A Study of LY3305677 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972645
• Other study ID #: 16350
• Secondary ID: I8P-MC-OXAA
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2016
• Last updated: July 21, 2017
• Start date: December 5, 2016
• Est. completion date: July 14, 2017

Study information

• Verified date: July 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.

This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.

This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).

Participation in this study is expected to last up to 16 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Overtly healthy as determined by medical history and physical examination

• Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product

• Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause

• First generation Japanese participants or non-Japanese participants

• Have a body weight of more than 50 kilograms (kg)

Exclusion Criteria:

• Have participated within the last 3 months in a clinical trial involving an investigational product

• Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy

• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1

• Have undergone any form of bariatric surgery

• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis

• Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase

• Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C

• Have used or intend to use medications that promote weight loss

• Have donated blood of more than 500 milliliter (mL) within the last month

• Currently smoke more than 10 cigarettes per day

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3305677
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) considered by the Investigator to be Related to Study Drug Administration		Baseline to Study Completion (approximately 16 weeks)
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677		Day 1 Pre-dose through Day 85
Secondary	Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677		Day 1 Pre-dose through Day 85