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NCT05607680CompletedPhase 3

A Study of IBI362 in Participants With Obesity or Overweight

A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)

Source: ClinicalTrials.gov · Last updated 12 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
610 (actual)
First submitted
23 Oct 2022
Start date
14 Nov 2022
Primary completion date
21 Aug 2023
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Diseases
Obesity
NCT number
NCT05607680

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 610
  • From 14 Nov 2022 to the primary completion date, 21 Aug 2023
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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

Lab values

  • HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
People's Hospital of Peking University
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BeijingChinaUnknown status
China-Japan Union Hospital of JiLin University
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ChangchunChinaUnknown status
Huzhou Central Hospital
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HuzhouChinaUnknown status
Jinan Central Hospital
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Ji'nanChinaUnknown status
Shandong Provincial Third Hospital
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Ji'nanChinaUnknown status
The First People'S Hospital of Kunshan
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KunshanChinaUnknown status
Hebei Petro China Central Hospital
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LangfangChinaUnknown status
Lishui Central Hospital
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LishuiChinaUnknown status
Luoyang Third People's Hospital
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LuoyangChinaUnknown status
The First Affiliated Hospital of Henan University of Science and Technology
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LuoyangChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Affiliated Hospital of Nantong University
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NantongChinaUnknown status
The First Affiliated Hospital of Nanyang Medical University
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NanyangChinaUnknown status
Pingxiang People's Hospital
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PingxiangChinaUnknown status
Qilu Hospital of Shandong University (Qingdao)
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QingdaoChinaUnknown status
Shenyang Fifth People's Hospital
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ShenyangChinaUnknown status
Suzhou Municipal Hospital
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SuzhouChinaUnknown status
Tai'an Central Hospital
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Tai’anChinaUnknown status
Shanxi Bethune Hospital
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TaiyuanChinaUnknown status
Yan'an University Xianyang Hospital
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XianyangChinaUnknown status
The Third Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
Xuancheng People´s Hospital
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XuanchengChinaUnknown status
Zibo Municipal Hospital
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ZiboChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.