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Active, Not Recruiting

NCT Number: NCT06164873

A Study of IBI362 9 mg in Chinese Adults With Obesity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

IBI362

Drug

Once-weekly injections of gradually increased doses of IBI362

Placebo

Drug

Once-weekly injections of volume-matched placebo

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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