NCT06536023CompletedPhase 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
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 25 Jul 2024
- Start date
- 30 Aug 2024
- Primary completion date
- 22 Jul 2025
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Obesity
- NCT number
- NCT06536023
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 30 Aug 2024 to the primary completion date, 22 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other weight-loss medications or treatments prior to screening
Other illness
- Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies
Lab values
- 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
Other
- Prepubertal subjects (Tanner Stage I)
Who the study is looking for
- 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.
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University Affiliated Coordinator of this site? Confirm its status | Beijin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.