A Study of LY4088044 in Healthy Participants

NCT07090785 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27275J5S-MC-CEAA
• Study Type: interventional
• Target: 104
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Healthy

Outcome Measures

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

  A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Approximately Day 190

Secondary Outcomes (3)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044

  Baseline up to Approximately Day 190

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044

  Baseline up to Approximately Day 190

• Pharmacodynamics (PD): Protein Levels in Skin Samples

  Baseline up to Approximately Day 190

Study Arms (6)

LY4088044 (Part A)

EXPERIMENTAL

Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)

Drug: LY4088044

Placebo (Part A)

PLACEBO COMPARATOR

Administered IV

Drug: Placebo

LY4088044 (Part B)

EXPERIMENTAL

SAD of LY4088044 administered subcutaneously (SC)

Drug: LY4088044

Placebo (Part B)

PLACEBO COMPARATOR

Administered SC

Drug: Placebo

LY4088044 (Part C)

EXPERIMENTAL

Multiple-ascending doses (MAD) of LY4088044 administered IV

Drug: LY4088044

Placebo (Part C)

PLACEBO COMPARATOR

Administered IV

Drug: Placebo

Interventions

LY4088044 DRUG

Administered IV

LY4088044 (Part A); LY4088044 (Part C)

Placebo DRUG

Administered IV

Placebo (Part A); Placebo (Part C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

NOT YET RECRUITING

ICON

Lenexa, Kansas, 66219, United States

NOT YET RECRUITING

ICON Early Phase Services

San Antonio, Texas, 78232, United States

RECRUITING

ICON

Salt Lake City, Utah, 84124, United States

RECRUITING

New Zealand Clinical Research Christchurch

Christchurch, 8011, New Zealand

NOT YET RECRUITING

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

RECRUITING

Study Officials

• 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 DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor is blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 29, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (4); NZ (1)