Clinical trial NCT05607680: A Study of IBI362 in Participants With Obesity or Overweight
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity Or Overweight
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 32
measure: Percentage of Participants who Achieve ≥5% Body Weight Reduction
timeFrame: Week 32
Secondary outcomes:
measure: Percentage of Participants who Achieve ≥10%Body Weight Reduction
timeFrame: Week 32,Week 48
measure: Percentage of Participants who Achieve ≥15% Body Weight Reduction
timeFrame: Week 32,Week 48
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 32,Week 48
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
measure: Percentage of Participants who Achieve ≥5% Body Weight Reduction
timeFrame: Week 48
measure: Percentage of Participants who Achieve ≥20% Body Weight Reduction
timeFrame: Week 32, Week 48
measure: Change from Baseline in Neck Circumference
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Hip Circumference
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 32, Week 48
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 60
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 32, Week 48
measure: Percentage of Participants with BMI < 24 kg/m2
timeFrame: Week 32, Week 48
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Diastolic Blood Pressure
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Triglyceride
timeFrame: Baseline, Week 32,Week 48
measure: Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Low-density Lipoprotein Cholesterol
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in High-density Lipoprotein Cholesterol
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Serum Uric Acid
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Alanine Aminotransferase
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Aspartate Aminotransferase
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Glycated Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Fasting Plasma Glucose
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Fasting C-peptide
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR)
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in IWQoL-Lite-CT Questionnaire Scores
timeFrame: Baseline, Week 32, Week 48
measure: Change from Baseline in SF-36v2 Questionnaire Scores
timeFrame: Baseline, Week 32, Week 48
Other outcomes:
Locations:
city: Xuancheng
country: China
facility: Xuancheng People's Hospital
state: Anhui
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
state: Hebei
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical University
state: Henan
city: Xinxiang
country: China
facility: The Third Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Kunshan
country: China
facility: The First People's Hospital Of Kunshan
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital Of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shenyang Fifth People's Hospital
state: Liaoning
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Ji'nan
country: China
facility: Shandong Provincial Third Hospital
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital Of Shandong University (Qingdao)
state: Shandong
city: Tai'an
country: China
facility: Tai'an Central Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Municipal Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xianyang
country: China
facility: Yan'an University Xianyang Hospital
state: Shanxi
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
Study officials:
References: