A study to examine LY3305677 in healthy subjects
Research type
Research Study
Full title
A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
IRAS ID
230465
Contact name
Jim Bush
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-001573-17
Duration of Study in the UK
0 years, 9 months, 0 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 will be the second time LY3305677 is given to humans. Forty-seven healthy participants (including 19 Japanese participants) have received LY3305677 in the first-in-human study at our unit.
This study will include 4 main cohorts. Each cohort will have 14 participants. Two additional cohorts may be included if required and the dose level will not exceed 1.0 mg (each with 14 participants). There will be 4 fixed-dose levels of LY3305677 investigated in this study. Participants will receive a fixed-dose level of LY3305677 or placebo once weekly for 4 weeks. The doses will be administered via subcutaneous injection into the abdomen.
The dose level in each subsequent cohort will be decided following review of the data from at least 8 participants from the previous dose level.The total study duration will be up to 20 weeks from the time of screening to the last follow-up visit.
REC name
Wales REC 2
REC reference
17/WA/0283
Date of REC Opinion
14 Sep 2017
REC opinion
Favourable Opinion