LY3305677 SAD Study in Healthy Subjects
Research type
Research Study
Full title
A First-in-Human Single Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
IRAS ID
212249
Contact name
Jim Bush
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-002264-13
Duration of Study in the UK
0 years, 5 months, 25 days
Research summary
LY3305677 (study drug) is being tested as a potential treatment to treat high blood sugar in people with type 2 diabetes. LY3305677 is similar to a hormone called oxyntomodulin (OXM) that is naturally produced in the body by the small intestine. Oxyntomodulin has multiple beneficial effects on the way the body handles nutrients, which can help control the level of sugar in the blood after meals and help with weight loss.
This study is a Phase 1, single-site, single ascending dose (SAD) study in healthy subjects. This study will be the first time that LY3305677 is administered to humans.
Up to 6 dose levels of LY3305677 may be explored in this study.
At the beginning of the first dose level (Cohort 1), 1 subject will receive the Study Drug and 1 subject will receive placebo, and these subjects will be monitored for at least 5 days after dosing. The data from these first 2 subjects will be reviewed prior to dosing of the remaining 6 subjects at this dose level. Of the remaining 6 subjects, 5 will receive the Study Drug and 1 will receive placebo.
The dose level in each cohort (Cohorts 2 to 6) will be decided following review of the data from the previous dose level. Subjects will be dosed only after the safety data from the previous dose level has been reviewed, and the study physician is satisfied that it is safe to proceed with dosing at the next dose level.
The total study duration will be up to 16 weeks from the time of screening to the last follow-up visit.REC name
North East - York Research Ethics Committee
REC reference
16/NE/0284
Date of REC Opinion
12 Oct 2016
REC opinion
Favourable Opinion