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LY2944876

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Opko Health Inc.|Last Updated: May 27, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

LY2944876 · 1 trial · 1 indication

Phase 2 1
NCT02119819A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED420 Analytics
PHASE2COMPLETED
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Baseline, Week 12

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Secondary Endpoints

Change From Baseline in HbA1c at Week 24
Baseline, Week 24
Percent Change From Baseline in Body Weight
Baseline, Week 12; Baseline, Week 24
Change From Baseline in Fasting Blood Glucose
Baseline, Week 12; Baseline, Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
10 mg LY2944876EXPERIMENTAL10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
15 mg LY2944876EXPERIMENTAL15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
30 mg LY2944876EXPERIMENTAL30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
50 mg LY2944876EXPERIMENTAL50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Exenatide extended-releaseEXPERIMENTAL2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
PlaceboPLACEBO_COMPARATORPlacebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Interventions

NameTypeDescription
LY2944876DRUGAdministered SC
Exenatide extended-releaseDRUGAdministered SC
PlaceboDRUGAdministered SC
MetforminDRUGOral
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Men or women with diabetes mellitus Type 2 * Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening * Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screenin...

Countries:United StatesGreeceMexicoPolandPuerto RicoRomania
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Frequently asked questions about LY2944876

What is LY2944876 used for?

LY2944876 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing LY2944876?

LY2944876 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The drug is in Phase 2 clinical trials for Type 2 Diabetes Mellitus.

What phase is LY2944876 in?

LY2944876 is in Phase 2 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not yet received regulatory approval.

What clinical trials is LY2944876 in?

LY2944876 has one completed Phase 2 clinical trial, identified as NCT02119819. This randomized, double-blind, placebo-controlled study enrolled 420 participants with Type 2 Diabetes Mellitus across the United States, Greece, Mexico, Poland, Puerto Rico, and Romania.

Is LY2944876 the same as any other drug?

LY2944876 is the primary identifier for this investigational compound. No alternative names have been reported for this drug in its clinical development program.