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Ecnoglutide

Phase 3

T2DM | Small molecule | Metabolic |Co-Diagnostics, Inc.|Last Updated: Sep 10, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment211
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05680155A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM PatientsPHASE3 COMPLETED 211Dec 29, 2022Oct 12, 2024Sep 10, 20251 China
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Study Endpoints
Primary Endpoints
Change from baseline in HbA1c
Baseline, Week 24
Secondary Endpoints
Change from baseline in HbA1c
Baseline, Week 5, Week 9, Week 13, Week 17, Week 29, Week 33, Week 37, Week 45, Week 52
Proportion of subjects with HbA1c < 7% and HbA1c ≤6.5% after treatment
week 24, week 52
Proportion of subjects with HbA1c < 7%, with no severe hypoglycemia or no weight gain
week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
C1-XW003EXPERIMENTALHigh dosage of XW003 once weekly
C1-PlaceboPLACEBO_COMPARATORMatched Placebo once weekly
C2-XW003EXPERIMENTALLow dosage of XW003 once weekly
C2-PlaceboPLACEBO_COMPARATORMatched Placebo once weekly
Interventions
NameTypeDescription
EcnoglutideDRUGSubcutaneous Injection
PlaceboDRUGSubcutaneous Injection with matched volume
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures. 2. Sex: male or female; Age: 18 to 75 years, inclusive 3. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive 4. Have been...

Countries:China
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