A Study of LY3192767 in Healthy Participants

NCT03025009 | Completed Phase 1 FDA Drug

• 3 other identifiers: 16242I8M-MC-BIXA2016-003274-40
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767

  Predose through 336 Hours

• PK: Maximum Serum Concentration (Cmax) of LY3192767

  Predose through 336 Hours

• PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767

  Predose through 336 Hours

• Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767

  Predose through 36 Hours During Clamp Procedure

• PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767

  Predose through 36 Hours During Clamp Procedure

Study Arms (5)

LY3192767 (Part A)

EXPERIMENTAL

Escalating doses of LY3192767 administered subcutaneously (SC).

Drug: LY3192767

Placebo (Part A)

PLACEBO COMPARATOR

Placebo matching LY3192767 administered subcutaneously (SC).

Drug: Placebo

LY3192767 (Part B)

EXPERIMENTAL

LY3192767 administered as a SC injection in one of three study periods.

Drug: LY3192767

Basal Insulin Peglispro (Part B)

ACTIVE COMPARATOR

Basal insulin peglispro administered as a SC injection in one of three study periods.

Drug: Basal Insulin Peglispro

Insulin Glargine (Part B)

ACTIVE COMPARATOR

Insulin glargine administered as a SC injection in one of three study periods.

Drug: Insulin Glargine

Interventions

LY3192767 DRUG

Administered SC.

LY3192767 (Part A); LY3192767 (Part B)

Basal Insulin Peglispro DRUG

Administered SC.

Also known as: LY2605541

Basal Insulin Peglispro (Part B)

Insulin Glargine DRUG

Administered SC.

Insulin Glargine (Part B)

Placebo DRUG

Administered SC.

Placebo (Part A)

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Interventions

basal insulin peglispro; LY2605541; Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: March 6, 2017
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)