A Study of LY3041658 in Healthy Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04653168

Enrollment

Registered

2020-12-04

Start date

2020-12-07

Completion date

2021-05-28

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLY3041658

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026