A Study of LY3556050 in Healthy Participants

Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects

The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3556050; Drug: Metformin; Drug: Iohexol

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males or females of nonchild bearing potential, as determined by medical history
• Have safety laboratory results within normal references ranges
• Weight at least 50 kilograms (kg)

Exclusion Criteria:

• Have known allergies to LY3556050, iodine, metformin and related compounds
• Abnormal electrocardiogram (ECG) or blood pressure at screening
• Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
• Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3556050 (Part A); LY3556050 administered orally.	Drug: LY3556050; Administered orally.
PLACEBO_COMPARATOR: Placebo (Part A); Placebo administered orally.	Drug: Placebo; Administered orally.
OTHER: Iohexol (Part B); Iohexol given intravenously (IV). (Part B is optional.)	Drug: Iohexol; Administered IV.
OTHER: Metformin (Part B); Metformin given orally. (Part B is optional.)	Drug: Metformin; Administered orally.
EXPERIMENTAL: LY3556050+ Iohexol (Part B); Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)	Drug: LY3556050; Administered orally.; Drug: Iohexol; Administered IV.
EXPERIMENTAL: LY3556050 + Metformin (Part B); Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)	Drug: LY3556050; Administered orally.; Drug: Metformin; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Final Follow-up (up to Week 9)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050	PK: Cmax of LY3556050	Baseline through Day 17
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)	PK: AUCτ of LY3556050	Baseline through Day 17

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2019
• Primary Completion (ACTUAL): August 3, 2020
• Study Completion (ACTUAL): August 3, 2020

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (ACTUAL): November 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 15, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 17612; J2P-MC-LXBA (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No