Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief summary:
The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:
This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.

Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.

The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.

Arms:
arm 1: LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 2: LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 3: LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 4: LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 5: LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 6: LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1 arm 7: Placebo: saline, subcutaneous (SC) injection, single dose on Day 1

Interventions: intervention 1: LY3009385 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: