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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HRS9531

Placebo

Dulaglutide Injection

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhongshan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (Safety and Tolerability)

A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events

Secondary Outcome Measures

Area Under the Concentration Versus Time Curve (AUC) of HRS9531

Maximum Concentration (Cmax) of HRS9531

Change from Baseline in Fasting Blood Glucose (FBG)

Change from Baseline in Hemoglobin A1c (HbA1c)

Change from Baseline in Weight

Immunogenicity: anti-HRS9531 antibody

Full Information

NCT ID

NCT05516966

First Posted

August 24, 2022

Last Updated

October 30, 2022

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05516966

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 12, 2022 (Actual)

Primary Completion Date

March 29, 2023 (Anticipated)

Study Completion Date

May 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

HRS9531 injection compared with placebo and open positive-controlled group

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Arm Title

Group B

Arm Type

Experimental

Arm Description

Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Arm Title

Group C

Arm Type

Experimental

Arm Description

Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Arm Title

Group D

Arm Type

Active Comparator

Arm Description

Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

HRS9531

Intervention Description

Administrated SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administrated SC

Intervention Type

Drug

Intervention Name(s)

Dulaglutide Injection

Intervention Description

Administrated SC

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (Safety and Tolerability)

Description

A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events

Time Frame

Screening period up to Day 62

Secondary Outcome Measure Information:

Title

Area Under the Concentration Versus Time Curve (AUC) of HRS9531

Time Frame

Start of Treatment up to Day 62

Title

Maximum Concentration (Cmax) of HRS9531

Time Frame

Start of Treatment up to Day 62

Title

Change from Baseline in Fasting Blood Glucose (FBG)

Time Frame

Baseline up to Day 62

Title

Change from Baseline in Hemoglobin A1c (HbA1c)

Time Frame

Baseline up to Day 29

Title

Change from Baseline in Weight

Time Frame

Baseline up to Day 62

Title

Immunogenicity: anti-HRS9531 antibody

Time Frame

Start of Treatment up to Day 62

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hong Chen

Phone

0518-82342973

hong.chen@hengrui.com

Facility Information:

Facility Name

Zhongshan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoying Li

First Name & Middle Initial & Last Name & Degree

Xuening Li

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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