NCT06184568

A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

A Multicenter, Randomized, Open-label Phase 3 Study Comparing the Efficacy and Safety of IBI362 Versus Semaglutide in Chinese Participants With Early Type 2 Diabetes and Obesity (DREAMS-3)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups for 32 weeks (active-controlled treatment period). In the extension period, participants originally on mazdutide were assigned to continue for an additional 24 weeks with mazdutide 9 mg or 6 mg based on whether they achieved the weight-loss target. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 32-week active-controlled treatment period, a 24 week extension period and a 4-week drug withdrawal safety follow-up period.

Conditions

• Type 2 Diabetes
• Obesity

Interventions

Type	Name	Description
DRUG	IBI362	Once-weekly injections of gradually increased doses of IBI362, subcutaneously (SC)，starting dose is IBI362 2.0 mg, continuous After 4 weeks of administration, increase to IBI362 4.0 mg. After 4 weeks of continuous administration, continue to increase to IBI362.
DRUG	Semaglutide	Once-weekly injections of gradually increased doses of Semaglutide, subcutaneously (SC)，starting dose is semaglutide 0.25mg, after 4 weeks of continuous administration, increase to semaglutide 0.5mg, after 4 weeks of continuous administration, continue Upgrade to semaglutide 1.0 mg for 24 weeks.

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-09-17
• Completion: 2026-06-30
• First posted: 2023-12-28
• Last updated: 2026-02-18

Locations

1 site across 1 country: China