NCT07056309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2025

Typical duration for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

June 24, 2025

Last Update Submit

January 21, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Pharmacokinetic (PK): Time of Maximum Concentration (tmax) of Remternetug

    Predose up to Day 85

Study Arms (2)

Remternetug (Test)

EXPERIMENTAL

Remternetug administered subcutaneously (SC) via autoinjector (AI)

Drug: Remternetug (Test)

Remternetug (Reference)

EXPERIMENTAL

Remternetug administered SC via prefilled syringe.

Drug: Remternetug (Reference)

Interventions

Remternetug (Test)DRUG

Administered SC

Also known as: LY3372993
Remternetug (Test)
Remternetug (Reference)DRUG

Administered SC

Also known as: LY3372993
Remternetug (Reference)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

QPS Missouri

Springfield, Missouri, 65802, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 9, 2025

Study Start

June 24, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)