A Study of IBI362 in Participants With Obesity or Overweight for Weight Loss

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of IBI362 in participants with overweight and obesity. The main purpose is to learn more about how IBI362 affects body weight. The study period including 4-8 weeks dose titration and 40-44 weeks maintain treatment and 12 weeks follow up.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. 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: hypertension, dyslipidemia, obstructive sleep apnea

2. History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

1. Diabetes mellitus

2. Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening

3. Have used or are currently using weight loss drugs within 3 months before screening

4. History of pancreatitis

5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

6. History of moderate to severe depression，or have a history of serious mental illness

7. Any lifetime history of a suicide attempt