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Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HRS9531 injection
HRS9531 injection Placebo
Sponsored by
Fujian Shengdi Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

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

Inclusion Criteria: Male or female subjects ,18-65 years of age, agreed and signed the informed consent Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. HbA1c 7.5-10.5% (both inclusive) at screening visit. Exclusion Criteria: Presence of any clinically significant results in examination at screening visit. Uncontrollable hypertension. A history of type 1 diabetes, specific diabetes, or secondary diabetes. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness. Surgery is planned during the trial. Mentally incapacitated or speech-impaired. Pregnant or lactating woman. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Sites / Locations

  • Shandong Provincial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Treatment group C

Treatment group D

Treatment group E

Treatment group F

Treatment group G

Treatment group H

Arm Description

HRS9531 injection dose level 1

HRS9531 injection dose level 2

HRS9531 injection dose level 3

HRS9531 injection dose level 4

HRS9531 injection Placebo dose level 1

HRS9531 injection Placebo dose level 2

HRS9531 injection Placebo dose level 3

HRS9531 injection Placebo dose level 4

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c after 20 weeks of treatment

Secondary Outcome Measures

Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
Change From Baseline in HbA1c after 32 weeks
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
Change from baseline body Weight and waist circumference after 20 weeks of treatment
Change from baseline in body Weight and waist circumference after 32 weeks of treatment
Number of Participants With Anti-HRS9531 Antibody
Number of AEs During the Trial

Full Information

First Posted
July 21, 2023
Last Updated
August 30, 2023
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05966272
Brief Title
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Official Title
A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
August 12, 2024 (Anticipated)
Study Completion Date
September 9, 2024 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes 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
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
HRS9531 injection dose level 1
Arm Title
Treatment group B
Arm Type
Experimental
Arm Description
HRS9531 injection dose level 2
Arm Title
Treatment group C
Arm Type
Experimental
Arm Description
HRS9531 injection dose level 3
Arm Title
Treatment group D
Arm Type
Experimental
Arm Description
HRS9531 injection dose level 4
Arm Title
Treatment group E
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo dose level 1
Arm Title
Treatment group F
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo dose level 2
Arm Title
Treatment group G
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo dose level 3
Arm Title
Treatment group H
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo dose level 4
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection Placebo
Intervention Description
single dose
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c after 20 weeks of treatment
Time Frame
Week 0 to Week 20
Secondary Outcome Measure Information:
Title
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
Time Frame
Week 0 to Week 20
Title
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
Time Frame
Week 0 to Week 32
Title
Change From Baseline in HbA1c after 32 weeks
Time Frame
Week 0 to Week 32
Title
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
Time Frame
Week 0 to Week 20
Title
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
Time Frame
Week 0 to Week 32
Title
Change from baseline body Weight and waist circumference after 20 weeks of treatment
Time Frame
Week 0 to Week 20
Title
Change from baseline in body Weight and waist circumference after 32 weeks of treatment
Time Frame
Week 0 to Week 32
Title
Number of Participants With Anti-HRS9531 Antibody
Time Frame
Week 0 to Week 36
Title
Number of AEs During the Trial
Time Frame
Week 0 to Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects ,18-65 years of age, agreed and signed the informed consent Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. HbA1c 7.5-10.5% (both inclusive) at screening visit. Exclusion Criteria: Presence of any clinically significant results in examination at screening visit. Uncontrollable hypertension. A history of type 1 diabetes, specific diabetes, or secondary diabetes. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness. Surgery is planned during the trial. Mentally incapacitated or speech-impaired. Pregnant or lactating woman. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongcheng Hu
Phone
0518-82342973
Email
hongcheng.hu@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianting Han
Phone
0518-82342973
Email
jianting.han.jh27@hengrui.com
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiajun Zhao, Doctor
Phone
+86-0531-87938911
Email
jjzhao@sdu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

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