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Overweight/ ObesityPhase 2NCT04904913

A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

A Phase 2 study testing IBI362 in people with Overweight/ Obesity, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Overweight/ 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
328 participants
Where
1 siteChina
Study dates
8 Jun 2021to 6 Dec 2023
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The first stage: Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² with at least one of the following comorbidities: hyperphagia, pre-diabetes, hypertension, dyslipidemia, fatty liver disease, weight-bearing joint pain, obesity-induced dyspnea or obstructive sleep apnea syndrome; The second stage: Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²)
  • The weight change of the subjects before and after the introduction period was less than 5.0%

Who cannot join

  • Diabetes mellitus
  • Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening
  • Have used or are currently using weight loss drugs within 3 months before screening
  • History of pancreatitis
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • History of moderate to severe depression，or have a history of serious mental illness
  • Any lifetime history of a suicide attempt

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University people's hospital

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects

This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other.

In the first stage of this study, about 240 subjects will be enrolled. Qualified subjects will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 low dose, IBI362 moderate dose, IBI362 high dose groups, in every group, subjects will be randomized to IBI362 and placebo groups at a ratio of 3:1. Random stratification is performed based on BMI < 28.0 kg/㎡ and BMI≥28.0 kg/㎡. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a-24 week double-blind treatment period, and a 12-week drug discontinuation follow-up period. During the entire research period, the subjects shall maintain diet and exercise control.

The second stage is IBI362 extra high dose study, about 80 subjects will be enrolled. Qualified participants will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 extra high dose and placebo groups at a ratio of 3:1. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a 24-week double-blind treatment period, a 24-week extended treatment period, and a 12-week drug discontinuation follow-up period. The 24-week extended treatment period is optional. During the entire research period, the subjects shall maintain diet and exercise control.

Being tested
IBI362, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI362Drug

    IBI362 administered subcutaneously (SC) once a week.

  • placeboOther

    placebo administered subcutaneously (SC) once a week.

Study groups in NCT04904913
Study groupRoleWhat they receive
IBI362 high doseExperimentalhigh dose IBI362 administered subcutaneously (SC) once a week.
Receives: Drug: IBI362
IBI362 low doseExperimentalLow dose IBI362 administered subcutaneously (SC) once a week.
Receives: Drug: IBI362
placeboPlacebo comparatorplacebo administered subcutaneously (SC) once a week.
Receives: Other: placebo
IBI362 moderate doseExperimentalmoderate dose IBI362 administered subcutaneously (SC) once a week.
Receives: Drug: IBI362
IBI362 extra high doseExperimentalextra high dose IBI362 administered subcutaneously (SC) once a week.
Receives: Drug: IBI362

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Weight

    Percent Change from Baseline in Body Weight

    Measured: Baseline ,week 24

Secondary outcomes (15)

  1. Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Measured: Baseline, Week 24

  2. Percentage of Participants who Achieve ≥10% Body Weight Reduction

    Measured: Baseline, Week 24

  3. Absolute change from Baseline in body weight

    Measured: Baseline, Week 24

  4. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 24

  5. Change from Baseline in BMI

    Measured: Baseline, Week 24

  6. Change from Baseline in HbA1c

    Measured: Baseline, Week 24

  7. Change from Baseline in fasting plasma glucose

    Measured: Baseline, Week 24

  8. Change from Baseline in systolic blood pressure

    Measured: Baseline, Week 24

  9. Change from Baseline in diastolic blood pressure

    Measured: Baseline, Week 24

  10. Change from Baseline in total cholesterol

    Measured: Baseline, Week 24

  11. Change from Baseline in low-density lipoprotein cholesterol

    Measured: Baseline, Week 24

  12. Change from Baseline in high-density lipoprotein cholesterol

    Measured: Baseline, Week 24

  13. Change from Baseline in triglyceride

    Measured: Baseline, Week 24

  14. Change from Baseline in serum uric acid

    Measured: Baseline, Week 12, Week 24

  15. Change from Baseline in IWQoL-Lite-CT questionnaire scores

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start8 Jun 2021
  3. Primary completion29 Mar 2023
  4. Study completion6 Dec 2023

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04904913
Sponsor's protocol ID
CIBI362B201
Status last verified
Nov 2025
First submitted
25 May 2021
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ji L, Jiang H, Cheng Z, Li X, Pang S, Zhang Y, Qiu W, Ma Q, Liu Z, Wang Y, Deng H, Du H, Han-Zhang H, Qian L. Mazdutide 9 mg in Chinese adults with a body mass index >/=30 kg/m2 but without diabetes: A phase 2 randomized controlled trial. Med. 2026 May 8;7(5):101063. doi: 10.1016/j.medj.2026.101063. Epub 2026 Mar 23.

    PubMed 41875890

  • Ji L, Jiang H, Cheng Z, Qiu W, Liao L, Zhang Y, Li X, Pang S, Zhang L, Chen L, Yang T, Li Y, Qu S, Wen J, Gu J, Deng H, Wang Y, Li L, Han-Zhang H, Ma Q, Qian L. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nat Commun. 2023 Dec 14;14(1):8289. doi: 10.1038/s41467-023-44067-4.

    PubMed 38092790

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI362 in people with Overweight/ 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 2 inclusion and 7 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 17 Nov 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percent Change from Baseline in Body Weight (time frame: Baseline ,week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04904913, which also lists 2 linked publications.

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 17 Nov 2025.

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