NCT06762600

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

December 31, 2024

Last Update Submit

April 29, 2026

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Screening period up to day 43.

Secondary Outcomes (11)

  • The maximum plasma concentration (Cmax)

    Post-dose at day 1 to day 43.

  • Time to maximum plasma concentration (Tmax)

    Post-dose at day 1 to day 43.

  • Terminal half-life (t1/2)

    Post-dose at day 1 to day 43.

  • Apparent clearance (CL/F)

    Post-dose at day 1 to day 43.

  • Apparent volume of distribution (Vz/F)

    Post-dose at day 1 to day 43.

  • +6 more secondary outcomes

Study Arms (4)

Treatment group 1

EXPERIMENTAL
Drug: HRS-4729 injectionDrug: Acetaminophen

Treatment group 2

PLACEBO COMPARATOR
Drug: HRS-4729 injection placeboDrug: Acetaminophen

Treatment group 3

EXPERIMENTAL
Drug: HRS9531 injection

Treatment group 4

PLACEBO COMPARATOR
Drug: HRS9531 injection placebo

Interventions

HRS-4729 injectionDRUG

HRS-4729 injection

Treatment group 1
HRS-4729 injection placeboDRUG

HRS-4729 injection placebo

Treatment group 2
HRS9531 injectionDRUG

HRS9531 injection

Treatment group 3
HRS9531 injection placeboDRUG

HRS9531 injection placebo

Treatment group 4
AcetaminophenDRUG

Acetaminophen

Treatment group 1Treatment group 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • Male or female subjects; aged 18 to 55 years.
  • Self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit).

You may not qualify if:

  • 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.
  • A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery.
  • 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.
  • Participation in any drug or medical device clinical trial within 3 months prior to screening.
  • 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.
  • Clinically significant abnormalities on 12-lead ECG as determined by the investigator.
  • Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 7, 2025

Study Start

January 16, 2025

Primary Completion

March 12, 2026

Study Completion

March 12, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

CN(1)