A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects

This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other.

In the first stage of this study, about 240 subjects will be enrolled. Qualified subjects will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 low dose, IBI362 moderate dose, IBI362 high dose groups, in every group, subjects will be randomized to IBI362 and placebo groups at a ratio of 3:1. Random stratification is performed based on BMI < 28.0 kg/㎡ and BMI≥28.0 kg/㎡. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a-24 week double-blind treatment period, and a 12-week drug discontinuation follow-up period. During the entire research period, the subjects shall maintain diet and exercise control.

The second stage is IBI362 extra high dose study, about 80 subjects will be enrolled. Qualified participants will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 extra high dose and placebo groups at a ratio of 3:1. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a 24-week double-blind treatment period, a 24-week extended treatment period, and a 12-week drug discontinuation follow-up period. The 24-week extended treatment period is optional. During the entire research period, the subjects shall maintain diet and exercise control.

Study Overview

• Status: Completed
• Conditions: Overweight/ Obesity
• Intervention / Treatment: Drug: IBI362; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The first stage: Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² with at least one of the following comorbidities: hyperphagia, pre-diabetes, hypertension, dyslipidemia, fatty liver disease, weight-bearing joint pain, obesity-induced dyspnea or obstructive sleep apnea syndrome; The second stage: Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²)
2. The weight change of the subjects before and after the introduction period was less than 5.0%

Exclusion Criteria:

1. Diabetes mellitus
2. Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening
3. Have used or are currently using weight loss drugs within 3 months before screening
4. History of pancreatitis
5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
6. History of moderate to severe depression，or have a history of serious mental illness
7. Any lifetime history of a suicide attempt

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI362 high dose; high dose IBI362 administered subcutaneously (SC) once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.
Experimental: IBI362 low dose; Low dose IBI362 administered subcutaneously (SC) once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.
Placebo Comparator: placebo; placebo administered subcutaneously (SC) once a week.	Other: placebo; placebo administered subcutaneously (SC) once a week.
Experimental: IBI362 moderate dose; moderate dose IBI362 administered subcutaneously (SC) once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.
Experimental: IBI362 extra high dose; extra high dose IBI362 administered subcutaneously (SC) once a week.	Drug: IBI362; IBI362 administered subcutaneously (SC) once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change from Baseline in Body Weight	Percent Change from Baseline in Body Weight	Baseline ,week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Waist Circumference	Baseline, Week 24
Percentage of Participants who Achieve ≥5% Body Weight Reduction	Baseline, Week 24
Percentage of Participants who Achieve ≥10% Body Weight Reduction	Baseline, Week 24
Absolute change from Baseline in body weight	Baseline, Week 24
Change from Baseline in BMI	Baseline, Week 24
Change from Baseline in HbA1c	Baseline, Week 24
Change from Baseline in fasting plasma glucose	Baseline, Week 24
Change from Baseline in systolic blood pressure	Baseline, Week 24
Change from Baseline in diastolic blood pressure	Baseline, Week 24
Change from Baseline in total cholesterol	Baseline, Week 24
Change from Baseline in low-density lipoprotein cholesterol	Baseline, Week 24
Change from Baseline in high-density lipoprotein cholesterol	Baseline, Week 24
Change from Baseline in triglyceride	Baseline, Week 24
Change from Baseline in serum uric acid	Baseline, Week 12, Week 24
Change from Baseline in IWQoL-Lite-CT questionnaire scores	Baseline, Week 24

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Ji L, Jiang H, Cheng Z, Qiu W, Liao L, Zhang Y, Li X, Pang S, Zhang L, Chen L, Yang T, Li Y, Qu S, Wen J, Gu J, Deng H, Wang Y, Li L, Han-Zhang H, Ma Q, Qian L. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nat Commun. 2023 Dec 14;14(1):8289. doi: 10.1038/s41467-023-44067-4.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; mazdutide
• Other Study ID Numbers: CIBI362B201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No