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Trial · Interventional

CompletedPhase 3Registry data

A Study of IBI362 in Participants With Obesity or Overweight

NCTNCT05607680 (opens ClinicalTrials.gov in a new tab)Other idCIBI362B301
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
610 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Triple masking
Countries
1 country

China

Start
14 Nov 2022
Primary completion
21 Aug 2023
Completion
16 Apr 2024
First posted
7 Nov 2022
Last update posted
12 Nov 2024
Conditions
Obesity Or Overweight

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

    A Study of IBI362 in Participants With Obesity or Overweight

    NCT05607680

    14 Nov 2022 to 16 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Interventions

  • PlaceboDrug
  • IBI362Drug

Arms3

  • Placebo comparator

    Placebo

    Placebo,SC,once a week for 48 weeks

  • Experimental

    IBI362 4 mg

    2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks

  • Experimental

    IBI362 6 mg

    2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 32

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

    Time frame · Week 32

Secondary outcomes(20)

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

    Time frame · Week 32,Week 48

  2. Percentage of Participants who Achieve ≥15% Body Weight Reduction

    Time frame · Week 32,Week 48

  3. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 32,Week 48

  4. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 48

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

    Time frame · Week 48

  6. Percentage of Participants who Achieve ≥20% Body Weight Reduction

    Time frame · Week 32, Week 48

  7. Change from Baseline in Neck Circumference

    Time frame · Baseline, Week 32, Week 48

  8. Change from Baseline in Hip Circumference

    Time frame · Baseline, Week 32, Week 48

  9. Change from Baseline in Body Weight

    Time frame · Baseline, Week 32, Week 48

  10. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 60

  11. Change from Baseline in Body Mass Index (BMI)

    Time frame · Baseline, Week 32, Week 48

  12. Percentage of Participants with BMI < 24 kg/m2

    Time frame · Week 32, Week 48

  13. Change from Baseline in Systolic Blood Pressure

    Time frame · Baseline, Week 32, Week 48

  14. Change from Baseline in Diastolic Blood Pressure

    Time frame · Baseline, Week 32, Week 48

  15. Change from Baseline in Triglyceride

    Time frame · Baseline, Week 32,Week 48

  16. Change from Baseline in Total Cholesterol

    Time frame · Baseline, Week 32, Week 48

  17. Change from Baseline in Low-density Lipoprotein Cholesterol

    Time frame · Baseline, Week 32, Week 48

  18. Change from Baseline in High-density Lipoprotein Cholesterol

    Time frame · Baseline, Week 32, Week 48

  19. Change from Baseline in Serum Uric Acid

    Time frame · Baseline, Week 32, Week 48

  20. Change from Baseline in Alanine Aminotransferase

    Time frame · Baseline, Week 32, Week 48

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

12 results

Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.

Ji et al. 2025The New England journal of medicinecited by 88

PMID 40421736DOI 10.1056/nejmoa2411528PUB-40421736

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: • Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea. Exclusion Criteria: * HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes; * 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 thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B； * History of moderate to severe depression or severe mental illness; * Any lifetime history of a suicide attempt

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