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OpenTrials
Completed

NCT Number: NCT07030127

A Study of LY3985863 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3985863

Drug

Administered SC

Placebo

Drug

Administered SC

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

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863

    Time frame: Predose on Day 1 up to Approximately Week 8 Post Dose

    PK: Cmax of LY3985863

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

    Time frame: Predose on Day 1 up to Approximately Week 8 Post Dose

    PK: AUC of LY3985863

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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