Overweight or Obesity; Type 2 DiabetesPhase 1NCT06435676
A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects
A Phase 1 study testing HRS9531 in people with Overweight or Obesity; Type 2 Diabetes, 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 single and multiple doses of HRS9531tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity; Type 2 Diabetes
- What is being tested?
- HRS9531
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2024to 8 Oct 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- 18-55 years of age at the time of signing informed consent.
- SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
- Subjects with good general health, no clinically significant abnormalities.
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
- Abnormal and clinically significant blood pressure at screening.
- Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
- Participation in other clinical trials.
- Presence of any clinically significant results in examination at screening visit.
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- Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
- Presence of - clinically significant ECG results.
- Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
- Addiction to tobacco and alcohol.
- In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital Of Anhui medical University
Hefei, Anhui, 230601
About this study
Official title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.
- Conditions
- Overweight or Obesity; Type 2 Diabetes
- Being tested
- HRS9531, Placebo
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
Single dose escalation of HRS9531 tablets in healthy subjects
PlaceboDrug
Single dose of placebo in healthy adults
HRS9531Drug
Multiple dose escalation of HRS9531 tablets in healthy subjects
PlaceboDrug
Multiple dose of placebo in healthy adults
| Study group | Role | What they receive |
|---|---|---|
| SAD Stage: HRS9531 | Experimental | Administered po once Receives: Drug: HRS9531 |
| SAD Stage: placebo | Placebo comparator | Administered po once Receives: Drug: Placebo |
| MAD Stage: HRS9531 | Experimental | Administered po for multiple dose Receives: Drug: HRS9531 |
| MAD Stage: placebo | Placebo comparator | Administered po for multiple dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD Stage: Number of Adverse Events
Measured: 36 days
MAD Stage: Number of Adverse Events
Measured: 63 days
Secondary outcomes (7)
Plasma Concentration-Time to Peak (Tmax) of HRS9531
Tmax of a single dose of HRS9531 tablets
Measured: 36 days
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
AUC of a single dose of HRS9531 tablets
Measured: 36 days
Immunogenicity qualitative
anti-HRS9531 antibody
Measured: 36 days
Plasma Concentration-Time to Peak (Tmax) of HRS9531
Tmax of multiple dose of HRS9531 tablets
Measured: 63 days
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
AUC of multiple dose of HRS9531 tablets
Measured: 63 days
Glucose
fasting plasma glucose
Measured: 35 days
Immunogenicity qualitative
anti-HRS9531 antibody
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start4 Jun 2024
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obesity; Type 2 DiabetesStudies 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
- Model description
- randomized, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 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
- NCT06435676
- Sponsor's protocol ID
- HRS9531-T-101
- Status last verified
- May 2025
- First submitted
- 24 May 2024
- Last updated
- 22 May 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06435676
- Acronym / sponsor ID
- HRS9531-T-101
- Conditions
- Overweight or Obesity; Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 30 May 2024 (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 single and multiple doses of HRS9531tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| SAD Stage: HRS9531 | Experimental | Drug: HRS9531Administered po once |
| SAD Stage: placebo | Placebo comparator | Drug: PlaceboAdministered po once |
| MAD Stage: HRS9531 | Experimental | Drug: HRS9531Administered po for multiple dose |
| MAD Stage: placebo | Placebo comparator | Drug: PlaceboAdministered po for multiple dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to understand the trial procedures, be able and willing to provide a written informed consent.
- 18-55 years of age at the time of signing informed consent.
- SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
- Subjects with good general health, no clinically significant abnormalities.
Key exclusion criteria (11 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
- Abnormal and clinically significant blood pressure at screening.
- Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
- Participation in other clinical trials.
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 |
|---|---|---|
| HRS9531Single dose escalation of HRS9531 tablets in healthy subjects | Drug | SAD Stage: HRS9531 |
| PlaceboSingle dose of placebo in healthy adults | Drug | SAD Stage: placebo |
| HRS9531Multiple dose escalation of HRS9531 tablets in healthy subjects | Drug | MAD Stage: HRS9531 |
| PlaceboMultiple dose of placebo in healthy adults | Drug | MAD Stage: placebo |
Primary outcome
SAD Stage: Number of Adverse Events
Time frame: 36 days
MAD Stage: Number of Adverse Events
Time frame: 63 days
7 secondary outcomes
Plasma Concentration-Time to Peak (Tmax) of HRS9531
Time frame: 36 days
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
Time frame: 36 days
Immunogenicity qualitative
Time frame: 36 days
Plasma Concentration-Time to Peak (Tmax) of HRS9531
Time frame: 63 days
Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
Time frame: 63 days
Glucose
Time frame: 35 days
Immunogenicity qualitative
Time frame: 63 days
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 22 May 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 in people with Overweight or Obesity; Type 2 Diabetes, 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 4 inclusion and 11 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 22 May 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. 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?
SAD Stage: Number of Adverse Events (time frame: 36 days). The study lists 2 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 22 May 2025.