A Study of IBI362 in Participants With Obesity or Overweight
- Registration Number
- NCT05607680
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 610
• 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo,SC,once a week for 48 weeks IBI362 4 mg IBI362 2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks IBI362 6 mg IBI362 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
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 32 Percentage of Participants who Achieve ≥5% Body Weight Reduction Week 32
- Secondary Outcome Measures
Name Time Method 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 60 Percentage of Participants who Achieve ≥5% Body Weight Reduction 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 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 Triglyceride 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
Trial Locations
- Locations (23)
Xuancheng People's Hospital
🇨🇳Xuancheng, Anhui, China
Hebei Petro China Central Hospital
🇨🇳Langfang, Hebei, China
Luoyang Third People's Hospital
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical University
🇨🇳Nanyang, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, 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
People's Hospital of Peking University
🇨🇳Beijing, Beijing, China