Overweight/ObesityPhase 1NCT06792955
The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution
A Phase 1 study testing HRS9531 injection in people with Overweight/Obesity, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the bioequivalence between a single-dose pen and a multi-dose pen of HRS9531 injection solution. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Overweight/Obesity
- What is being tested?
- HRS9531 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2025to 6 Jun 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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.
- 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).
- Subjects who have undergone any surgery within 6 months prior to dosing, or those planning to undergo surgical procedures during the study period.
- 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.
- 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.
- Subjects with a history of drug use or abuse within 1 year prior to dosing, or those with a positive drug screen.
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- 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.
- 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.
- Nursing women.
- Subjects with a history of fainting at the sight of needles or blood, difficulty in drawing blood, or inability to tolerate venous blood collection.
- 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.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Central Hospital Affiliated To Shandong First Medical University
Jinan, Shandong, 250013
About this study
Official title: 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
The study is being conducted to evaluate the bioequivalence between a single-dose pen and a multi-dose pen of HRS9531 injection solution.
- Conditions
- Overweight/Obesity
- Being tested
- HRS9531 injection
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531 injectionDrug
Multi-dose pen of HRS9531 injection solution.
HRS9531 injectionDrug
Single-dose pen of HRS9531 injection solution.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group R | Experimental | Multi-dose pen of HRS9531 injection solution. Receives: Drug: HRS9531 injection |
| Treatment group T | Experimental | Single-dose pen of HRS9531 injection solution. Receives: Drug: HRS9531 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: Post-dose at day 1 to day 43.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
Measured: Post-dose at day 1 to day 43.
Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)
Measured: Post-dose at day 1 to day 43.
Secondary outcomes (5)
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.
Incidence and severity of adverse events (AEs)
Measured: Screening period up to day 43.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start11 Feb 2025
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/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
- None (open label)
- Enrolment
- 120 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
- NCT06792955
- Sponsor's protocol ID
- HRS9531-108
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2025
- Last updated
- 12 Jun 2025
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06792955
- Acronym / sponsor ID
- HRS9531-108
- Conditions
- Overweight/Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 27 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 bioequivalence between a single-dose pen and a multi-dose pen of HRS9531 injection solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group R | Experimental | Drug: HRS9531 injectionMulti-dose pen of HRS9531 injection solution. |
| Treatment group T | Experimental | Drug: HRS9531 injectionSingle-dose pen of HRS9531 injection solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
- 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).
- Subjects who have undergone any surgery within 6 months prior to dosing, or those planning to undergo surgical procedures during the study period.
- 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.
- 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.
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 |
|---|---|---|
| HRS9531 injectionMulti-dose pen of HRS9531 injection solution. | Drug | Treatment group R |
| HRS9531 injectionSingle-dose pen of HRS9531 injection solution. | Drug | Treatment group T |
Primary outcome
The maximum plasma concentration (Cmax)
Time frame: Post-dose at day 1 to day 43.
Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Post-dose at day 1 to day 43.
Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)
Time frame: Post-dose at day 1 to day 43.
5 secondary outcomes
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.
Incidence and severity of adverse events (AEs)
Time frame: Screening period up to day 43.
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 12 Jun 2025.
- 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 HRS9531 injection in people with Overweight/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 13 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 12 Jun 2025. 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. 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?
The maximum plasma concentration (Cmax) (time frame: Post-dose at day 1 to day 43.). The study lists 3 primary outcomes in all. 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 12 Jun 2025.