A Study of LY3192767 in Healthy Participants

A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects

The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3192767; Drug: Placebo; Drug: Basal Insulin Peglispro; Drug: Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Neuss, Nordrhein-Westfalen, Germany, 41460
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination
• Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive

Exclusion Criteria:

• Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
• Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
• Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3192767 (Part A); Escalating doses of LY3192767 administered subcutaneously (SC).	Drug: LY3192767; Administered SC.
Placebo Comparator: Placebo (Part A); Placebo matching LY3192767 administered subcutaneously (SC).	Drug: Placebo; Administered SC.
Experimental: LY3192767 (Part B); LY3192767 administered as a SC injection in one of three study periods.	Drug: LY3192767; Administered SC.
Active Comparator: Basal Insulin Peglispro (Part B); Basal insulin peglispro administered as a SC injection in one of three study periods.	Drug: Basal Insulin Peglispro; Administered SC.; Other Names: LY2605541
Active Comparator: Insulin Glargine (Part B); Insulin glargine administered as a SC injection in one of three study periods.	Drug: Insulin Glargine; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Study Completion (up to about Day 49)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767	PK: Tmax of LY3192767	Predose through 336 Hours
PK: Maximum Serum Concentration (Cmax) of LY3192767	PK: Cmax of LY3192767	Predose through 336 Hours
PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767	PK: AUC(0-inf) of LY3192767	Predose through 336 Hours
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767	PD: Total Amount of Glucose Infused (Gtot) of LY3192767	Predose through 36 Hours During Clamp Procedure
PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767	PD: Rmax of LY3192767	Predose through 36 Hours During Clamp Procedure
PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767	PD: TRmax of LY3192767	Predose through 36 Hours During Clamp Procedure
PD: Change from Baseline in Free Fatty Acids	PD: Change from Baseline in Free Fatty Acids	Predose through 48 Hours Postdose
PD: Change from Baseline in Glycerol	PD: Change from Baseline in Glycerol	Predose through 48 Hours Postdose
PD: Change from Baseline in Triglycerides	PD: Change from Baseline in Triglycerides	Predose through 48 Hours Postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: 16242; I8M-MC-BIXA (Other Identifier: Eli Lilly and Company); 2016-003274-40 (EudraCT Number)

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