A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Innovent Biologics

Status and phase: Enrolling; Phase 3

Conditions: Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Treatments: Drug: IBI362; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07255209

CIBI362B304

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

IBI362-dose2

Experimental group

Treatment:

Drug: IBI362

IBI362-dose1

Experimental group

Treatment:

Drug: IBI362