A Study of Multiple Doses of LY3305677 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3305677; Drug: Placebo

• Registration Number: NCT03325387
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-10-26
• Study Start: 2017-10-27
• Study First Posted: 2017-10-30
• Status Verified: 2018-08
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3305677	LY3305677	Escalating doses of LY3305677 administered by subcutaneous (SC) injection
Placebo	Placebo	Saline solution administered by SC injection

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through 115 days	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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.; 🇬🇧 Leeds, West Yorkshire, United Kingdom