HealthyPhase 1NCT04178733
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
A Phase 1 study testing LY3493269 - SC and LY3493269 - IV in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3493269 - SC and LY3493269 - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Jan 2020to 11 May 2020
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Have previously completed or withdrawn from this study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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants
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
- Healthy
- Being tested
- LY3493269 - SC, Placebo - SC, LY3493269 - IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3493269 - SCDrug
Administered SC
Placebo - SCDrug
Administered SC
LY3493269 - IVDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Placebo - SC | Placebo comparator | Participants received Placebo subcutaneously (SC). Receives: Drug: Placebo - SC |
| 0.5 mg LY3493269 IV | Experimental | Participants received 0.5 mg LY3493269 intravenously (IV). Receives: Drug: LY3493269 - IV |
| 0.15 mg LY3493269 SC | Experimental | Participants received 0.15 mg LY3493269 SC. Receives: Drug: LY3493269 - SC |
| 0.5 mg LY3493269 SC | Experimental | Participants received 0.5 mg LY3493269 SC. Receives: Drug: LY3493269 - SC |
| 1.5 mg LY3493269 SC | Experimental | Participants received 1.5 mg LY3493269 SC. Receives: Drug: LY3493269 - SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through final follow-up (Up To Day 43)
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start10 Jan 2020
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178733
- Sponsor's protocol ID
- 17452
- Other IDs
- J1X-MC-GZHA
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2019
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No