A Study of IBI362 in Participants With Obesity or Overweight

Obesity Or Overweight Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05607680
• Other study ID #: CIBI362B301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 19, 2022
• Est. completion date: April 14, 2024

Study information

• Verified date: June 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: April 14, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Obesity Or Overweight
• Overweight

Intervention

Drug:
• Placebo
Placebo administered subcutaneously (SC) once a week.
• IBI362
IBI362 administered subcutaneously (SC) once a week.

Locations

Country	Name	City	State
China	People's Hospital of Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight		Baseline, Week 32
Primary	Percentage of Participants who Achieve =5% Body Weight Reduction		Week 32
Secondary	Percentage of Participants who Achieve =10%Body Weight Reduction		Week 32
Secondary	Percentage of Participants who Achieve =15% Body Weight Reduction		Week 32
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 32
Secondary	Percent Change from Baseline in Body Weight		Baseline, Week 48
Secondary	Percentage of Participants who Achieve =5% Body Weight Reduction		Week 48
Secondary	Percentage of Participants who Achieve =10% Body Weight Reduction		Week 48
Secondary	Percentage of Participants who Achieve =15% Body Weight Reduction		Week 48