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LY2881835

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Jun 19, 2019

LY2881835 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2011

LY2881835 target and mechanism

Molecular targetFFAR1
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

LY2881835 clinical trials

LY2881835 · 1 trial · 1 indication

Phase 1 1
NCT01358981A Study of LY2881835 in Healthy People and People With DiabetesDiabetes Mellitus, Type 2
COMPLETED18 Analytics
PHASE1COMPLETED
A Study of LY2881835 in Healthy People and People With Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Clinically Significant Adverse Effects
Baseline to study completion up to 3 months

Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835
Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835
Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835
Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY2881835EXPERIMENTALOne cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A). There is a washout period of at least 5 days between periods (doses).
placeboPLACEBO_COMPARATOROne cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B. There is a washout period of at least 5 days between periods (doses).

Interventions

NameTypeDescription
LY2881835DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All subjects: * Are a healthy male or a healthy female who cannot become pregnant, or are patients with Type 2 Diabetes Mellitus (T2DM) who are not taking any drugs to lower blood sugar except metformin * Have a body mass index (BMI) of at least 18.5 kilograms per meter squared...

Countries:Singapore
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Frequently asked questions about LY2881835

What is LY2881835?

LY2881835 is an investigational small molecule developed by Eli Lilly and Company for the treatment of type 2 diabetes mellitus. It is a Phase 1 clinical candidate and has not been approved for any indication. The compound was studied in a single completed early-stage trial.

What does LY2881835 target?

LY2881835 targets FFAR1, also known as free fatty acid receptor 1. It acts as an agonist at this receptor. FFAR1 is a G protein-coupled receptor implicated in glucose-dependent insulin secretion, which is the rationale for evaluating the compound in type 2 diabetes.

Who makes LY2881835?

LY2881835 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound in type 2 diabetes and healthy volunteers.

What phase is LY2881835 in?

LY2881835 is in Phase 1 development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The only recorded trial of the compound is completed, and no active trials are ongoing.

What clinical trials is LY2881835 in?

LY2881835 was evaluated in one completed Phase 1 trial, NCT01358981, titled A Study of LY2881835 in Healthy People and People With Diabetes. The trial enrolled 18 participants in Singapore, was randomized and placebo controlled, and included healthy volunteers alongside people with type 2 diabetes.