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
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| People's Hospital of Peking University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| China-Japan Union Hospital of JiLin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Ji'nan | China | Unknown status |
| Shandong Provincial Third Hospital Coordinator of this site? Confirm its status | Ji'nan | China | Unknown status |
| The First People'S Hospital of Kunshan Coordinator of this site? Confirm its status | Kunshan | China | Unknown status |
| Hebei Petro China Central Hospital Coordinator of this site? Confirm its status | Langfang | China | Unknown status |
| Lishui Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Unknown status |
| Luoyang Third People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| The First Affiliated Hospital of Nanyang Medical University Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Unknown status |
| Qilu Hospital of Shandong University (Qingdao) Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shenyang Fifth People's Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Tai'an Central Hospital Coordinator of this site? Confirm its status | Tai’an | China | Unknown status |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Yan'an University Xianyang Hospital Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| The Third Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xuancheng People´s Hospital Coordinator of this site? Confirm its status | Xuancheng | China | Unknown status |
| Zibo Municipal Hospital Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.