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CompletedNCT04904913Updated Nov 17, 2025

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

A Phase 2 interventional study of IBI362 and placebo in Overweight/ Obesity, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
328
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Overweight/ Obesity
03

In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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)
  2. The weight change of the subjects before and after the introduction period was less than 5.0%

Exclusion criteria

Exclusion Criteria:

  1. Diabetes mellitus
  2. Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening
  3. Have used or are currently using weight loss drugs within 3 months before screening
  4. History of pancreatitis
  5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  6. History of moderate to severe depression，or have a history of serious mental illness
  7. Any lifetime history of a suicide attempt
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
328 participants (actual)

Study arms

  • Experimental
    IBI362 high dose

    high dose IBI362 administered subcutaneously (SC) once a week.

    Drug: IBI362

  • Experimental
    IBI362 low dose

    Low dose IBI362 administered subcutaneously (SC) once a week.

    Drug: IBI362

  • Placebo comparator
    placebo

    placebo administered subcutaneously (SC) once a week.

    Other: placebo

  • Experimental
    IBI362 moderate dose

    moderate dose IBI362 administered subcutaneously (SC) once a week.

    Drug: IBI362

  • Experimental
    IBI362 extra high dose

    extra high dose IBI362 administered subcutaneously (SC) once a week.

    Drug: IBI362

Interventions

  • DrugIBI362

    IBI362 administered subcutaneously (SC) once a week.

  • Otherplacebo

    placebo administered subcutaneously (SC) once a week.

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Percent Change from Baseline in Body Weight

    Time frame: Baseline ,week 24

Secondary outcomes

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 24

  3. Absolute change from Baseline in body weight

    Time frame: Baseline, Week 24

  4. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 24

  5. Change from Baseline in BMI

    Time frame: Baseline, Week 24

  6. Change from Baseline in HbA1c

    Time frame: Baseline, Week 24

  7. Change from Baseline in fasting plasma glucose

    Time frame: Baseline, Week 24

  8. Change from Baseline in systolic blood pressure

    Time frame: Baseline, Week 24

  9. Change from Baseline in diastolic blood pressure

    Time frame: Baseline, Week 24

  10. Change from Baseline in total cholesterol

    Time frame: Baseline, Week 24

  11. Change from Baseline in low-density lipoprotein cholesterol

    Time frame: Baseline, Week 24

  12. Change from Baseline in high-density lipoprotein cholesterol

    Time frame: Baseline, Week 24

  13. Change from Baseline in triglyceride

    Time frame: Baseline, Week 24

  14. Change from Baseline in serum uric acid

    Time frame: Baseline, Week 12, Week 24

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

    Time frame: Baseline, Week 24

07

Study locations

1 site
  • Peking University people's hospital
    Beijing, Beijing Municipality 100044, China
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904913
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
May 27, 2021
Start date
Jun 8, 2021
Primary completion
Mar 29, 2023
Completion
Dec 6, 2023
Last update
Nov 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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