CClinicalTrials.gg
RecruitingNCT07767487Updated Sep 22, 2026

A Study of LY4226695 in Healthy Participants

A Phase 1 interventional study of LY4226695 and LY4226695 in Healthy, sponsored by Eli Lilly and Company. Recruiting at 2 sites in 2 countries. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

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

Phase
Phase 1
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
22 Years to 65 Years
Sex
All
01

Study summary

The main purpose of this study is to assess how well LY4226695 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant in Parts A \& D, the study will last about 64 days and will include a stay in the Clinical Research Unit (CRU) lasting at most 7 days. For each participant in Parts B \& C, the study will last about 92 days and will include 5 stays in the CRU with each visit lasting at most 7 days.

02

Conditions studied

  • Healthy
03

Who can participate

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

Inclusion criteria

  • Have a screening body mass index (BMI) in the range of 18.5 to 35 kilograms per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening.
  • Individuals assigned male at birth must agree to adhere to contraception restrictions and individuals assigned female at birth must not be of childbearing potential.
  • Part B Chinese participants:

    • To qualify as a Chinese participant for the purpose of this study, all the participants' biological grandparents must be Chinese and born in China.
  • Part C Japanese participants:

    • To qualify as a Japanese participant for the purpose of this study, all the participants' biological grandparents must be Japanese and born in Japan.

Exclusion criteria

Exclusion Criteria:

  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
  • Have known or ongoing psychiatric disorders.
  • Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children).
  • Have a history of fracture within 6 months prior to screening.
  • Have a history of fainting.
  • Regularly use known drugs of abuse or with positive drug results.
  • Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation.
04

Study design

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

Study arms

  • Experimental
    LY4226695 Part A

    Participants will receive LY4226695 or placebo administered subcutaneously (SC)

    Drug: LY4226695 · Drug: Placebo

  • Experimental
    LY4226695 Part B

    Participants will receive LY4226695 or placebo administered SC

    Drug: LY4226695 · Drug: Placebo

  • Experimental
    LY4226695 Part C

    Participants will receive LY4226695 or placebo administered SC

    Drug: LY4226695 · Drug: Placebo

  • Experimental
    LY4226695 Part D

    Participants will receive LY4226695 administered intravenously (IV)

    Drug: LY4226695

Interventions

  • DrugLY4226695

    Administered SC

  • DrugLY4226695

    Administered IV

  • DrugPlacebo

    Administered SC

05

What researchers measure

Primary outcomes

  1. 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 through Day 57

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4226695

    Time frame: Baseline through Day 57

  2. PK: Maximum Concentration (Cmax) of LY4226695

    Time frame: Baseline through Day 57

06

Study locations

1 of 2 sites recruiting
  • CenExel ACT
    Anaheim, California 92801, United States
    • · Contact · 714-774-7777
    • Amina Haggag · Principal investigator
    Not yet recruiting
  • Lilly Centre for Clinical Pharmacology
    Singapore, 138623, Singapore
    • · Contact · 64139811
    • Jennifer Boon Wee · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07767487
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Aug 27, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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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