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LY3493269

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Trials Updated: Jan 14, 2025

LY3493269 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Aug 2020

LY3493269 target and mechanism

ModalitySmall molecule

Also known as LY3493269 - SC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

LY3493269 clinical trials

LY3493269 · 1 trial · 1 indication

Phase 1 1
NCT04515576A Study of LY3493269 in Participants With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED56 Analytics
PHASE1COMPLETED
A Study of LY3493269 in Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through final follow-up at Day 57

TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269
Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
PK: Maximum Observed Drug Concentration (Cmax) of LY3493269
Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.
Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose
Baseline, Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1.5 milligrams (mg) DulaglutideACTIVE_COMPARATORParticipants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.
0.3 mg LY3493269EXPERIMENTALParticipants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
1 mg LY3493269EXPERIMENTALParticipants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
0.75/1.5/3 mg LY3493269EXPERIMENTALParticipants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
1.5/3/4/5 mg LY3493269EXPERIMENTALParticipants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
PlaceboPLACEBO_COMPARATORParticipants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.

Interventions

NameTypeDescription
LY3493269DRUGAdministered SC
DulaglutideDRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Are male or female not of childbearing potential * Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening * Have had a stable body weight (\<5% body weight change) for the 3 months prior to screening * Have not modified their diet or ado...

Countries:United States
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Frequently asked questions about LY3493269

What is LY3493269 used for?

LY3493269 is an investigational small molecule being studied for the treatment of type 2 diabetes mellitus. It is in Phase 1 clinical development and is not approved for any indication. Eli Lilly and Company is evaluating it in adults with type 2 diabetes.

Who is developing LY3493269?

LY3493269 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sponsor of the clinical program evaluating this small molecule in type 2 diabetes.

What phase is LY3493269 in?

LY3493269 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has completed one trial in participants with type 2 diabetes.

What clinical trials is LY3493269 in?

LY3493269 has been studied in one Phase 1 trial, NCT04515576, titled A Study of LY3493269 in Participants With Type 2 Diabetes. The trial was completed, enrolled 56 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.

Is LY3493269 the same as LY3493269 - SC?

Yes, LY3493269 - SC is an alternative name for LY3493269. Both names refer to the same investigational small molecule developed by Eli Lilly and Company for type 2 diabetes, so searches using either name point to the same asset.