A Study of LY4088044 in Healthy Participants

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: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: LY4088044; Drug: LY4088044

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• 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: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

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
      • Not yet recruiting
      • ICON
      • Principal Investigator: Patrick Yao
      • Contact: Phone Number: 913-205-4397
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

6

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

Collaborators and Investigators

• 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

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): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 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