A Study of Remternetug (LY3372993) in Healthy Participants

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Drug: Remternetug (Test); Drug: Remternetug (Reference)

• Registration Number: NCT07056309
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate to different formulations of remternetug after single subcutaneous (SC) administration with either an autoinjector (AI) or a prefilled syringe (PFS). The study will look at the amount of remternetug that gets into the bloodstream and how long it takes the body to get rid of the remternetug when given as two different formulations.

Participation in the study will last approximately 155 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-24
• Study First Submitted: 2025-06-24
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Have a body mass index within the range of 18.0 to 34.0 kilograms per meter squared (kg/m2) (inclusive).

Exclusion Criteria

• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study drug or of interfering with the interpretation of data.
• Have evidence of significant active neuropsychiatric disease, as determined by the investigator.
• Have a personal or family history of early onset AD (AD diagnosed prior to 65 years of age).
• Contraindication to MRI, including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemakers.
• Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, with the exception of vitamin/mineral supplements, any hormone replacement therapy, and/or thyroid replacement therapy, within 7 days prior to dosing and for the duration of the study.
• Have a brain MRI that demonstrates any clinically significant findings that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remternetug (Test)	Remternetug (Test)	Remternetug administered subcutaneously (SC) via autoinjector (AI)
Remternetug (Reference)	Remternetug (Reference)	Remternetug administered SC via prefilled syringe.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK): Maximum Concentration (Cmax) of Remternetug	Predose up to Day 85
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve from Zero to time t [AUC(0-t)] of Remternetug	Predose up to Day 85
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity [AUC(0-inf)] of Remternetug	Predose up to Day 85

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK): Time of Maximum Concentration (tmax) of Remternetug	Predose up to Day 85

Trial Locations

Locations (2)

Fortrea Clinical Research Unit; 🇺🇸 Dallas, Texas, United States

QPS Missouri; 🇺🇸 Springfield, Missouri, United States