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Trial · Interventional

Status unknownPhase 3Registry data

A Study of IBI362 9 mg in Chinese Adults With Obesity

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
462 participants (actual)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
27 Dec 2023
Primary completion
27 Jun 2025 (estimated)
Completion
19 Sept 2025 (estimated)
First posted
11 Dec 2023
Last update posted
27 Aug 2024
Conditions
Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    A Study of IBI362 9 mg in Chinese Adults With Obesity

    NCT06164873

    27 Dec 2023 to est. 19 Sept 2025

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 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Interventions

  • IBI362Drug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

  • Experimental

    IBI362

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change from Baseline in Body Weight

    Time frame · Week 60

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

    Time frame · Week 60

Secondary outcomes(8)
  1. Proportion of Participants who Achieve ≥10% Body Weight Reduction

    Time frame · Week 60

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

    Time frame · Week 60

  3. Proportion of Participants who Achieve ≥20% Body Weight Reduction

    Time frame · Week 60

  4. Change from Baseline in Waist Circumference

    Time frame · Week 60

  5. Change from Baseline in Systolic Blood Pressure

    Time frame · Week 60

  6. Percent Change from Baseline in Triglycerides

    Time frame · Week 60

  7. Percent Change from Baseline in non-high-density lipoprotein cholesteroal

    Time frame · Week 60

  8. Percent Change from Baseline in low-density lipoprotein cholesterol

    Time frame · Week 60

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.

A trial that is still running, or that stopped early, may post results later.

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 · 2026

6 results

Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial.

Gao et al. 2026JAMA

PMID 42251595DOI 10.1001/jama.2026.8142PUB-42251595

Full text at the publisher6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, age 18 years or older at the time of signing informed consent * Have a BMI ≥30 kg/m2 * Have a history of at least one self-reported unsuccessful dietary effort to lose body weight For subjects with T2D at screening: * Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening * Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening * HbA1c 7.0-10.0% (both inclusive) at screening * Fasting blood glucose ≤11.1 mmol/L at screening Exclusion Criteria: • A self-reported change in body weight above 5% within 3 months before screening For subjects without T2D at screening: • HbA1c ≥6.5% as measured by local laboratory at screening For subjects with T2D at screening: * Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment * Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;

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