Overweight or ObesityPhase 1NCT06762600
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects
A Phase 1 study testing HRS-4729 injection, HRS9531 injection and Acetaminophen in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- HRS-4729 injection, HRS9531 injection and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2025to 12 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.
- Conditions
- Overweight or Obesity
- Being tested
- HRS-4729 injection, HRS-4729 injection placebo, HRS9531 injection, HRS9531 injection placebo, Acetaminophen
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4729 injectionDrug
HRS-4729 injection
HRS-4729 injection placeboDrug
HRS-4729 injection placebo
HRS9531 injectionDrug
HRS9531 injection
HRS9531 injection placeboDrug
HRS9531 injection placebo
AcetaminophenDrug
Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Not described Receives: Drug: HRS-4729 injection; Drug: Acetaminophen |
| Treatment group 2 | Placebo comparator | Not described Receives: Drug: HRS-4729 injection placebo; Drug: Acetaminophen |
| Treatment group 3 | Experimental | Not described Receives: Drug: HRS9531 injection |
| Treatment group 4 | Placebo comparator | Not described Receives: Drug: HRS9531 injection placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Screening period up to day 43.
Secondary outcomes (11)
The maximum plasma concentration (Cmax)
Measured: Post-dose at day 1 to day 43.
Time to maximum plasma concentration (Tmax)
Measured: Post-dose at day 1 to day 43.
Terminal half-life (t1/2)
Measured: Post-dose at day 1 to day 43.
Apparent clearance (CL/F)
Measured: Post-dose at day 1 to day 43.
Apparent volume of distribution (Vz/F)
Measured: Post-dose at day 1 to day 43.
Anti-HRS-4729 antibodies
Measured: Post-dose at day 1 to day 43.
Changes from baseline in Fasting Body Weight
Measured: Run-in Period up to Day 113.
Changes from baseline in Fasting Plasma Glucose
Measured: Run-in Period up to Day 113.
Changes from baseline in Fasting Insulin
Measured: Run-in Period up to Day 113.
Changes from baseline in Fasting C-Peptide
Measured: Run-in Period up to Day 113.
Total fat mass
Measured: Run-in Period up to Day 113.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start16 Jan 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762600
- Sponsor's protocol ID
- HRS-4729-101
- Status last verified
- Apr 2026
- First submitted
- 31 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06762600
- Acronym / sponsor ID
- HRS-4729-101
- Conditions
- Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: HRS-4729 injection, Drug: Acetaminophen |
| Treatment group 2 | Placebo comparator | Drug: HRS-4729 injection placebo, Drug: Acetaminophen |
| Treatment group 3 | Experimental | Drug: HRS9531 injection |
| Treatment group 4 | Placebo comparator | Drug: HRS9531 injection placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-4729 injectionHRS-4729 injection | Drug | Treatment group 1 |
| HRS-4729 injection placeboHRS-4729 injection placebo | Drug | Treatment group 2 |
| HRS9531 injectionHRS9531 injection | Drug | Treatment group 3 |
| HRS9531 injection placeboHRS9531 injection placebo | Drug | Treatment group 4 |
| AcetaminophenAcetaminophen | Drug | Treatment group 1, Treatment group 2 |
Primary outcome
Adverse events (AEs)
Time frame: Screening period up to day 43.
11 secondary outcomes
The maximum plasma concentration (Cmax)
Time frame: Post-dose at day 1 to day 43.
Time to maximum plasma concentration (Tmax)
Time frame: Post-dose at day 1 to day 43.
Terminal half-life (t1/2)
Time frame: Post-dose at day 1 to day 43.
Apparent clearance (CL/F)
Time frame: Post-dose at day 1 to day 43.
Apparent volume of distribution (Vz/F)
Time frame: Post-dose at day 1 to day 43.
Anti-HRS-4729 antibodies
Time frame: Post-dose at day 1 to day 43.
Changes from baseline in Fasting Body Weight
Time frame: Run-in Period up to Day 113.
Changes from baseline in Fasting Plasma Glucose
Time frame: Run-in Period up to Day 113.
Changes from baseline in Fasting Insulin
Time frame: Run-in Period up to Day 113.
Changes from baseline in Fasting C-Peptide
Time frame: Run-in Period up to Day 113.
Total fat mass
Time frame: Run-in Period up to Day 113.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-4729 injection, HRS9531 injection and Acetaminophen in people with Overweight or Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Screening period up to day 43.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.