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OpenTrials
Completed

NCT Number: NCT03325387

A Study of Multiple Doses of LY3305677 in Healthy Participants

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.

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Key information

Conditions

Healthy

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, West Yorkshire, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

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 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 outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677

    Time frame: Days 1 and 29: Predose through 168 hours post dose

    PK: Cmax of LY3305677

  2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677

    Time frame: Days 1 and 29: Predose through 168 hours post dose

    PK: AUC of LY3305677

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2017
Registry last updated
Aug 16, 2018

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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