A Study of LY3985863 in Healthy Participants

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: LY3985863; Drug: Placebo

• Registration Number: NCT07030127
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-08-01
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Are native Chinese participants
• Are overtly healthy
• Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive
• Have a stable body weight within 3 months

Exclusion Criteria

• Have known allergies to any components of the LY3985863 formulation
• Have concomitant disease known to influence skeletal muscle protein
• Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data
• Have a 12-lead echocardiogram (ECG) abnormality
• Have used within 3 months or intend to use medications during the study that promote weight loss

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3985863	LY3985863	Administered subcutaneously (SC)
Placebo	Placebo	Administered 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 to Study Completion (Up to 19 Weeks)	A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863	Predose on Day 1 up to Approximately Week 8 Post Dose	PK: Cmax of LY3985863
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863	Predose on Day 1 up to Approximately Week 8 Post Dose	PK: AUC of LY3985863

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China