A Study of IBI362 in Participants With Obesity or Overweight

November 10, 2024 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Xuancheng, Anhui, China
        • Xuancheng People's Hospital
    • Beijing
      • Beijing, Beijing, China, 100044
        • People's Hospital of Peking University
    • Hebei
      • Langfang, Hebei, China
        • Hebei Petro China Central Hospital
    • Henan
      • Luoyang, Henan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Luoyang, Henan, China
        • Luoyang Third People's Hospital
      • Nanyang, Henan, China
        • The First Affiliated Hospital of Nanyang Medical University
      • Xinxiang, Henan, China
        • The Third Affiliated Hospital of Xinxiang Medical University
    • Jiangsu
      • Kunshan, Jiangsu, China
        • The First People's Hospital of Kunshan
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital
      • Nantong, Jiangsu, China
        • Affiliated Hospital of Nantong University
      • Suzhou, Jiangsu, China
        • Suzhou Municipal Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, China
        • Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, China
        • China-Japan Union Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shenyang Fifth People's Hospital
    • Shandong
      • Ji'nan, Shandong, China
        • Jinan Central Hospital
      • Ji'nan, Shandong, China
        • Shandong Provincial Third Hospital
      • Qingdao, Shandong, China
        • Qilu Hospital of Shandong University (QingDao)
      • Tai'an, Shandong, China
        • Tai'an Central Hospital
      • Zibo, Shandong, China
        • Zibo Municipal Hospital
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Bethune Hospital
      • Xianyang, Shanxi, China
        • Yan'an University Xianyang Hospital
    • Zhejiang
      • Huzhou, Zhejiang, China
        • Huzhou Central Hospital
      • Lishui, Zhejiang, China
        • Lishui Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.

Exclusion Criteria:

  • HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
  • Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening;
  • Have used or are currently using weight loss drugs within 3 months before screening;
  • History of pancreatitis;
  • Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
  • History of moderate to severe depression or severe mental illness;
  • Any lifetime history of a suicide attempt

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo,SC,once a week for 48 weeks
Drug: Placebo
Placebo administered subcutaneously (SC) once a week.
Experimental: IBI362 4 mg
2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks
Drug: IBI362
IBI362 administered subcutaneously (SC) once a week.
Experimental: IBI362 6 mg
2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks
Drug: IBI362
IBI362 administered subcutaneously (SC) once a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 32
Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time Frame: Week 32
Week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 48
Baseline, Week 48
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time Frame: Week 48
Week 48
Percentage of Participants who Achieve ≥10%Body Weight Reduction
Time Frame: Week 32,Week 48
Week 32,Week 48
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Time Frame: Week 32,Week 48
Week 32,Week 48
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 32,Week 48
Baseline, Week 32,Week 48
Percentage of Participants who Achieve ≥20% Body Weight Reduction
Time Frame: Week 32, Week 48
Week 32, Week 48
Change from Baseline in Neck Circumference
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Hip Circumference
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Body Weight
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 60
Baseline, Week 60
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Percentage of Participants with BMI < 24 kg/m2
Time Frame: Week 32, Week 48
Week 32, Week 48
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Diastolic Blood Pressure
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Low-density Lipoprotein Cholesterol
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in High-density Lipoprotein Cholesterol
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Serum Uric Acid
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Alanine Aminotransferase
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Aspartate Aminotransferase
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Glycated Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Fasting Plasma Glucose
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Fasting C-peptide
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in IWQoL-Lite-CT Questionnaire Scores
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in SF-36v2 Questionnaire Scores
Time Frame: Baseline, Week 32, Week 48
Baseline, Week 32, Week 48
Change from Baseline in Triglyceride
Time Frame: Baseline, Week 32,Week 48
Baseline, Week 32,Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIBI362B301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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