NCT07255209

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
31mo left

Started Dec 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Dec 2025Oct 2028

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 29, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

November 19, 2025

Last Update Submit

January 7, 2026

Conditions

Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in BMI

    Week 32

Secondary Outcomes (3)

  • Percentage of Participants with ≥5% BMI Reduction

    Week 32

  • Percent Change from Baseline in BMI

    Week 52

  • Percentage of Participants with ≥5% BMI Reduction

    Week 52

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

IBI362-dose2

EXPERIMENTAL
Drug: IBI362

IBI362-dose1

EXPERIMENTAL
Drug: IBI362

Interventions

PlaceboDRUG

Placebo SA.QW

Placebo
IBI362DRUG

IBI362 SA.QW

IBI362-dose1IBI362-dose2

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female participants aged ≥12 years and \<18 years at the time of signing the informed consent/assent form.
  • 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.
  • Weight change \<5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).

You may not qualify if:

  • Prior diagnosis of type 1 diabetes.
  • Pre-pubertal participants (Tanner Stage I).
  • History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed \>1 year before screening).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

MeSH Terms

Interventions

mazdutide

Central Study Contacts

Xiaoyan li

CONTACT

18756032014xiaoyan.li@innoventbio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

December 29, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

CN(1)