Current partner codePEPTIDESDE
NCT06164873·Phase 3·INTERVENTIONAL

A Study of IBI362 9 mg in Chinese Adults With Obesity

Status

Active, not recruiting

Phase

Phase 3

Enrollment

462

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

IBI362

Once-weekly injections of gradually increased doses of IBI362

DRUG

Placebo

Once-weekly injections of volume-matched placebo

Timeline

From registration to results.

  1. First posted

    Dec 11, 2023

  2. Study start

    Dec 27, 2023

  3. Primary completion

    Jun 27, 2025

  4. Study completion

    Sep 19, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Aug 27, 2024

Outcomes

What the study measures.

Primary outcomes

Percent Change from Baseline in Body Weight

Time frame · Week 60

Proportion of Participants who Achieve ≥5% Body Weight Reduction

Time frame · Week 60

Secondary outcomes

Proportion of Participants who Achieve ≥10% Body Weight Reduction

Time frame · Week 60

Proportion of Participants who Achieve ≥15% Body Weight Reduction

Time frame · Week 60

Proportion of Participants who Achieve ≥20% Body Weight Reduction

Time frame · Week 60

Change from Baseline in Waist Circumference

Time frame · Week 60

Change from Baseline in Systolic Blood Pressure

Time frame · Week 60

Percent Change from Baseline in Triglycerides

Time frame · Week 60

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

Time frame · Week 60

Percent Change from Baseline in low-density lipoprotein cholesterol

Time frame · Week 60

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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;

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Peking University People's Hospital

Beijing, Beijing Municipality, China

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Put the record in context.

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