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)
1 other identifier
interventional
610
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2022
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2022
CompletedFirst Posted
Study publicly available on registry
November 7, 2022
CompletedStudy Start
First participant enrolled
November 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2024
CompletedNovember 12, 2024
November 1, 2024
9 months
October 23, 2022
November 10, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change from Baseline in Body Weight
Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Week 32
Secondary Outcomes (28)
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
Percent Change from Baseline in Body Weight
Baseline, Week 48
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Week 48
- +23 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo,SC,once a week for 48 weeks
IBI362 4 mg
EXPERIMENTAL2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks
IBI362 6 mg
EXPERIMENTAL2 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Xuancheng People's Hospital
Xuancheng, Anhui, China
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044, China
Luoyang Third People's Hospital
Luoyang, He'nan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, He'nan, China
The First Affiliated Hospital of Nanyang Medical University
Nanyang, He'nan, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, He'nan, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
The First People's Hospital Of Kunshan
Kunshan, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Affiliated Hospital Of Nantong University
Nantong, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Shenyang Fifth People's Hospital
Shenyang, Liaoning, China
Jinan Central Hospital
Ji'nan, Shandong, China
Shandong Provincial Third Hospital
Ji'nan, Shandong, China
Qilu Hospital Of Shandong University (Qingdao)
Qingdao, Shandong, China
Tai'an Central Hospital
Tai’an, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Yan'an University Xianyang Hospital
Xianyang, Shanxi, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
Related Publications (1)
Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.
PMID: 40421736DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2022
First Posted
November 7, 2022
Study Start
November 14, 2022
Primary Completion
August 21, 2023
Study Completion
April 16, 2024
Last Updated
November 12, 2024
Record last verified: 2024-11