A Study of LY3192767 in Healthy Participants

NCT ID: NCT03025009

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-04-11

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3192767 (Part A)

Escalating doses of LY3192767 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3192767

Intervention Type DRUG

Administered SC.

Placebo (Part A)

Placebo matching LY3192767 administered subcutaneously (SC).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

LY3192767 (Part B)

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

Group Type EXPERIMENTAL

LY3192767

Intervention Type DRUG

Administered SC.

Basal Insulin Peglispro (Part B)

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

Group Type ACTIVE_COMPARATOR

Basal Insulin Peglispro

Intervention Type DRUG

Administered SC.

Insulin Glargine (Part B)

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

Group Type ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type DRUG

Administered SC.

Interventions

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LY3192767

Administered SC.

Intervention Type DRUG

Basal Insulin Peglispro

Administered SC.

Intervention Type DRUG

Insulin Glargine

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Other Intervention Names

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LY2605541

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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, Germany

Site Status

Countries

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Germany

Other Identifiers

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I8M-MC-BIXA

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003274-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16242

Identifier Type: -

Identifier Source: org_study_id

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