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Recruiting NCT05607680

A Study of IBI362 in Participants With Obesity or Overweight

Conditions: Obesity Or Overweight

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 600
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Location: China

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05607680). StuddyBuddy aggregates publicly available trial information.