A Study of LY3143753 and LY3185643 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo (Part A and Part B); Drug: LY3143753 (Part A); Drug: rGlucagon (Part B); Drug: LY3185643 (Part B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02342314

15503

I7U-MC-GAHA (Other Identifier)

Details and patient eligibility

About

The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy males or females
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion criteria

• Are investigator site personnel directly affiliated with this study and their immediate families
• Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
• Have participated, within the last 3 months, in a clinical trial
• Have known or ongoing psychiatric disorders
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C and/or positive hepatitis C antibody
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen
• History of/current phaeochromocytoma
• History of/current insulinoma

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

68 participants in 5 patient groups, including a placebo group

LY3143753 (Part A)

Experimental group

Description:

Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1

Treatment:

Drug: LY3143753 (Part A)

LY3185643 (Part B)

Experimental group

Description:

Single SC injection of ascending doses of LY3185643 on Day 1

Treatment:

Drug: LY3185643 (Part B)

Placebo (Part A)

Placebo Comparator group

Description:

Single SC injection of normal saline on Day 1

Treatment:

Drug: Placebo (Part A and Part B)

rGlucagon (Part B)

Active Comparator group

Description:

Single SC injection on Day 1

Treatment:

Drug: rGlucagon (Part B)

Placebo (Part B)

Placebo Comparator group

Description:

Single SC injection of normal saline on Day 1

Treatment:

Drug: Placebo (Part A and Part B)