical trial protocol to complete the study.

2. Male or female subjects; aged 18 to 55 years.

3. Self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit).

Exclusion criteria

1. A history of current significant disease in the neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, genitourinary, endocrine, hematologic, or immune systems, as determined by the investigator, which would render the subject unsuitable for participation in this trial.

2. A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery.

3. Subjects who have had a major surgery or severe trauma within 6 months prior to screening, or who are planned for surgical procedures during the trial period.

4. Participation in any drug or medical device clinical trial within 3 months prior to screening.

5. Any abnormal physical examination, vital signs, laboratory tests, chest X-ray and abdominal ultrasound findings deemed clinically significant by the investigator, rendering the subject unsuitable for participation.

6. Clinically significant abnormalities on 12-lead ECG as determined by the investigator.

7. Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.

Endpoints (12)

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.

Coverage by outcome category

Safety / tolerability / PK
7
Glycemic / diabetes
3
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Changes from baseline in Fasting Body Weight

Time frame:Run-in Period up to Day 113.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Total fat mass

Time frame:Run-in Period up to Day 113.

Total fat mass

descriptive, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Changes from baseline in Fasting Plasma Glucose

Time frame:Run-in Period up to Day 113.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes from baseline in Fasting Insulin

Time frame:Run-in Period up to Day 113.

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline in Fasting C-Peptide

Time frame:Run-in Period up to Day 113.

change from baseline, improvement

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Adverse events (AEs)

Time frame:Screening period up to day 43.

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

The maximum plasma concentration (Cmax)

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

Cmax

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

Anti-HRS-4729 antibodies

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

Immunogenicity (ADA)

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.