A Study of LY3848575 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3848575

• Registration Number: NCT05727072
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-05
• Study Start: 2023-02-10
• Study First Posted: 2023-02-14
• Primary Completion: 2024-02-19
• Study Completion: 2024-02-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Participants who are overtly healthy as determined by medical evaluation
• Have body weight of at least 50 kilograms (kg) for males and 40 kg for females, and body mass index of 18 to 30 kilograms per meter squared (kg/m²), inclusive
• For cohorts with Japanese participants: To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Exclusion Criteria

• Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have participated, within the last 3 months, in a clinical study involving an IP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo IV	Placebo	Placebo administered IV.
Placebo SC	Placebo	Placebo administered SC.
LY3848575 IV	LY3848575	Single ascending doses of LY3848575 administered intravenously (IV).
LY3848575 SC	LY3848575	Multiple doses of LY3848575 administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through 142 days	A summary of TEAEs, SAEs and Other Non-serious Adverse Events (AEs), Regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3848575 When Administered IV.	End of infusion through day 85	PK: AUC of LY3848575 When Administered IV.
PK: AUC of LY3848575 When Administered SC.	Predose through day 85	PK: AUC of LY3848575 When Administered SC.

Trial Locations

Locations (1)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States