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DyslipidemiasPhase 1NCT04052594

A Study of LY3475766 in Healthy Participants

A Phase 1 study testing LY3475766 - IV and LY3475766 - SC in people with Dyslipidemias, run by Eli Lilly and Company at 4 sites 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

This study will evaluate the safety and tolerability of LY3475766 when given to participants with high levels of blood fat called triglycerides. It will also investigate how the body processes the study drug and the effect of the study drug on the body. Information about any side effects will be documented. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dyslipidemias
What is being tested?
LY3475766 - IV and LY3475766 - SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
4 sitesUnited States
Study dates
3 Sep 2019to 31 Mar 2021
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Are overtly healthy males or females, apart from dyslipidemia
  • Male participants must agree to adhere to contraception restrictions
  • Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are postmenopausal
  • Have a body mass index (BMI) >18.5 and <40 kilograms per meter squared (kg/m²)
  • Have clinical laboratory test results within normal reference range, or acceptable deviations per investigator discretion
  • Have a fasting triglyceride (TG) level that is 135 to 499 milligrams per deciliter (mg/dL), inclusive, at both screening and Day -1
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  • Have a fasting low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL, inclusive, at screening and Day -1
  • Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)
  • Have not modified diet or adopted any nutritional lifestyle modification within 3 months prior to randomization

Who cannot join

  • Are taking or have started taking Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin >1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization
  • Are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridine calcium channel blocker, ivabradine, or any other heart rate lowering agent within 1 month or 5 half-lives prior to randomization, whichever is longer
  • Have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetes mellitus) or have 1 of the following at screening: fasting plasma glucose concentration ≥126 mg/dL (7.0 millimoles per liter [mmol/L]) OR a glycated hemoglobin level ≥6.5% (48 millimoles per mole [mmol/mol])
  • Have previously completed or withdrawn from this study or any other study investigating LY3475766, and have previously received the investigational product
  • Have known allergies to LY3475766, related compounds, or any components of the formulation, or history of significant atopy
  • Have a seated heart rate ≤50 beats per minute
  • Have clinically significant abnormal electrocardiogram (ECG) results constituting a risk while taking the investigational product, as determined by the investigator
  • Have an abnormal blood pressure (BP) as determined by the investigator

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • WCCT Global

    Cypress, California, 90630

  • Covance Dallas

    Dallas, Texas, 75247

  • Covance Clinical Research Inc

    Daytona Beach, Florida, 32117

  • Covance Clinical Research Inc

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Single Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3475766

This study will evaluate the safety and tolerability of LY3475766 when given to participants with high levels of blood fat called triglycerides. It will also investigate how the body processes the study drug and the effect of the study drug on the body. Information about any side effects will be documented. This study will last up to 16 weeks for each participant.

Conditions
Dyslipidemias
Being tested
LY3475766 - IV, LY3475766 - SC, Placebo - IV, Placebo - SC
Medical subject headings
Dyslipidemias

What participants receive

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

  • LY3475766 - IVDrug

    Administered IV

  • LY3475766 - SCDrug

    Administered SC

  • Placebo - IVDrug

    Administered IV

  • Placebo - SCDrug

    Administered SC

Study groups in NCT04052594
Study groupRoleWhat they receive
LY3475766 - IVExperimentalLY3475766 administered intravenously (IV) to participants with dyslipidemia
Receives: Drug: LY3475766 - IV
Placebo - IVPlacebo comparatorPlacebo administered IV to participants with dyslipidemia
Receives: Drug: Placebo - IV
LY3475766 - SCExperimentalLY3475766 administered subcutaneously (SC) to participants with dyslipidemia
Receives: Drug: LY3475766 - SC
Placebo - SCPlacebo comparatorPlacebo administered SC to participants with dyslipidemia
Receives: Drug: Placebo - SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 up to Day 85

Secondary outcomes (6)

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766

    PK: AUC of LY3475766

    Measured: Predose up to Day 85

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3475766

    PK: Cmax of LY3475766

    Measured: Predose up to Day 85

  3. PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766

    PK: Tmax of LY3475766

    Measured: Predose up to Day 85

  4. Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)

    PD: Percent Change from Baseline in TG

    Measured: Baseline, Day 85

  5. PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    PD: Percent Change from Baseline in LDL-C

    Measured: Baseline, Day 85

  6. PD: Percent Change from Baseline in Apolipoprotein B (ApoB)

    PD: Percent Change from Baseline in ApoB

    Measured: Baseline, Day 85

Timeline

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

  1. First posted12 Aug 2019
  2. Study start3 Sep 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04052594
Sponsor's protocol ID
17394
Other IDs
J1T-MC-GZEA
Status last verified
15 Apr 2021
First submitted
8 Aug 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaudet D, Gonciarz M, Shen X, Leohr JK, Beyer TP, Day JW, Mullins GR, Zhen EY, Hartley M, Larouche M, Konrad RJ, Benichou O, Ruotolo G. Targeting the angiopoietin-like protein 3/8 complex with a monoclonal antibody in patients with mixed hyperlipidemia: a phase 1 trial. Nat Med. 2025 Aug;31(8):2632-2639. doi: 10.1038/s41591-025-03830-4. Epub 2025 Jul 10.

    PubMed 40640392

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3475766 - IV and LY3475766 - SC in people with Dyslipidemias, run by Eli Lilly and Company at 4 sites 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 9 inclusion and 8 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Day 85). 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 NCT04052594, which also lists 1 linked publication.

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 28 Apr 2021.

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