NCT06772168

Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia

A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: CMG Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drug CMG190303 to treat Type 2 Diabetes and Dyslipidemia in adults. It will also learn about the safety of CMG190303. The main questions it aims to answer are: -Primary Objectives: 1. To compare the change in HbA1c from baseline to 24 weeks between CMG190303 and Rosuvastatin 2. To compare the change in LDL-C from baseline to 24 weeks between CMG190303 and Dapagliflozin

Conditions

• Dyslipidemia
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	CMG190303(Dapagliflozin/Rosuvastatin)	0-8 week: Dapagliflozin 10mg and Rosuvastatin 5mg 8-16 week: Dapagliflozin 10mg and Rosuvastatin 10mg 16-24 week: Dapagliflozin 10mg and Rosuvastatin 20mg
DRUG	Comparator 1: Dapagliflozin/Rosuvastatin placebo	0-24 week: Dapagliflozin 10mg and Rosuvastatin placebo
DRUG	Rosuvastatin/Dapagliflozin placebo	0-8 week: Dapagliflozin placebo and Rosuvastatin 5mg 8-16 week: Dapagliflozin placebo and Rosuvastatin 10mg 16-24 week: Dapagliflozin placebo and Rosuvastatin 20mg

Timeline

• Start date: 2024-04-19
• Primary completion: 2026-11-04
• Completion: 2027-02-01
• First posted: 2025-01-13
• Last updated: 2026-01-15

Locations

24 sites across 1 country: South Korea