DRUG
IBI362
IBI362 SA.QW
Status
Completed
Phase
Phase 1
Enrollment
36
Locations
1
Results
Not posted
Publications
0
Study summary
The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and \<18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.
Interventions
DRUG
IBI362 SA.QW
DRUG
IBI362 placebo SA.QW
Timeline
First posted
Aug 2, 2024
Study start
Aug 30, 2024
Primary completion
Jul 22, 2025
Study completion
Aug 1, 2025
Results posted
Not reported
Registry updated
Sep 12, 2025
Outcomes
Incidence of adverse events and serious adverse events
Time frame · up to week 20
Area under the Curve (AUC) of multi-dose of IBI362
Time frame · up to week 12
Half-life (t1/2) of multi-dose of IBI362
Time frame · up to week 12
Peak serum concentration (Cmax) of multi-dose of IBI362
Time frame · up to week 12
Clearance (CL) of multi-dose of IBI362
Time frame · up to week 12
Evaluate changes in subjects' fasting body weight in kilograms,Body Mass Index in kg/m2(BMI, combined with weight and height) relative to baseline
Time frame · up to week 12
Evaluate changes in subjects' waist-to-hip ratio(combined with waistline and hips) relative to baseline
Time frame · up to week 12
Evaluate changes in subjects' blood pressure in mmHg relative to baseline
Time frame · up to week 12
Evaluate changes in subjects' lipid profile in mmol/L relative to baseline
Time frame · up to week 12
Evaluate changes in subjects' glycated hemoglobin(Hemoglobin A1c,HbA1c)in % relative to baseline
Time frame · up to week 12
Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362.
Time frame · up to week 20
Eligibility
Inclusion Criteria: 1. Male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent; 2. At screening, the Body Mass Index (BMI) meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents"; 3. Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian); 4. Able to maintain a stable diet and exercise lifestyle during the study period; 5. Capable of understanding the procedures and methods of this study, willing to strictly adhere to the clinical trial protocol to complete this trial, with both the subject and the parent or legal guardian voluntarily signing the informed consent form. Exclusion Criteria: 1. Prepubertal subjects (Tanner Stage I) 2. Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies 3. Use of other weight-loss medications or treatments prior to screening 4. Evidence or history of other medical conditions prior to screening: * HbA1c ≥ 6.5% at screening or a previous diagnosis of Type 1 or Type 2 diabetes * Presence of retinopathy at screening * History of severe hypoglycemia or recurrent symptomatic hypoglycemia * Obesity secondary to disease or medication, including hypercortisolism (e.g., Cushing's syndrome) * Previous bariatric surgery * History of moderate to severe depression; or history of serious psychiatric illness * Previous suicidal ideation or suicide attempt
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Beijing Children's Hospital, Capital Medical University Affiliated
Beijin, Beijin, China
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
West China Hospital · Metabolic Dysfunction-Associated Steatohepatitis · Hepatic Steatosis
Phase 2 / Phase 3
Not yet recruiting
60
2026-07
Eli Lilly · Obesity · Overweight
Phase 2
Recruiting
1,481
2026-07
Tianjin Medical University · Type 2 Diabetes Mellitus (T2DM) · Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
Not applicable
Not yet recruiting
72
2026-07
Eli Lilly · Alcohol Use Disorder
Phase 2
Completed
308
2026-07
China National Center for Cardiovascular Diseases · Obesity & Overweight · Coronary Heart Disease
Phase 4
Not yet recruiting
116
2026-06
Shandong Provincial Hospital · Prediabetes · Impaired Fasting Glucose
Phase 4
Not yet recruiting
150
2026-06
Innovent Biologics (Suzhou) Co. Ltd. · Type 2 Diabetes · Obesity
Phase 3
Completed
349
2026-06
China-Japan Friendship Hospital · Obesity
Not applicable
Recruiting
200
2026-06
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.