Adolescents With ObesityPhase 1NCT06536023
This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity
A Phase 1 study testing IBI362 in people with Adolescents With Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescents With Obesity
- What is being tested?
- IBI362
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 1 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Children's Hospital, Capital Medical University Affiliated
Beijin, Beijin, 100045
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects
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.
- Conditions
- Adolescents With Obesity
- Being tested
- IBI362, IBI362 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI362Drug
IBI362 SA.QW
IBI362 placeboDrug
IBI362 placebo SA.QW
| Study group | Role | What they receive |
|---|---|---|
| 362-dose1-4mg | Experimental | The starting dose for the subjects is 2 mg, administered once weekly for 4 consecutive weeks. If the subject shows good tolerability, the dose will then be escalated to 4 mg, also given once weekly, for another 8 weeks (with an escalation rate of increasing 2 mg every 4 weeks until reaching the target dose). Receives: Drug: IBI362 |
| 362-dose2-6mg | Experimental | Subjects start at a dose of 2 mg, administered once weekly for 4 consecutive weeks. Following this, if the subject demonstrates good tolerability#, the dose will be escalated to 4 mg, also administered once weekly, for another 4 weeks. After observing the subject's tolerability again, if it remains favorable#, the dose will be further escalated to 6 mg, administered once weekly, for another 4 weeks (dosing will increase by 2 mg every 4 weeks until reaching the target dose of 6 mg) Receives: Drug: IBI362 |
| 362-dose3-Placebo | Experimental | Administration is via subcutaneous injection once weekly; the mode and form of placebo administration are consistent with those of IBI362, with continuous dosing over a 12-week period. Receives: Drug: IBI362 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events
Measured: up to week 20
Secondary outcomes (11)
Area under the Curve (AUC) of multi-dose of IBI362
Measured: up to week 12
Half-life (t1/2) of multi-dose of IBI362
Measured: up to week 12
Peak serum concentration (Cmax) of multi-dose of IBI362
Measured: up to week 12
Clearance (CL) of multi-dose of IBI362
Measured: up to week 12
Evaluate changes in subjects' fasting body weight in kilograms，Body Mass Index in kg/m2（BMI, combined with weight and height） relative to baseline
Measured: up to week 12
Evaluate changes in subjects' waist-to-hip ratio（combined with waistline and hips） relative to baseline
Measured: up to week 12
Evaluate changes in subjects' blood pressure in mmHg relative to baseline
Measured: up to week 12
Evaluate changes in subjects' lipid profile in mmol/L relative to baseline
Measured: up to week 12
Evaluate changes in subjects' glycated hemoglobin（Hemoglobin A1c,HbA1c）in % relative to baseline
Measured: up to week 12
Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362.
Measured: up to week 20
Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362.
Measured: up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start30 Aug 2024
- Primary completion22 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescents With ObesityStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536023
- Sponsor's protocol ID
- CIBI362B103
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects
- ClinicalTrials.gov ID
- NCT06536023
- Acronym / sponsor ID
- CIBI362B103
- Conditions
- Adolescents With Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 362-dose1-4mg | Experimental | Drug: IBI362The starting dose for the subjects is 2 mg, administered once weekly for 4 consecutive weeks. If the subject shows good tolerability, the dose will then be escalated to 4 mg, also given once weekly, for another 8 weeks (with an escalation rate of increasing 2 mg every 4 weeks until reaching the target dose). |
| 362-dose2-6mg | Experimental | Drug: IBI362Subjects start at a dose of 2 mg, administered once weekly for 4 consecutive weeks. Following this, if the subject demonstrates good tolerability#, the dose will be escalated to 4 mg, also administered once weekly, for another 4 weeks. After observing the subject's tolerability again, if it remains favorable#, the dose will be further escalated to 6 mg, administered once weekly, for another 4 weeks (dosing will increase by 2 mg every 4 weeks until reaching the target dose of 6 mg) |
| 362-dose3-Placebo | Experimental | Drug: IBI362 placeboAdministration is via subcutaneous injection once weekly; the mode and form of placebo administration are consistent with those of IBI362, with continuous dosing over a 12-week period. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI362IBI362 SA.QW | Drug | 362-dose1-4mg, 362-dose2-6mg |
| IBI362 placeboIBI362 placebo SA.QW | Drug | 362-dose3-Placebo |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: up to week 20
11 secondary outcomes
Area under the Curve (AUC) of multi-dose of IBI362
Time frame: up to week 12
Half-life (t1/2) of multi-dose of IBI362
Time frame: up to week 12
Peak serum concentration (Cmax) of multi-dose of IBI362
Time frame: up to week 12
Clearance (CL) of multi-dose of IBI362
Time frame: up to week 12
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
Evaluate changes in subjects' waist-to-hip ratio（combined with waistline and hips） relative to baseline
Time frame: up to week 12
Evaluate changes in subjects' blood pressure in mmHg relative to baseline
Time frame: up to week 12
Evaluate changes in subjects' lipid profile in mmol/L relative to baseline
Time frame: up to week 12
Evaluate changes in subjects' glycated hemoglobin（Hemoglobin A1c,HbA1c）in % relative to baseline
Time frame: up to week 12
Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362.
Time frame: up to week 20
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI362 in people with Adolescents With Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: up to week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.