GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

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

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 586-2018

Primary endpoint

•Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06536023

Org study IDCIBI362B103

Timeline

Milestones

Study first posted2024-08-02actual

Study start2024-08-30actual

Primary completion2025-07-22actual

Study completion2025-08-01actual

Last update posted2025-09-12actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

2 endpoints

Secondary/protocol endpoint

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

change from baseline, improvement

componentsBody weight, absolute change (kg), BMI, change

Secondary/protocol endpoint

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

Time frame:up to week 12

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

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

Time frame:up to week 12

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

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

Time frame:up to week 12

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:up to week 12

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

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

Time frame:up to week 20

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Incidence of adverse events and serious adverse events

Time frame:up to week 20

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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

Time frame:up to week 12

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:up to week 12

Half-life

descriptive

Secondary/protocol endpoint

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

Time frame:up to week 12

Cmax

concentration, descriptive

Secondary/protocol endpoint

Clearance (CL) of multi-dose of IBI362

Time frame:up to week 12

descriptive

Secondary/protocol endpoint

Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362.

Time frame:up to week 20

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.