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Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

Primary Purpose

Overweight or Obesity

Status
Not yet recruiting
Phase
Phase 2
Locations
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 Overweight or Obesity

Eligibility Criteria

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

Inclusion Criteria: Able and willing to provide a written informed consent. Male or female subjects, 18-65 years of age at the time of signing informed consent. 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months. Exclusion Criteria: Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit. poor-controlled hypertension. PHQ-9 score ≥15. Medical history of illness that affects weight. History of diabetes. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening. History of acute cardiovascular and cerebrovascular diseases. Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ. Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness. History of alcohol , medication or drug abuse within 1 year prior to screening. Use of any medication or treatment that may cause significant weight change within 3 months. History of bariatric surgery. Subjects participating in QT/QTc studies need to comply with relevant examinations. Known or suspected hypersensitivity to trial product(s) or related products. Participation in other clinical trials within 3 month prior to screening. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening Surgery is planned during the trial. Mentally incapacitated or speech-impaired. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members. In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    HRS9531 injection

    HRS9531 injection Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage change in body weight

    Secondary Outcome Measures

    Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment
    Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment
    Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment
    Change from baseline in body weight after 36 weeks of treatment
    Change from baseline in waist circumference after 36 weeks of treatment
    Change from baseline in BMI after 36 weeks of treatment
    Change from baseline in blood pressure after 36 weeks of treatment
    Change from baseline in total cholesterol after 36 weeks of treatment
    Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment
    Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment
    Number of AEs During the Trial

    Full Information

    First Posted
    September 19, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Fujian Shengdi Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06054698
    Brief Title
    Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects
    Official Title
    A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    September 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 assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HRS9531 injection
    Arm Type
    Experimental
    Arm Title
    HRS9531 injection Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    HRS9531 injection
    Intervention Description
    HRS9531 injection , QW,36 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    HRS9531 injection Placebo
    Intervention Description
    HRS9531 injection Placebo,QW,36 weeks
    Primary Outcome Measure Information:
    Title
    Percentage change in body weight
    Time Frame
    Week 0, Week 36
    Secondary Outcome Measure Information:
    Title
    Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment
    Time Frame
    Week 36
    Title
    Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment
    Time Frame
    Week 36
    Title
    Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment
    Time Frame
    Week 36
    Title
    Change from baseline in body weight after 36 weeks of treatment
    Time Frame
    Week 0, Week 36
    Title
    Change from baseline in waist circumference after 36 weeks of treatment
    Time Frame
    Week 0, Week 36
    Title
    Change from baseline in BMI after 36 weeks of treatment
    Time Frame
    Week 0, Week 36
    Title
    Change from baseline in blood pressure after 36 weeks of treatment
    Time Frame
    Week 0, Week 36
    Title
    Change from baseline in total cholesterol after 36 weeks of treatment
    Time Frame
    Week 0, Week 36
    Title
    Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment
    Time Frame
    Week 0, Week36
    Title
    Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment
    Time Frame
    Week 0, 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: Able and willing to provide a written informed consent. Male or female subjects, 18-65 years of age at the time of signing informed consent. 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months. Exclusion Criteria: Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit. poor-controlled hypertension. PHQ-9 score ≥15. Medical history of illness that affects weight. History of diabetes. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening. History of acute cardiovascular and cerebrovascular diseases. Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ. Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness. History of alcohol , medication or drug abuse within 1 year prior to screening. Use of any medication or treatment that may cause significant weight change within 3 months. History of bariatric surgery. Subjects participating in QT/QTc studies need to comply with relevant examinations. Known or suspected hypersensitivity to trial product(s) or related products. Participation in other clinical trials within 3 month prior to screening. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening Surgery is planned during the trial. Mentally incapacitated or speech-impaired. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members. In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hongcheng Hu
    Phone
    13672085298
    Email
    hongcheng.hu@hengrui.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junmeng Shi
    Phone
    17721288226
    Email
    Junmeng.shi.js12@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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