A Study of LY3041658 in Healthy Participants

June 17, 2021 updated by: Eli Lilly and Company

A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3041658 Low Dose
LY3041658 administered by subcutaneous (SC) injection.
Drug: LY3041658
Administered SC
Experimental: LY3041658 High Dose
LY3041658 administered by SC injection.
Drug: LY3041658
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to Day 15
Visual Analog Scale (VAS) Score for Injection Site Pain
Time Frame: Baseline up to Day 1
VAS Score for Injection Site Pain
Baseline up to Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658
Time Frame: Predose up to day 85 postdose
PK: Cmax of LY3041658
Predose up to day 85 postdose
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
Predose up to day 85 postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2020

Primary Completion (Actual)

May 28, 2021

Study Completion (Actual)

May 28, 2021

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 15, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 17745
  • I7P-MC-DSAE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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