A Study of LY3041658 in Healthy Participants

NCT04653168 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17745I7P-MC-DSAE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Number of Participants With incidence and severity of ISR

  Baseline up to Day 15

• Visual Analog Scale (VAS) Score for Injection Site Pain

  VAS Score for Injection Site Pain

  Baseline up to Day 1

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (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

  Predose up to day 85 postdose

Study Arms (2)

LY3041658 Low Dose

EXPERIMENTAL

LY3041658 administered by subcutaneous (SC) injection.

Drug: LY3041658

LY3041658 High Dose

EXPERIMENTAL

LY3041658 administered by SC injection.

Drug: LY3041658

Interventions

LY3041658 DRUG

Administered SC

LY3041658 High Dose; LY3041658 Low Dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 4, 2020
• Study Start: December 7, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06-15

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)