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CompletedNCT06762600Updated Apr 30, 2026

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

A Phase 1 interventional study of HRS-4729 injection and HRS-4729 injection placebo in Overweight or Obesity, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Overweight or Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 102 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Treatment group 1

    Drug: HRS-4729 injection · Drug: Acetaminophen

  • Placebo comparator
    Treatment group 2

    Drug: HRS-4729 injection placebo · Drug: Acetaminophen

  • Experimental
    Treatment group 3

    Drug: HRS9531 injection

  • Placebo comparator
    Treatment group 4

    Drug: HRS9531 injection placebo

Interventions

  • DrugHRS-4729 injection

    HRS-4729 injection

  • DrugHRS-4729 injection placebo

    HRS-4729 injection placebo

  • DrugHRS9531 injection

    HRS9531 injection

  • DrugHRS9531 injection placebo

    HRS9531 injection placebo

  • DrugAcetaminophen

    Acetaminophen

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Screening period up to day 43.

Secondary outcomes

  1. The maximum plasma concentration (Cmax)

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

  2. Time to maximum plasma concentration (Tmax)

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

  3. Terminal half-life (t1/2)

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

  4. Apparent clearance (CL/F)

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

  5. Apparent volume of distribution (Vz/F)

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

  6. Anti-HRS-4729 antibodies

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

  7. Changes from baseline in Fasting Body Weight

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

  8. Changes from baseline in Fasting Plasma Glucose

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

  9. Changes from baseline in Fasting Insulin

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

  10. Changes from baseline in Fasting C-Peptide

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

  11. Total fat mass

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

07

Study locations

1 site
  • Jinan Central Hospital
    Jinan, Shandong 250013, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06762600
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
Jan 16, 2025
Primary completion
Mar 12, 2026
Completion
Mar 12, 2026
Last update
Apr 30, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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