A Study of IBI362 in Participants With Obesity or Overweight

• Status: Not yet recruiting
• Trial end date: 2024-04-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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