A Study of IBI362 in Participants With Obesity or Overweight

NCT ID: NCT05607680

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2024-04-16

Brief Summary

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This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Detailed Description

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Conditions

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Obesity Or Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo,SC,once a week for 48 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered subcutaneously (SC) once a week.

IBI362 4 mg

2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

IBI362 6 mg

2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks

Group Type EXPERIMENTAL

IBI362

Intervention Type DRUG

IBI362 administered subcutaneously (SC) once a week.

Interventions

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Placebo

Placebo administered subcutaneously (SC) once a week.

Intervention Type DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.

Exclusion Criteria

* HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
* 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 thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B;
* History of moderate to severe depression or severe mental illness;
* Any lifetime history of a suicide attempt
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuancheng People's Hospital

Xuancheng, Anhui, China

Site Status

People's Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status

Luoyang Third People's Hospital

Luoyang, He'nan, China

Site Status

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, He'nan, China

Site Status

The First Affiliated Hospital of Nanyang Medical University

Nanyang, He'nan, China

Site Status

The Third Affiliated Hospital of Xinxiang Medical University

Xinxiang, He'nan, China

Site Status

Hebei Petro China Central Hospital

Langfang, Hebei, China

Site Status

The First People's Hospital Of Kunshan

Kunshan, Jiangsu, China

Site Status

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

Affiliated Hospital Of Nantong University

Nantong, Jiangsu, China

Site Status

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Site Status

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Site Status

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Site Status

Shenyang Fifth People's Hospital

Shenyang, Liaoning, China

Site Status

Jinan Central Hospital

Ji'nan, Shandong, China

Site Status

Shandong Provincial Third Hospital

Ji'nan, Shandong, China

Site Status

Qilu Hospital Of Shandong University (Qingdao)

Qingdao, Shandong, China

Site Status

Tai'an Central Hospital

Tai’an, Shandong, China

Site Status

Zibo Municipal Hospital

Zibo, Shandong, China

Site Status

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Site Status

Yan'an University Xianyang Hospital

Xianyang, Shanxi, China

Site Status

Huzhou Central Hospital

Huzhou, Zhejiang, China

Site Status

Lishui Central Hospital

Lishui, Zhejiang, China

Site Status

Countries

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China

References

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Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25.

Reference Type DERIVED
PMID: 40421736 (View on PubMed)

Other Identifiers

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CIBI362B301

Identifier Type: -

Identifier Source: org_study_id

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