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OpenTrials
Completed

NCT Number: NCT04653168

A Study of LY3041658 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3041658 in healthy participants. The study will measure how the body absorbs, breaks down and gets rid of LY3041658.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive).

Exclusion criteria

  • Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data.
  • Have self-perceived dullness or loss of sensation on either side of their abdomen.
  • Have any condition that could affect pain perception from an injection.
  • Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.

Treatment and study plan

LY3041658

Drug

Administered SC

Primary outcomes

  1. Number of Participants With incidence and severity of Injection Site Reaction (ISR)

    Time frame: Baseline up to Day 15

    Number of Participants With incidence and severity of ISR

  2. Visual Analog Scale (VAS) Score for Injection Site Pain

    Time frame: Baseline up to Day 1

    VAS Score for Injection Site Pain

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658

    Time frame: Predose up to day 85 postdose

    PK: Cmax of LY3041658

  2. PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658

    Time frame: Predose up to day 85 postdose

    PK: AUC(0-inf) of LY3041658

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 4, 2020
Registry last updated
Jun 18, 2021

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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