A Study of LY3041658 in Healthy Participants

• ClinicalTrials.gov Identifier: NCT04653168
• Recruitment Status: Active, not recruiting
• First Posted: December 4, 2020
• Last Update Posted: March 19, 2021
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: December 3, 2020
• First Posted Date: December 4, 2020
• Last Update Posted Date: March 19, 2021
• Actual Study Start Date: December 7, 2020
• Estimated Primary Completion Date: May 24, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 3, 2020)

• 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
• Visual Analog Scale (VAS) Score for Injection Site Pain [ Time Frame: Baseline up to Day 1 ]
  VAS Score for Injection Site Pain

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 3, 2020)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658 [ Time Frame: 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 [ Time Frame: Predose up to day 85 postdose ]
  PK: AUC(0-inf) of LY3041658

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of LY3041658 in Healthy Participants
• Official Title: A Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Injections of LY3041658 in Healthy Participants
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Drug: LY3041658

Administered SC

Study Arms

• Experimental: LY3041658 Low Dose
  LY3041658 administered by subcutaneous (SC) injection.
  Intervention: Drug: LY3041658
• Experimental: LY3041658 High Dose
  LY3041658 administered by SC injection.
  Intervention: Drug: LY3041658

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 3, 2020): 16
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 24, 2021
• Estimated Primary Completion Date: May 24, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT04653168
• Other Study ID Numbers: 17745; I7P-MC-DSAE ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Eli Lilly and Company
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: 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

• PRS Account: Eli Lilly and Company
• Verification Date: March 15, 2021