A Study of LY3041658 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3041658

• Registration Number: NCT04653168
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2020-12-07
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-06-15
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3041658 High Dose	LY3041658	LY3041658 administered by SC injection.
LY3041658 Low Dose	LY3041658	LY3041658 administered by subcutaneous (SC) injection.

Primary Outcome Measures

Name	Time	Method
Number of Participants With incidence and severity of Injection Site Reaction (ISR)	Baseline up to Day 15	Number of Participants With incidence and severity of ISR
Visual Analog Scale (VAS) Score for Injection Site Pain	Baseline up to Day 1	VAS Score for Injection Site Pain

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658	Predose up to day 85 postdose	PK: Cmax of LY3041658
PK: Area Under the Concentration Versus Time Curve (AUC) from time 0 to infinity of LY3041658	Predose up to day 85 postdose	PK: AUC(0-inf) of LY3041658

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore