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Trial · Interventional

RecruitingPhase 3Registry data

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

NCTNCT07255209 (opens ClinicalTrials.gov in a new tab)Other idCIBI362B304
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
180 participants (estimated)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
29 Dec 2025
Primary completion
31 Oct 2027 (estimated)
Completion
31 Oct 2028 (estimated)
First posted
28 Nov 2025
Last update posted
8 Jan 2026
Conditions
Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 3

    A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

    NCT07255209

    29 Dec 2025 to est. 31 Oct 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • PlaceboDrug
  • IBI362Drug

Arms3

  • Placebo comparator

    Placebo

  • Experimental

    IBI362-dose2

  • Experimental

    IBI362-dose1

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in BMI

    Time frame · Week 32

Secondary outcomes(3)

  1. Percentage of Participants with ≥5% BMI Reduction

    Time frame · Week 32

  2. Percent Change from Baseline in BMI

    Time frame · Week 52

  3. Percentage of Participants with ≥5% BMI Reduction

    Time frame · Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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