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

NCT06772168 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • CMG Pharmaceutical Co. Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2026-11-04
Completion
2027-02-01

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772168 on ClinicalTrials.gov