Recent Updates
Recently added Catalysts

Empagliflozin

Phase 3

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

Target and mechanism

Molecular targetSLC5A2
Target classInhibitor
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Empagliflozin · 1 trial · 1 indication

Phase 3 1
NCT05905965Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatmentMetabolic Syndrome
RECRUITING200 Analytics
PHASE3RECRUITING
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Metabolic SyndromeUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about Empagliflozin

What is Empagliflozin used for?

Empagliflozin is being studied for the treatment of Metabolic Syndrome. It is an investigational small molecule in Phase 3 clinical development. The drug is being evaluated in a clinical trial enrolling 200 participants with Metabolic Syndrome.

Who is developing Empagliflozin?

Empagliflozin is being developed by Collegium Pharmaceutical, Inc., a company traded on the stock exchange under the ticker COLL. The company is conducting a Phase 3 clinical trial of the drug for Metabolic Syndrome.

What phase is Empagliflozin in?

Empagliflozin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants with Metabolic Syndrome.

What clinical trials is Empagliflozin in?

Empagliflozin is being studied in a Phase 3 clinical trial with the identifier NCT05905965. The trial is titled 'Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment' and is recruiting 200 participants in Poland.

Is Empagliflozin the same as Empagliflozin 20 mg?

Yes, Empagliflozin is also known as Empagliflozin 20 mg. The clinical trial NCT05905965 evaluates the efficacy of a double dose compared to a standard dose of Empagliflozin for the treatment of Metabolic Syndrome.