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A Study of Multiple Doses of LY3305677 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03325387
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Drug: LY3305677 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
Actual Study Start Date : October 27, 2017
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 3, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325387


Locations
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, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03325387     History of Changes
Other Study ID Numbers: 16619
I8P-MC-OXAB ( Other Identifier: Eli Lilly and Company )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No