A Study of IBI362 9 mg in Chinese Adults With Obesity

NCT06164873 | Active Not Recruiting Phase 3

• 1 other identifier: CIBI362B302
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Percent Change from Baseline in Body Weight

  Week 60

• Proportion of Participants who Achieve ≥5% Body Weight Reduction

  Week 60

Secondary Outcomes (8)

• Proportion of Participants who Achieve ≥10% Body Weight Reduction

  Week 60

• Proportion of Participants who Achieve ≥15% Body Weight Reduction

  Week 60

• Proportion of Participants who Achieve ≥20% Body Weight Reduction

  Week 60

• Change from Baseline in Waist Circumference

  Week 60

• Change from Baseline in Systolic Blood Pressure

  Week 60

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

IBI362

EXPERIMENTAL

Drug: IBI362

Interventions

IBI362 DRUG

Once-weekly injections of gradually increased doses of IBI362

IBI362

Placebo DRUG

Once-weekly injections of volume-matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Obesity

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 27, 2023
• Primary Completion: June 27, 2025
• Study Completion: September 19, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)