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Completed

NCT Number: NCT03025009

A Study of LY3192767 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3192767

Drug

Administered SC.

Basal Insulin Peglispro

Drug

Administered SC.

Other names: LY2605541

insulin glargine

Drug

Administered SC.

Placebo

Drug

Administered SC.

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

    Time frame: 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 outcomes

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

    Time frame: Predose through 336 Hours

    PK: Tmax of LY3192767

  2. PK: Maximum Serum Concentration (Cmax) of LY3192767

    Time frame: Predose through 336 Hours

    PK: Cmax of LY3192767

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

    Time frame: Predose through 336 Hours

    PK: AUC(0-inf) of LY3192767

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

    Time frame: Predose through 36 Hours During Clamp Procedure

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

  5. PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767

    Time frame: Predose through 36 Hours During Clamp Procedure

    PD: Rmax of LY3192767

  6. PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767

    Time frame: Predose through 36 Hours During Clamp Procedure

    PD: TRmax of LY3192767

  7. PD: Change from Baseline in Free Fatty Acids

    Time frame: Predose through 48 Hours Postdose

    PD: Change from Baseline in Free Fatty Acids

  8. PD: Change from Baseline in Glycerol

    Time frame: Predose through 48 Hours Postdose

    PD: Change from Baseline in Glycerol

  9. PD: Change from Baseline in Triglycerides

    Time frame: Predose through 48 Hours Postdose

    PD: Change from Baseline in Triglycerides

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 19, 2017
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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