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CompletedNCT05960851Updated Jan 10, 2024

A Study of LY3871801 in Healthy Asian and Non-Asian Participants

A Phase 1 interventional study of LY3871801 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-10.

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

From the registry’s dates

  • Primary completion was Oct 2023, 2 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it in these participants. The study will be conducted in two parts (A \& B). The study will last up to approximately 24 days excluding the screening period.

02

Conditions studied

  • Healthy
03

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Are Japanese, Chinese, or Non-Asian participants who are overtly healthy as determined by medical evaluation
  • Have body weight of >/= 45 kilograms (kg) \& a body mass index (BMI) in the range of 18.5 to 29.5 kilogram per square meter (kg/m²). The Japanese participants must have a body weight of 45 to 85 kg and a BMI of 18.0 to 29.5 kg/m²

Exclusion criteria

Exclusion Criteria:

  • Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy
  • Have a significant history of or current cardiovascular or heart failure (based on New York Heart Association Functional Classification), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Are females who are lactating or have a positive pregnancy test at screening or Day 1
  • Positive for drug or alcohol screen at screening or Day -1
  • Smoke more than 10 cigarettes per day
05

Study design

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

Study arms

  • Experimental
    LY3871801 (Part A)

    LY3871801 administered orally in Japanese and Non-Asian Participants.

    Drug: LY3871801

  • Placebo comparator
    Placebo (Part A)

    Placebo administered orally in Japanese and Non-Asian Participants.

    Drug: Placebo

  • Experimental
    LY3871801 (Part B)

    LY3871801 administered orally in Chinese Participants.

    Drug: LY3871801

  • Placebo comparator
    Placebo (Part B)

    Placebo administered orally in Chinese Participants.

    Drug: Placebo

Interventions

  • DrugLY3871801

    Administered orally.

  • DrugPlacebo

    Administered orally.

06

What researchers measure

Primary outcomes

  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

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

    Time frame: Predose up to 24 days post dose

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3871801

    PK: Cmax of LY3871801

    Time frame: Predose on Day 1 up to postdose on Day 17

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3871801

    PK: AUC of LY3871801

    Time frame: Predose on Day 1 up to postdose on Day 17

07

Study locations

1 site
  • Altasciences Clinical Los Angeles, Inc
    Cypress, California 90630, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05960851
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Aug 9, 2023
Primary completion
Oct 25, 2023
Completion
Oct 25, 2023
Last update
Jan 10, 2024

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
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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

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