Type 2 DiabetesPhase 1NCT05152277
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects
A Phase 1 study testing HRS9531 in people with 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 subcutaneous injections of HRS9531 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
- Type 2 Diabetes
- What is being tested?
- HRS9531
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to 24 Aug 2022
- 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
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- Age 18-55 years on the date of signing informed consent (inclusive);
- Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive);
- Subjects with good general health, no clinically significant abnormalities.
Who cannot join
- 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;
- Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
- Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
- Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months;
- Allergic constitution includes severe drug allergy or history of drug allergy;
- Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive;
- Breast-feeding women;
- The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS9531, placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
Administered SC once
placeboOther
Administered SC once
HRS9531Drug
Administered SC for multiple dose
placeboOther
Administered SC for multiple dose
| Study group | Role | What they receive |
|---|---|---|
| Single dose escalation of HRS9531 injection in healthy subjects | Experimental | Not described Receives: Drug: HRS9531 |
| Single dose of placebo in healthy adults | Placebo comparator | Not described Receives: Other: placebo |
| Multiple dose escalation of HRS9531 injection in healthy subjects | Experimental | Not described Receives: Drug: HRS9531 |
| Multiple dose of placebo in healthy adults | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
A summary of adverse events, including Serious Adverse Events(SAEs)
Measured: Start of Treatment to end of study (approximately 7 weeks or 9 weeks)
Secondary outcomes (5)
Area under the plasma concentration-time curve (AUC) of HRS9531
AUC of HRS9531 after single subcutaneous injection
Measured: Start of Treatment to end of study (approximately 7 weeks)
Immunogenicity qualitative
anti-HRS9531 antibody
Measured: Start of Treatment to end of study (approximately 7 weeks)
AUC of HRS9531
AUC of HRS9531 after multiple subcutaneous injections
Measured: Start of Treatment to end of study (approximately 9 weeks)
Immunogenicity qualitative
anti-HRS9531 antibody
Measured: Start of Treatment to end of study (approximately 9 weeks)
Glucose concentration
fasting plasma glucose
Measured: Start of Treatment to end of study (approximately 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start6 Dec 2021
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS9531 compared with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT05152277
- Sponsor's protocol ID
- HRS9531-101
- Status last verified
- Sep 2022
- First submitted
- 29 Nov 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He K, Wei Y, Zhao H, Zhang L, Wu F, Liu R, Zhang Y, Wang Y, Chen H, Zeng M, Zhi L, Zhou T, Sheng Z, Wen Q. Preclinical and First-In-Human Evaluation of Ribupatide (HRS9531), a Dual GLP-1/GIP Receptor Agonist. Diabetes Obes Metab. 2026 Sep 20. doi: 10.1111/dom.71218. Online ahead of print.
PubMed 42764407
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered HRS9531
- ClinicalTrials.gov ID
- NCT05152277
- Acronym / sponsor ID
- HRS9531-101
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 9 Dec 2021 (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 subcutaneous injections of HRS9531 in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- HRS9531 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Single dose escalation of HRS9531 injection in healthy subjects | Experimental | Drug: HRS9531 |
| Single dose of placebo in healthy adults | Placebo comparator | Other: placebo |
| Multiple dose escalation of HRS9531 injection in healthy subjects | Experimental | Drug: HRS9531 |
| Multiple dose of placebo in healthy adults | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- Age 18-55 years on the date of signing informed consent (inclusive);
- Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive);
- Subjects with good general health, no clinically significant abnormalities.
Key exclusion criteria (8 listed)
- 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;
- Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
- Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
- Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months;
- Allergic constitution includes severe drug allergy or history of drug allergy;
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 |
|---|---|---|
| HRS9531Administered SC once | Drug | Single dose escalation of HRS9531 injection in healthy subjects |
| placeboAdministered SC once | Other | Single dose of placebo in healthy adults |
| HRS9531Administered SC for multiple dose | Drug | Multiple dose escalation of HRS9531 injection in healthy subjects |
| placeboAdministered SC for multiple dose | Other | Multiple dose of placebo in healthy adults |
Primary outcome
Number of Adverse Events
Time frame: Start of Treatment to end of study (approximately 7 weeks or 9 weeks)
A summary of adverse events, including Serious Adverse Events(SAEs)
5 secondary outcomes
Area under the plasma concentration-time curve (AUC) of HRS9531
Time frame: Start of Treatment to end of study (approximately 7 weeks)
Immunogenicity qualitative
Time frame: Start of Treatment to end of study (approximately 7 weeks)
AUC of HRS9531
Time frame: Start of Treatment to end of study (approximately 9 weeks)
Immunogenicity qualitative
Time frame: Start of Treatment to end of study (approximately 9 weeks)
Glucose concentration
Time frame: Start of Treatment to end of study (approximately 9 weeks)
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 19 Sep 2022.
- Derived from this study: PubMed 42764407He K, Wei Y, Zhao H, Zhang L, Wu F, Liu R, Zhang Y, Wang Y, Chen H, Zeng M, Zhi L, Zhou T, Sheng Z, Wen Q. Preclinical and First-In-Human Evaluation of Ribupatide (HRS9531), a Dual GLP-1/GIP Receptor Agonist. Diabetes Obes Metab. 2026 Sep 20. doi: 10.1111/dom.71218. Online ahead of print.
- 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 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 8 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 19 Sep 2022. 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?
Number of Adverse Events (time frame: Start of Treatment to end of study (approximately 7 weeks or 9 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152277, which also lists 1 linked publication.
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 19 Sep 2022.