A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Phase 3RecruitingNCT07255209

Innovent Biologics (Suzhou) Co. Ltd.180 enrolled

Overview

The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and \<18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Interventions

PlaceboDRUG

Placebo SA.QW

IBI362DRUG

IBI362 SA.QW

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled: Key Inclusion Criteria： 1. Male or female participants aged ≥12 years and \<18 years at the time of signing the informed consent/assent form. 2. BMI at screening meeting the obesity criteria defined by "WS/T 586-2018 Screening for Overweight and Obesity in School-Age Children and Adolescents" or meeting overweight criteria plus at least one weight-related comorbidity: prediabetes, type 2 diabetes, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome. 3. Weight change \<5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report). Exclusion Criteria: Key Exclusion Criteria： 1. Prior diagnosis of type 1 diabetes. 2. Pre-pubertal participants (Tanner Stage I). 3. History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed \>1 year before screening).

Locations (1)

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Percent Change from Baseline in BMI

Time frame: Week 32

Secondary Outcomes

Percentage of Participants with ≥5% BMI Reduction

Time frame: Week 32

Percent Change from Baseline in BMI

Time frame: Week 52

Percentage of Participants with ≥5% BMI Reduction

Time frame: Week 52

Central Contacts

Xiaoyan li

CONTACT

18756032014 xiaoyan.li@innoventbio.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.