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A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HRS-7535
Placebo
Sponsored by
Shandong Suncadia Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, 18-75 age years, both inclusive; Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis; Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive); Exclusion Criteria: Known or suspected allergy to the investigational drug or its components or excipients. 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.) within 6 months prior to screening. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 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. Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons. Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy). Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Group E

    Arm Description

    Subjects will receive HRS-7535 administered orally

    Subjects will receive HRS-7535 administered orally

    Subjects will receive escalated dose of HRS-7535 administered orally

    Subjects will receive escalated HRS-7535 administered orally

    Subjects will receive Placebo administered orally

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline in HbA1c at Week 16

    Secondary Outcome Measures

    Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16
    Change From Baseline in fasting plasma glucose (FPG) at Week 16
    Change From Baseline in Mixed meal test at Week 16
    Change From Baseline in body weight at Week 16
    Change From Baseline in waist circumference at Week 16
    Change From Baseline in 7-point SMBG at Week 16
    Proportion of subjects receiving glycemic rescue medicine at Week 16
    A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[

    Full Information

    First Posted
    February 9, 2023
    Last Updated
    February 26, 2023
    Sponsor
    Shandong Suncadia Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05759897
    Brief Title
    A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus
    Official Title
    A 16-week Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 28, 2023 (Anticipated)
    Primary Completion Date
    December 21, 2023 (Anticipated)
    Study Completion Date
    January 4, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shandong Suncadia Medicine 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
    The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.

    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
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    HRS-7535 tablet compared with placebo
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Subjects will receive HRS-7535 administered orally
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Subjects will receive HRS-7535 administered orally
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Subjects will receive escalated dose of HRS-7535 administered orally
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    Subjects will receive escalated HRS-7535 administered orally
    Arm Title
    Group E
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive Placebo administered orally
    Intervention Type
    Drug
    Intervention Name(s)
    HRS-7535
    Intervention Description
    HRS-7535
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in HbA1c at Week 16
    Time Frame
    at Week 16]
    Secondary Outcome Measure Information:
    Title
    Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16
    Time Frame
    at Week 16
    Title
    Change From Baseline in fasting plasma glucose (FPG) at Week 16
    Time Frame
    at Week 16
    Title
    Change From Baseline in Mixed meal test at Week 16
    Time Frame
    at Week 16
    Title
    Change From Baseline in body weight at Week 16
    Time Frame
    at Week 16
    Title
    Change From Baseline in waist circumference at Week 16
    Time Frame
    at Week 16
    Title
    Change From Baseline in 7-point SMBG at Week 16
    Time Frame
    at Week 16
    Title
    Proportion of subjects receiving glycemic rescue medicine at Week 16
    Time Frame
    at Week 16
    Title
    A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[
    Time Frame
    at Week 18

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, 18-75 age years, both inclusive; Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis; Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive); Exclusion Criteria: Known or suspected allergy to the investigational drug or its components or excipients. 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.) within 6 months prior to screening. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 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. Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons. Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy). Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yimei Xu
    Phone
    0518-82342973
    Email
    yimei.xu@hengrui.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shujin Cheng
    Phone
    0518-82342973
    Email
    shujin.cheng@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

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