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Completed

NCT Number: NCT06536023

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Beijin, 100045, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

IBI362

Drug

IBI362 SA.QW

IBI362 placebo

Drug

IBI362 placebo SA.QW

Primary outcomes

  1. Incidence of adverse events and serious adverse events

    Time frame: up to week 20

Secondary outcomes

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

    Time frame: up to week 12

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

    Time frame: up to week 12

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

    Time frame: up to week 12

  4. Clearance (CL) of multi-dose of IBI362

    Time frame: up to week 12

  5. 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

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

    Time frame: up to week 12

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

    Time frame: up to week 12

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

    Time frame: up to week 12

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

    Time frame: up to week 12

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

    Time frame: up to week 20

  11. 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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.