Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516966
• Other study ID #: HRS9531-102
• Status: Recruiting
• Phase: Phase 1
• Start date: October 12, 2022
• Est. completion date: May 3, 2023

Study information

• Verified date: August 2022
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: Hong Chen
• Phone: 0518-82342973
• Email: hong.chen[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 3, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.

2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.

3. Treated with conventional lifestyle intervention alone or stable treatment with metformin (=1000 mg/day) at least 8 weeks prior to screening.

4. 7.0% = HbA1c =10.5% at screening.

Exclusion Criteria:

1. 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.

2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.

3. 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.

4. Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;

5. Participants in clinical trials of any drug or medical device in the 3 months prior to screening.

6. Breast-feeding women.

7. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• HRS9531
Administrated SC
• Placebo
Administrated SC
• Dulaglutide Injection
Administrated SC

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (Safety and Tolerability)	A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events	Screening period up to Day 62
Secondary	Area Under the Concentration Versus Time Curve (AUC) of HRS9531		Start of Treatment up to Day 62
Secondary	Maximum Concentration (Cmax) of HRS9531		Start of Treatment up to Day 62
Secondary	Change from Baseline in Fasting Blood Glucose (FBG)		Baseline up to Day 62
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline up to Day 29
Secondary	Change from Baseline in Weight		Baseline up to Day 62
Secondary	Immunogenicity: anti-HRS9531 antibody		Start of Treatment up to Day 62