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New drug IBI362 tested for teen obesity in first pediatric trial

NCT ID NCT06536023

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the safety and tolerability of a new drug called IBI362 in 36 Chinese adolescents aged 12 to 17 with obesity. Participants had not lost much weight through diet and exercise alone. The trial was randomized, double-blind, and placebo-controlled, meaning some got the drug and some got a dummy shot, and neither they nor the doctors knew who got what. The main goal was to check for side effects and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IBI362 (a drug for weight management)
What this could lead to
If successful, this could lead to a new weight-loss medication for teenagers with obesity.
What could go wrong
This is an early Phase 1 trial with only 36 participants, focused on safety and dosing. It is too small to prove effectiveness, and the drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

36 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescents with obesity

Contacts and locations

Locations

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

    Beijin, Beijin, 100045, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.