This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

NCT06536023 | Completed Phase 1

• 1 other identifier: CIBI362B103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and \<18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.

Conditions

Adolescents With Obesity

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and serious adverse events

  up to week 20

Secondary Outcomes (11)

• Area under the Curve (AUC) of multi-dose of IBI362

  up to week 12

• Half-life (t1/2) of multi-dose of IBI362

  up to week 12

• Peak serum concentration (Cmax) of multi-dose of IBI362

  up to week 12

• Clearance (CL) of multi-dose of IBI362

  up to week 12

• Evaluate changes in subjects' fasting body weight in kilograms，Body Mass Index in kg/m2（BMI, combined with weight and height） relative to baseline

  up to week 12

Study Arms (3)

362-dose1-4mg

EXPERIMENTAL

The starting dose for the subjects is 2 mg, administered once weekly for 4 consecutive weeks. If the subject shows good tolerability, the dose will then be escalated to 4 mg, also given once weekly, for another 8 weeks (with an escalation rate of increasing 2 mg every 4 weeks until reaching the target dose).

Drug: IBI362

362-dose2-6mg

EXPERIMENTAL

Subjects start at a dose of 2 mg, administered once weekly for 4 consecutive weeks. Following this, if the subject demonstrates good tolerability#, the dose will be escalated to 4 mg, also administered once weekly, for another 4 weeks. After observing the subject's tolerability again, if it remains favorable#, the dose will be further escalated to 6 mg, administered once weekly, for another 4 weeks (dosing will increase by 2 mg every 4 weeks until reaching the target dose of 6 mg)

Drug: IBI362

362-dose3-Placebo

EXPERIMENTAL

Administration is via subcutaneous injection once weekly; the mode and form of placebo administration are consistent with those of IBI362, with continuous dosing over a 12-week period.

Drug: IBI362 placebo

Interventions

IBI362 DRUG

IBI362 SA.QW

362-dose1-4mg; 362-dose2-6mg

IBI362 placebo DRUG

IBI362 placebo SA.QW

362-dose3-Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent;
• At screening, the Body Mass Index (BMI) meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
• Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
• Able to maintain a stable diet and exercise lifestyle during the study period;
• Capable of understanding the procedures and methods of this study, willing to strictly adhere to the clinical trial protocol to complete this trial, with both the subject and the parent or legal guardian voluntarily signing the informed consent form.

You may not qualify if:

• Prepubertal subjects (Tanner Stage I)
• Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies
• Use of other weight-loss medications or treatments prior to screening
• Evidence or history of other medical conditions prior to screening:
• HbA1c ≥ 6.5% at screening or a previous diagnosis of Type 1 or Type 2 diabetes
• Presence of retinopathy at screening
• History of severe hypoglycemia or recurrent symptomatic hypoglycemia
• Obesity secondary to disease or medication, including hypercortisolism (e.g., Cushing's syndrome)
• Previous bariatric surgery
• History of moderate to severe depression; or history of serious psychiatric illness
• Previous suicidal ideation or suicide attempt

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Beijing Children&#39;s Hospital, Capital Medical University Affiliated

Beijin, Beijin, 100045, China

Location

MeSH Terms

Interventions

mazdutide

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 2, 2024
• Study Start: August 30, 2024
• Primary Completion: July 22, 2025
• Study Completion: August 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)