A Study of LY3192767 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3192767; Drug: Basal Insulin Peglispro; Drug: Placebo; Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03025009

I8M-MC-BIXA (Other Identifier)

2016-003274-40 (EudraCT Number)

16242

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 5 patient groups, including a placebo group

LY3192767 (Part A)

Experimental group

Description:

Escalating doses of LY3192767 administered subcutaneously (SC).

Treatment:

Drug: LY3192767

Placebo (Part A)

Placebo Comparator group

Description:

Placebo matching LY3192767 administered subcutaneously (SC).

Treatment:

Drug: Placebo

LY3192767 (Part B)

Experimental group

Description:

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

Treatment:

Drug: LY3192767

Basal Insulin Peglispro (Part B)

Active Comparator group

Description:

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

Treatment:

Drug: Basal Insulin Peglispro

Insulin Glargine (Part B)

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Glargine