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NCT07255209·Phase 3·INTERVENTIONAL

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

MazdutideWeight lossRecruiting

Status

Recruiting

Phase

Phase 3

Enrollment

180

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Placebo

Placebo SA.QW

DRUG

IBI362

IBI362 SA.QW

Timeline

From registration to results.

  1. First posted

    Nov 28, 2025

  2. Study start

    Dec 29, 2025

  3. Primary completion

    Oct 31, 2027

  4. Study completion

    Oct 31, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jan 8, 2026

Outcomes

What the study measures.

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

Eligibility

Who can take part.

Minimum age
12 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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).

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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