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DWP16001

Phase 3

T2DM (Type 2 Diabetes Mellitus) | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Jun 2, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment510
FDA Designations
No designations recorded
Clinical trial landscape

DWP16001 · 1 trial · 1 indication

Phase 3 1
NCT07619833To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes MellitusT2DM (Type 2 Diabetes Mellitus)
NOT YET_RECRUITING510 Analytics
PHASE3NOT YET_RECRUITING
To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus
T2DM (Type 2 Diabetes Mellitus)
NCT07619833510
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Study Endpoints
Primary Endpoints
Change in HbA1c at Week 24 from Baseline after Randomization
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Combination GroupEXPERIMENTAL -
DWP16001 monotherapy GroupEXPERIMENTAL -
DWC202518 monotherapy GroupEXPERIMENTAL -
Interventions
NameTypeDescription
DWP16001DRUGDWP16001 0.3mg, Tablets, Orally, Once daily
DWC202518DRUGDWC202518, Tablets, Orally, Once daily
Placebo of DWP16001DRUGDWP16001 placebo-matching tablets
Placebo of DWC202518DRUGDWC202518 placebo-matching tablets
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed. 2. Male or female adult aged ≥18 and ≤80 years. Note: The...

Countries:South Korea
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