A Study of LY3985863 in Healthy Participants

NCT07030127 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27292J4Z-MC-GIDH
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

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

  Baseline to Study Completion (Up to 19 Weeks)

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863

  Predose on Day 1 up to Approximately Week 8 Post Dose

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863

  Predose on Day 1 up to Approximately Week 8 Post Dose

Study Arms (2)

LY3985863

EXPERIMENTAL

Administered subcutaneously (SC)

Drug: LY3985863

Placebo

PLACEBO COMPARATOR

Administered SC

Drug: Placebo

Interventions

LY3985863 DRUG

Administered SC

LY3985863

Placebo DRUG

Administered SC

Placebo

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

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

Study Design

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

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: August 11, 2025
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)