A Study of Multiple Doses of LY3305677 in Healthy Participants

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects

The purposes of this study are to determine:

• The safety of LY3305677 and any side effects that might be associated with it.
• How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin.
• The effect LY3305677 has on the body, particularly the effect on blood glucose levels.

This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study.

This study is for research purposes only and is not intended to treat any medical conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3305677; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LH
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination
• Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
• Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan
• Have a body weight of more than 54 kilograms (kg)

Exclusion Criteria:

• Currently enrolled in a clinical study or have participated in a study within the past 3 months
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
• Have history of pancreatitis
• Have known or ongoing psychiatric disorders
• Have undergone bariatric surgery or have used any drugs for weight loss
• Have a history of alcoholism
• Currently smoke more than 10 cigarettes a day

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3305677; Escalating doses of LY3305677 administered by subcutaneous (SC) injection	Drug: LY3305677; Administered SC
PLACEBO_COMPARATOR: Placebo; Saline solution administered by SC injection	Drug: Placebo; Administered SC

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 115 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677	PK: Cmax of LY3305677	Days 1 and 29: Predose through 168 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677	PK: AUC of LY3305677	Days 1 and 29: Predose through 168 hours post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2017
• Primary Completion (ACTUAL): August 3, 2018
• Study Completion (ACTUAL): August 3, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16619; I8P-MC-OXAB (OTHER: Eli Lilly and Company)

Drug and device information, study documents

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