A Study of IBI362 in Participants With Obesity or Overweight

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: Completed
• Conditions: Obesity Or Overweight
• Intervention / Treatment: Drug: IBI362; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 610
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Percent Change from Baseline in Body Weight	Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction	Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Body Weight	Baseline, Week 48
Percentage of Participants who Achieve ≥5% Body Weight Reduction	Week 48
Percentage of Participants who Achieve ≥10%Body Weight Reduction	Week 32,Week 48
Percentage of Participants who Achieve ≥15% Body Weight Reduction	Week 32,Week 48
Change from Baseline in Waist Circumference	Baseline, Week 32,Week 48
Percentage of Participants who Achieve ≥20% Body Weight Reduction	Week 32, Week 48
Change from Baseline in Neck Circumference	Baseline, Week 32, Week 48
Change from Baseline in Hip Circumference	Baseline, Week 32, Week 48
Change from Baseline in Body Weight	Baseline, Week 32, Week 48
Percent Change from Baseline in Body Weight	Baseline, Week 60
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 32, Week 48
Percentage of Participants with BMI < 24 kg/m2	Week 32, Week 48
Change from Baseline in Systolic Blood Pressure	Baseline, Week 32, Week 48
Change from Baseline in Diastolic Blood Pressure	Baseline, Week 32, Week 48
Change from Baseline in Total Cholesterol	Baseline, Week 32, Week 48
Change from Baseline in Low-density Lipoprotein Cholesterol	Baseline, Week 32, Week 48
Change from Baseline in High-density Lipoprotein Cholesterol	Baseline, Week 32, Week 48
Change from Baseline in Serum Uric Acid	Baseline, Week 32, Week 48
Change from Baseline in Alanine Aminotransferase	Baseline, Week 32, Week 48
Change from Baseline in Aspartate Aminotransferase	Baseline, Week 32, Week 48
Change from Baseline in Glycated Hemoglobin A1c (HbA1c)	Baseline, Week 32, Week 48
Change from Baseline in Fasting Plasma Glucose	Baseline, Week 32, Week 48
Change from Baseline in Fasting Insulin	Baseline, Week 32, Week 48
Change from Baseline in Fasting C-peptide	Baseline, Week 32, Week 48
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)	Baseline, Week 32, Week 48
Change from Baseline in IWQoL-Lite-CT Questionnaire Scores	Baseline, Week 32, Week 48
Change from Baseline in SF-36v2 Questionnaire Scores	Baseline, Week 32, Week 48
Change from Baseline in Triglyceride	Baseline, Week 32,Week 48

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): August 21, 2023
• Study Completion (Actual): April 16, 2024

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID 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