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LY3493269

Phase 1

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

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

Clinical trial landscape

LY3493269 · 4 trials · 2 indications

Phase 1 4
NCT04682106A Study of LY3493269 in Healthy ParticipantsHealthy
COMPLETED40 Analytics
NCT04498390A Safety Study of LY3493269 in Healthy ParticipantsHealthy
COMPLETED40 Analytics
NCT04515576A Study of LY3493269 in Participants With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED56 Analytics
NCT04178733A Safety Study of LY3493269 Given as a Single Injection in Healthy ParticipantsHealthy
COMPLETED33 Analytics
PHASE1COMPLETED
A Study of LY3493269 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Safety Study of LY3493269 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3493269 in Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)
Baseline through Day 44

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. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Day 43

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

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 24 Hours (AUC [0-24]) of LY3493269
Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
PK: Maximum Concentration (Cmax) of LY3493269
Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses
Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 2. 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants received placebo orally once daily (QD) for three consecutive days.
8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC)EXPERIMENTALParticipants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
24 mg LY3493269 + 600 mg SNACEXPERIMENTALParticipants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.
12 mg LY3493269 + 300 mg SNACEXPERIMENTALParticipants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
4 mg LY3493269 + 300 mg SNACEXPERIMENTALParticipants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.
LY3493269EXPERIMENTAL8, 24 or 48 milligrams (mg) LY3493269 + 250 or 500 mg permeation enhancer sodium caprate(C10) Once daily (QD) administered orally over 3 consecutive study days.
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.
Placebo - SCPLACEBO_COMPARATORParticipants received Placebo subcutaneously (SC).
0.5 mg LY3493269 IVEXPERIMENTALParticipants received 0.5 mg LY3493269 intravenously (IV).
0.15 mg LY3493269 SCEXPERIMENTALParticipants received 0.15 mg LY3493269 SC.
0.5 mg LY3493269 SCEXPERIMENTALParticipants received 0.5 mg LY3493269 SC.
1.5 mg LY3493269 SCEXPERIMENTALParticipants received 1.5 mg LY3493269 SC.

Interventions

NameTypeDescription
LY3493269DRUGAdministered orally.
PlaceboDRUGAdministered orally.
Salcaprozate SodiumDRUGAdministered orally.
DulaglutideDRUGAdministered SC
LY3493269 - SCDRUGAdministered SC
Placebo - SCDRUGAdministered SC
LY3493269 - IVDRUGAdministered IV
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Are male or female not of childbearing potential 2. Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive) 3. Participants who are healthy as determined through medical evaluation including screening medical history, physical examinati...

Countries:SingaporeUnited States
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Frequently asked questions about LY3493269

What is LY3493269 used for?

LY3493269 is an investigational small molecule being studied for Type 2 Diabetes Mellitus and in healthy participants. It is in Phase 1 clinical development by Eli Lilly and Company. The drug is not approved and remains under investigation for metabolic conditions.

Who makes LY3493269?

LY3493269 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the stock exchange under the ticker LLY. The company is conducting Phase 1 clinical trials to evaluate the safety and effects of this investigational small molecule.

What phase is LY3493269 in?

LY3493269 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All completed trials for LY3493269 are Phase 1 studies, and the drug is not yet available for clinical use.

What clinical trials is LY3493269 in?

LY3493269 has been studied in four completed Phase 1 clinical trials. These include NCT04178733 and NCT04498390 in healthy participants in Singapore, NCT04515576 in participants with Type 2 Diabetes in the United States, and NCT04682106 in healthy participants in Singapore.

Is LY3493269 the same as any other drug?

LY3493269 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being developed by Eli Lilly and Company for metabolic conditions, and it is not known to be identical to any other marketed medication.