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OpenTrials
Completed

NCT Number: NCT02972645

A Study of LY3305677 in Healthy Participants

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.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, LS2-9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3305677

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline to Study Completion (approximately 16 weeks)

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677

    Time frame: Day 1 Pre-dose through Day 85

  2. Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677

    Time frame: Day 1 Pre-dose through Day 85

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2016
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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