A Study of LY3192767 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3192767; Drug: Placebo; Drug: Basal Insulin Peglispro; Drug: Insulin Glargine

• Registration Number: NCT03025009
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Study Start: 2017-03-06
• Primary Completion: 2018-04-11
• Study Completion: 2018-04-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3192767 (Part A)	LY3192767	Escalating doses of LY3192767 administered subcutaneously (SC).
Placebo (Part A)	Placebo	Placebo matching LY3192767 administered subcutaneously (SC).
LY3192767 (Part B)	LY3192767	LY3192767 administered as a SC injection in one of three study periods.
Basal Insulin Peglispro (Part B)	Basal Insulin Peglispro	Basal insulin peglispro administered as a SC injection in one of three study periods.
Insulin Glargine (Part B)	Insulin Glargine	Insulin glargine administered as a SC injection in one of three study periods.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (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, Nordrhein-Westfalen, Germany