A Study of LY4088044 in Healthy Participants

August 6, 2026 updated by: Eli Lilly and Company

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.

The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • New Zealand
      • Christchurch, New Zealand, 8011
        • Not yet recruiting
        • New Zealand Clinical Research Christchurch
        • Principal Investigator:
          • Chris Wynne
  • Singapore
      • Singapore, Singapore, 138623
        • Recruiting
        • Lilly Centre for Clinical Pharmacology
        • Contact:
          • Phone Number: +65 6413 9811
        • Principal Investigator:
          • Jeffer Hann Wei Pang
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Collaborative Neuroscience Network - CNS
        • Principal Investigator:
          • Steven Reynolds
        • Contact:
          • Phone Number: 844-424-9494
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Suspended
        • ICON
    • Texas
      • San Antonio, Texas, United States, 78232
        • Recruiting
        • ICON Early Phase Services
        • Principal Investigator:
          • Chinonye Ogbonnaya-Odor
        • Contact:
          • Phone Number: 210-283-4156
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • ICON
        • Contact:
          • Phone Number: 801-269-8200
        • Principal Investigator:
          • Ahad Sabet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
  • Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)

Exclusion Criteria:

  • Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating
  • Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history
  • Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy
  • Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²)
  • Have a 12-lead electrocardiogram (ECG) abnormality
  • Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions
  • Have an average weekly alcohol intake that exceeds 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY4088044 (Part A)
Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)
Drug: LY4088044
Administered IV
Drug: LY4088044
Administered SC
Placebo Comparator: Placebo (Part A)
Administered IV
Drug: Placebo
Administered SC
Drug: Placebo
Administered IV
Experimental: LY4088044 (Part B)
SAD of LY4088044 administered subcutaneously (SC)
Drug: LY4088044
Administered IV
Drug: LY4088044
Administered SC
Placebo Comparator: Placebo (Part B)
Administered SC
Drug: Placebo
Administered SC
Drug: Placebo
Administered IV
Experimental: LY4088044 (Part C)
Multiple-ascending doses (MAD) of LY4088044 administered IV
Drug: LY4088044
Administered IV
Drug: LY4088044
Administered SC
Placebo Comparator: Placebo (Part C)
Administered IV
Drug: Placebo
Administered SC
Drug: Placebo
Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Approximately Day 190
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Baseline up to Approximately Day 190

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044
Time Frame: Baseline up to Approximately Day 190
PK: Cmax of LY4088044
Baseline up to Approximately Day 190
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044
Time Frame: Baseline up to Approximately Day 190
PK: AUC of LY4088044
Baseline up to Approximately Day 190
Pharmacodynamics (PD): Protein Levels in Skin Samples
Time Frame: Baseline up to Approximately Day 190
PD: Percent Decrease in Protein Levels
Baseline up to Approximately Day 190

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 9, 2025

First Submitted That Met QC Criteria

July 28, 2025

First Posted (Actual)

July 29, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 27275
  • J5S-MC-CEAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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