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

NCT04904913 | Completed Phase 2

• 1 other identifier: CIBI362B201
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight/ Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Weight

  Percent Change from Baseline in Body Weight

  Baseline ,week 24

Secondary Outcomes (15)

• 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 Waist Circumference

  Baseline, Week 24

• Change from Baseline in BMI

  Baseline, Week 24

Study Arms (5)

IBI362 high dose

EXPERIMENTAL

high dose IBI362 administered subcutaneously (SC) once a week.

Drug: IBI362

IBI362 low dose

EXPERIMENTAL

Low dose IBI362 administered subcutaneously (SC) once a week.

Drug: IBI362

placebo

PLACEBO COMPARATOR

placebo administered subcutaneously (SC) once a week.

Other: placebo

IBI362 moderate dose

EXPERIMENTAL

moderate dose IBI362 administered subcutaneously (SC) once a week.

Drug: IBI362

IBI362 extra high dose

EXPERIMENTAL

extra high dose IBI362 administered subcutaneously (SC) once a week.

Drug: IBI362

Interventions

IBI362 DRUG

IBI362 administered subcutaneously (SC) once a week.

IBI362 extra high dose; IBI362 high dose; IBI362 low dose; IBI362 moderate dose

placebo OTHER

placebo administered subcutaneously (SC) once a week.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• The weight change of the subjects before and after the introduction period was less than 5.0%

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Peking University people's hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• 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.

  PMID: 38092790 DERIVED

MeSH Terms

Interventions

mazdutide

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 27, 2021
• Study Start: June 8, 2021
• Primary Completion: March 29, 2023
• Study Completion: December 6, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)