CompletedNCT04178733Updated Jan 14, 2025Results posted

A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants

A Phase 1 interventional study of LY3493269 - SC and Placebo - SC in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 33
Allocation: Randomized
Ages: 21 Years to 65 Years
Sex: All

Study summary

This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Conditions studied

Healthy

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Overtly healthy male or a female who cannot get pregnant
Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
Have veins suitable for ease of blood sampling

Exclusion criteria

Exclusion Criteria:

Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
Have previously completed or withdrawn from this study
Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Have been treated with weight loss medications within 3 months of screening

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 33 participants (actual)

Study arms

Placebo comparator
Placebo - SC
Participants received Placebo subcutaneously (SC).
Drug: Placebo - SC
Experimental
0.5 mg LY3493269 IV
Participants received 0.5 mg LY3493269 intravenously (IV).
Drug: LY3493269 - IV
Experimental
0.15 mg LY3493269 SC
Participants received 0.15 mg LY3493269 SC.
Drug: LY3493269 - SC
Experimental
0.5 mg LY3493269 SC
Participants received 0.5 mg LY3493269 SC.
Drug: LY3493269 - SC
Experimental
1.5 mg LY3493269 SC
Participants received 1.5 mg LY3493269 SC.
Drug: LY3493269 - SC

Interventions

DrugLY3493269 - SC
Administered SC
DrugPlacebo - SC
Administered SC
DrugLY3493269 - IV
Administered IV

What researchers measure

Primary outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through final follow-up (Up To Day 43)

Secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269
Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269
Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination
PK: Maximum Concentration (Cmax) of LY3493269
PK: Maximum Concentration (Cmax) of LY3493269
Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
PK: Time to Maximum Concentration (Tmax) of LY3493269
PK: Time to Maximum Concentration (Tmax) of LY3493269
Time frame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination

Results

Posted Jan 14, 2025

Participant flow

Participant flow — Overall Study
Milestone	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC
Started	6	6	6	7	8
Received at least one dose of study drug	6	6	6	6	6
Completed	6	6	6	6	6
Not completed	0	0	0	1	2
Withdrew: Investigator decision	0	0	0	1	2

Outcome measures

PrimaryNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time frame:: Baseline through final follow-up (Up To Day 43)
Reported as:: Count of participants · Participants

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Participants	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0	0	0	0	0

SecondaryPharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269

Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269

Time frame:: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination
Reported as:: Geometric mean · nanograms*hour per milliliter (ng*h/mL)

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269
nanogramshour per milliliter (ngh/mL)	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269	4990 ± 26	21800 ± 24	24600 ± 23	7300 ± 21

SecondaryPK: Maximum Concentration (Cmax) of LY3493269

PK: Maximum Concentration (Cmax) of LY3493269

Time frame:: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
Reported as:: Geometric mean · nanograms per milliliter (ng/mL)

PK: Maximum Concentration (Cmax) of LY3493269
nanograms per milliliter (ng/mL)	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC
PK: Maximum Concentration (Cmax) of LY3493269	16.4 ± 19	68.8 ± 40	181 ± 15	247 ± 27

SecondaryPK: Time to Maximum Concentration (Tmax) of LY3493269

PK: Time to Maximum Concentration (Tmax) of LY3493269

Time frame:: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
Reported as:: Median · hours (hr)

PK: Time to Maximum Concentration (Tmax) of LY3493269
hours (hr)	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC
PK: Time to Maximum Concentration (Tmax) of LY3493269	12.01 (6.00 to 96.73)	12.06 (12.00 to 96.00)	0.39 (0.25 to 2.00)	12.00 (12.00 to 96.08)

Adverse events

Collected over Baseline Up To 43 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo SC	0/6 (0%)	0/6 (0%)	3/6 (50%)
0.15 mg LY3493269 SC	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
0.5 mg LY3493269 SC	0/6 (0%)	0/6 (0%)	6/6 (100%)
0.5 mg LY3493269 IV	0/6 (0%)	0/6 (0%)	6/6 (100%)
1.5 mg LY3493269 SC	0/6 (0%)	0/6 (0%)	6/6 (100%)

Most frequent other events

Showing 10 of 49

Most frequent other events
Event	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC
Abdominal distensionGastrointestinal disorders	2/6	1/6	3/6	5/6	3/6
Decreased appetiteMetabolism and nutrition disorders	0/6	1/6	2/6	5/6	5/6
Sinus tachycardiaCardiac disorders	0/6	0/6	0/6	2/6	3/6
NauseaGastrointestinal disorders	0/6	0/6	1/6	3/6	3/6
VomitingGastrointestinal disorders	0/6	0/6	0/6	1/6	3/6
Catheter site erythemaGeneral disorders	0/6	1/6	3/6	2/6	0/6
PyrexiaGeneral disorders	0/6	0/6	0/6	3/6	1/6
HeadacheNervous system disorders	0/6	0/6	1/6	2/6	3/6
Abdominal discomfortGastrointestinal disorders	0/6	0/6	0/6	2/6	0/6
Catheter site bruiseGeneral disorders	0/6	2/6	0/6	2/6	0/6

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC	Total
Mean	47.0 ± 13.9	40.8 ± 8.6	43.5 ± 8.5	36.5 ± 12.7	34.7 ± 9.9	40.5 ± 11.2

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC	Total
Female	0	0	0	0	0	0
Male	6	6	6	6	6	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC	Total
Hispanic or Latino	0	0	0	0	0	0
Not Hispanic or Latino	6	6	6	6	6	30
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	6	6	6	6	6	30
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0
White	0	0	0	0	0	0
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Placebo SC	0.15 mg LY3493269 SC	0.5 mg LY3493269 SC	0.5 mg LY3493269 IV	1.5 mg LY3493269 SC	Total
Singapore	6	6	6	6	6	30

Study locations

1 site

Lilly Centre for Clinical Pharmacology
Singapore, 138623, Singapore

References and documents

Study documents

Study protocol · Oct 10, 2019
Statistical analysis plan · Jan 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04178733
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Nov 26, 2019
Start date: Jan 10, 2020
Primary completion: May 11, 2020
Completion: May 11, 2020
Results posted: Jan 14, 2025
Last update: Jan 14, 2025

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Eli Lilly and Company

Start the discussion