DRUG
Placebo
Placebo administered subcutaneously (SC) once a week.
A Study of IBI362 in Participants With Obesity or Overweight
Status
Completed
Phase
Phase 3
Enrollment
610
Locations
23
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
IBI362
IBI362 administered subcutaneously (SC) once a week.
Timeline
From registration to results.
First posted
Nov 7, 2022
Study start
Nov 14, 2022
Primary completion
Aug 21, 2023
Study completion
Apr 16, 2024
Results posted
Not reported
Registry updated
Nov 12, 2024
Outcomes
What the study measures.
Primary outcomes
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 32
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time frame · Week 32
Secondary outcomes
Percentage of Participants who Achieve ≥10%Body Weight Reduction
Time frame · Week 32,Week 48
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Time frame · Week 32,Week 48
Change from Baseline in Waist Circumference
Time frame · Baseline, Week 32,Week 48
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 48
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time frame · Week 48
Percentage of Participants who Achieve ≥20% Body Weight Reduction
Time frame · Week 32, Week 48
Change from Baseline in Neck Circumference
Time frame · Baseline, Week 32, Week 48
Change from Baseline in Hip Circumference
Time frame · Baseline, Week 32, Week 48
Change from Baseline in Body Weight
Time frame · Baseline, Week 32, Week 48
Percent Change from Baseline in Body Weight
Time frame · Baseline, Week 60
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
23 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Xuancheng People's Hospital
Xuancheng, Anhui, China
People's Hospital of Peking University
Beijing, Beijing Municipality, 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
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