Clinical trial NCT06536023: This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Adolescents With Obesity
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events and serious adverse events
timeFrame: up to week 20
Secondary outcomes:
measure: Area under the Curve (AUC) of multi-dose of IBI362
timeFrame: up to week 12
measure: Half-life (t1/2) of multi-dose of IBI362
timeFrame: up to week 12
measure: Peak serum concentration (Cmax) of multi-dose of IBI362
timeFrame: up to week 12
measure: Clearance (CL) of multi-dose of IBI362
timeFrame: up to week 12
measure: Evaluate changes in subjects' fasting body weight in kilograms，Body Mass Index in kg/m2（BMI, combined with weight and height） relative to baseline
timeFrame: up to week 12
measure: Evaluate changes in subjects' waist-to-hip ratio（combined with waistline and hips） relative to baseline
timeFrame: up to week 12
measure: Evaluate changes in subjects' blood pressure in mmHg relative to baseline
timeFrame: up to week 12
measure: Evaluate changes in subjects' lipid profile in mmol/L relative to baseline
timeFrame: up to week 12
measure: Evaluate changes in subjects' glycated hemoglobin（Hemoglobin A1c,HbA1c）in % relative to baseline
timeFrame: up to week 12
measure: Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362.
timeFrame: up to week 20
measure: Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362.
timeFrame: up to week 20
Other outcomes:
Locations:
city: Beijin
country: China
facility: Beijing Children&#39;s Hospital, Capital Medical University Affiliated
state: Beijin
Study officials:
References: