HealthyPhase 1NCT04270370

A Study of LY3478045 in Healthy Participants

A Phase 1 study testing LY3478045 and Atorvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3478045 and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2020to 23 Jun 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy participants as determined through medical history and physical examination
Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
Have had a stable weight for 3 months prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment
Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator

Who cannot join

Have a history of fructosuria
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis
Have blood pressure greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Dallas
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single-and Multiple Ascending Doses of LY3478045in Healthy Subjects

This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.

Conditions: Healthy
Being tested: LY3478045, Placebo, Atorvastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3478045Drug
Administered orally.
PlaceboDrug
Administered orally.
AtorvastatinDrug
Administered orally.

Study groups in NCT04270370
Study group	Role	What they receive
LY3478045 (Part A)	Experimental	Participants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1. Receives: Drug: LY3478045
Placebo (Part A)	Placebo comparator	Participants received single oral dose of placebo on Day 1. Receives: Drug: Placebo
LY3478045 (Part B)	Experimental	Participants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days. Receives: Drug: LY3478045
Placebo (Part B)	Placebo comparator	Participants received oral dose of placebo QD for 14 days. Receives: Drug: Placebo
LY3478045 + Atorvastatin (Part B)	Experimental	Participants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. Receives: Drug: LY3478045; Drug: Atorvastatin
Placebo + Atorvastatin (Part B)	Placebo comparator	Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. Receives: Drug: Placebo; Drug: Atorvastatin

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, is reported in the Reported Adverse Events module.
Measured: Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)

Secondary outcomes (2)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045
PK: AUC(0-inf) of LY3478045 was reported.
Measured: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose
PK: Maximum Concentration (Cmax) of LY3478045
PK: Cmax of LY3478045 was reported.
Measured: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202023 Jun 2021

First posted17 Feb 2020
Study start16 Mar 2020
Primary completion23 Jun 2021
Study completion23 Jun 2021

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: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04270370
Sponsor's protocol ID: 17537
Other IDs: J2M-MC-GZKA
Status last verified: Feb 2024
First submitted: 13 Feb 2020
Last updated: 25 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single-and Multiple Ascending Doses of LY3478045in Healthy Subjects
ClinicalTrials.gov ID: NCT04270370
Acronym / sponsor ID: 17537
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 16 Mar 2020 (actual)
Primary completion: 23 Jun 2021 (actual)
Study completion: 23 Jun 2021 (actual)
First posted: 17 Feb 2020 (actual)
Results: Posted 25 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
LY3478045 (Part A)	Experimental	Drug: LY3478045Participants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1.
Placebo (Part A)	Placebo comparator	Drug: PlaceboParticipants received single oral dose of placebo on Day 1.
LY3478045 (Part B)	Experimental	Drug: LY3478045Participants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days.
Placebo (Part B)	Placebo comparator	Drug: PlaceboParticipants received oral dose of placebo QD for 14 days.
LY3478045 + Atorvastatin (Part B)	Experimental	Drug: LY3478045, Drug: AtorvastatinParticipants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
Placebo + Atorvastatin (Part B)	Placebo comparator	Drug: Placebo, Drug: AtorvastatinParticipants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Are overtly healthy participants as determined through medical history and physical examination
Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
Have had a stable weight for 3 months prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment
Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator

Key exclusion criteria (4 listed)

Have a history of fructosuria
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis
Have blood pressure greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3478045Administered orally.	Drug	LY3478045 (Part A), LY3478045 (Part B), LY3478045 + Atorvastatin (Part B)
PlaceboAdministered orally.	Drug	Placebo (Part A), Placebo (Part B), Placebo + Atorvastatin (Part B)
AtorvastatinAdministered orally.	Drug	LY3478045 + Atorvastatin (Part B), Placebo + Atorvastatin (Part B)

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.

2 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045
Time frame: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose
PK: Maximum Concentration (Cmax) of LY3478045
Time frame: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose

Results and safety

Results posted to the registry on 25 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Part A)	10	9
20 mg LY3478045 (Part A)	6	6
60 mg LY3478045 (Part A)	6	6
180 mg LY3478045 (Part A)	6	6
500 mg LY3478045 (Part A)	6	6
700 mg LY3478045 (Part A)	6	6
Placebo Once-daily (QD) (Part B)	4	4
Placebo QD + 40 mg Atorvastatin (Part B)	4	4
60 mg LY3478045 QD (Part B)	6	5
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)	6	6
300 mg LY3478045 QD (Part B)	6	6
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)	6	6

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

Time frame: Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B). Number. Unit: participants

Measure	Placebo (Part A) n = 10	20 mg LY3478045 (Part A) n = 6	60 mg LY3478045 (Part A) n = 6	180 mg LY3478045 (Part A) n = 6	500 mg LY3478045 (Part A) n = 6	700 mg LY3478045 (Part A) n = 6	Placebo QD (Part B) n = 4	Placebo QD + 40 mg Atorvastatin (Part B) n = 4	60 mg LY3478045 QD (Part B) n = 6	160 mg LY3478045 QD + 40 mg Atorvastatin (Part B) n = 6	300 mg LY3478045 QD (Part B) n = 6	360 mg LY3478045 QD + 40 mg Atorvastatin (Part B) n = 6
Value	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: All enrolled participants who received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part A)	0 of 10 (0%)	2 of 10 (20%)	0 of 10
20 mg LY3478045 (Part A)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
60 mg LY3478045 (Part A)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
180 mg LY3478045 (Part A)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
500 mg LY3478045 (Part A)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
700 mg LY3478045 (Part A)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Placebo QD (Part B)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Placebo QD + 40 mg Atorvastatin (Part B)	0 of 4 (0%)	2 of 4 (50%)	0 of 4
60 mg LY3478045 QD (Part B)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
300 mg LY3478045 QD (Part B)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)	1 of 6 (16.7%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3478045 and Atorvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04270370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.