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Empagliflozin

Phase 3

Metabolic Syndrome | Small molecule | Metabolic |Collegium Pharmaceutical, Inc.|Last Updated: Aug 27, 2024

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05905965Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatmentPHASE3 RECRUITING 200May 1, 2023Mar 31, 2026Aug 27, 20241 Poland
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Study Endpoints
Primary Endpoints
BMI (Body Mass Index)
0-6 months

change in BMI between study arms

concentration of HbA1c (glycated hemoglobin)
0-6 months

change in glycated hemoglobin plasma concentration between study arms

Secondary Endpoints
concentration of LDL-C (low density cholesterol serum concentration)
0-6 months
concentration of triglycerides
0-6 months
concentration of CRP (c-reactive protein)
0-6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Empagliflozin 20 mgEXPERIMENTALPatients receiving empagliflozin 20 mg daily
Empagliflozin 10 mgACTIVE_COMPARATORPatients receiving empagliflozin 10 mg daily
Interventions
NameTypeDescription
Empagliflozin 20 mgDRUGPatients receiving empagliflozin 20 mg daily - experimental arm
Empagliflozin 10 mgDRUGPatients receiving empagliflozin 10 mg daily - control arm
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or body mass index (BMI) ≥30 kg/m2) and two of the three following criteria: 1. high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and...

Countries:Poland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05905965primaryCompletionDate: changed
LOWMay 24, 2026NCT05905965studyFirstPostDate: changed