A Study of Multiple Doses of LY3305677 in Healthy Participants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03325387|
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : August 16, 2018
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|
|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|
Escalating doses of LY3305677 administered by subcutaneous (SC) injection
Placebo Comparator: Placebo
Saline solution administered by SC injection
- 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
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677 [ Time Frame: 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 [ Time Frame: Days 1 and 29: Predose through 168 hours post dose ]PK: AUC of LY3305677
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
|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|
|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|