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NCT06536023·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

36

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

IBI362

IBI362 SA.QW

DRUG

IBI362 placebo

IBI362 placebo SA.QW

Timeline

From registration to results.

  1. First posted

    Aug 2, 2024

  2. Study start

    Aug 30, 2024

  3. Primary completion

    Jul 22, 2025

  4. Study completion

    Aug 1, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Sep 12, 2025

Outcomes

What the study measures.

Primary outcomes

Incidence of adverse events and serious adverse events

Time frame · up to week 20

Secondary outcomes

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

Time frame · up to week 12

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

Time frame · up to week 12

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

Time frame · up to week 12

Clearance (CL) of multi-dose of IBI362

Time frame · 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

Time frame · up to week 12

Evaluate changes in subjects' waist-to-hip ratio(combined with waistline and hips) relative to baseline

Time frame · up to week 12

Evaluate changes in subjects' blood pressure in mmHg relative to baseline

Time frame · up to week 12

Evaluate changes in subjects' lipid profile in mmol/L relative to baseline

Time frame · up to week 12

Evaluate changes in subjects' glycated hemoglobin(Hemoglobin A1c,HbA1c)in % relative to baseline

Time frame · up to week 12

Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362.

Time frame · up to week 20

Eligibility

Who can take part.

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

Inclusion Criteria: 1. Male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent; 2. 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"; 3. 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); 4. Able to maintain a stable diet and exercise lifestyle during the study period; 5. 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. Exclusion Criteria: 1. Prepubertal subjects (Tanner Stage I) 2. Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies 3. Use of other weight-loss medications or treatments prior to screening 4. 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

Study locations

1 registered sites.

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

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

Beijin, Beijin, China

Publications

Results and literature.

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

Primary links

Continue at the source.

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