Diabetes Mellitus, Type 2Phase 1NCT05516966
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing HRS9531 and Dulaglutide Injection in people with Diabetes Mellitus, Type 2, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HRS9531 and Dulaglutide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2022to 24 May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
- Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- 7.0% ≤ HbA1c ≤10.5% at screening.
Who cannot join
- History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) or episode of severe hypoglycaemic events within 12 months prior to screening.
- Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
- Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
- 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.
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HRS9531, Placebo, Dulaglutide Injection
- 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
Administrated SC
PlaceboDrug
Administrated SC
Dulaglutide InjectionDrug
Administrated SC
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Receives: Drug: HRS9531; Drug: Placebo |
| Group B | Experimental | Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Receives: Drug: HRS9531; Drug: Placebo |
| Group C | Experimental | Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection Receives: Drug: HRS9531; Drug: Placebo |
| Group D | Active comparator | Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection Receives: Drug: Dulaglutide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Safety and Tolerability)
A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events
Measured: Screening period up to Day 62
Secondary outcomes (6)
Area Under the Concentration Versus Time Curve (AUC) of HRS9531
Measured: Start of Treatment up to Day 62
Maximum Concentration (Cmax) of HRS9531
Measured: Start of Treatment up to Day 62
Change from Baseline in Fasting Blood Glucose (FBG)
Measured: Baseline up to Day 62
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline up to Day 29
Change from Baseline in Weight
Measured: Baseline up to Day 62
Immunogenicity: anti-HRS9531 antibody
Measured: Start of Treatment up to Day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start12 Oct 2022
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- HRS9531 injection compared with placebo and open positive-controlled group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT05516966
- Sponsor's protocol ID
- HRS9531-102
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2022
- Last updated
- 15 Nov 2024
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05516966
- Acronym / sponsor ID
- HRS9531-102
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 26 Aug 2022 (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 main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- HRS9531 injection compared with placebo and open positive-controlled group
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: HRS9531, Drug: PlaceboParticipants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection |
| Group B | Experimental | Drug: HRS9531, Drug: PlaceboParticipants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection |
| Group C | Experimental | Drug: HRS9531, Drug: PlaceboParticipants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection |
| Group D | Active comparator | Drug: Dulaglutide InjectionParticipants receive Dulaglutide 1.5 mg by multiple subcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
- Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- 7.0% ≤ HbA1c ≤10.5% at screening.
Key exclusion criteria (7 listed)
- History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) or episode of severe hypoglycaemic events within 12 months prior to screening.
- Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
- Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
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 |
|---|---|---|
| HRS9531Administrated SC | Drug | Group A, Group B, Group C |
| PlaceboAdministrated SC | Drug | Group A, Group B, Group C |
| Dulaglutide InjectionAdministrated SC | Drug | Group D |
Primary outcome
Incidence of Adverse Events (Safety and Tolerability)
Time frame: Screening period up to Day 62
A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events
6 secondary outcomes
Area Under the Concentration Versus Time Curve (AUC) of HRS9531
Time frame: Start of Treatment up to Day 62
Maximum Concentration (Cmax) of HRS9531
Time frame: Start of Treatment up to Day 62
Change from Baseline in Fasting Blood Glucose (FBG)
Time frame: Baseline up to Day 62
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline up to Day 29
Change from Baseline in Weight
Time frame: Baseline up to Day 62
Immunogenicity: anti-HRS9531 antibody
Time frame: Start of Treatment up to Day 62
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 15 Nov 2024.
- 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 and Dulaglutide Injection in people with Diabetes Mellitus, Type 2, 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 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 15 Nov 2024. 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?
Incidence of Adverse Events (Safety and Tolerability) (time frame: Screening period up to Day 62). 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 15 Nov 2024.