A Study of LY3298176 in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Status:	Completed
Conditions:	Healthy Studies, Diabetes, Diabetes
Therapuetic Areas:	Endocrinology, Other
Healthy:	No
Age Range:	21 - 70
Updated:	6/30/2017
Start Date:	May 11, 2016
End Date:	June 26, 2017

A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus

The main purposes of this study are to determine:

- The safety of LY3298176 and any side effects that might be associated with it.

- How much LY3298176 gets into the bloodstream and how long it takes the body to get rid
of it.

- How LY3298176 affects the levels of blood sugar.

This study includes 3 parts (A, B and C). Part A involves a single dose of LY3298176 taken
as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in
duration, including screening. Parts B and C involve 4 doses of LY3298176 taken once weekly
(over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in
duration, including screening. Each participant will enroll in only one part.

This study is for research purposes only, and is not intended to treat any medical
condition.

Inclusion Criteria:

- Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1
year before enrollment (Part C)

- Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to
40.0 kilograms per meter squared (kg/m²), inclusive

- Participants with T2DM (Part C only): have T2DM controlled with diet and exercise
alone or are stable on a single oral antidiabetic medication (metformin for at least
30 days or sulfonylureas). Participants receiving sulfonylureas may participate only
if this treatment is stopped for at least 6 weeks before dosing with study drug

Exclusion Criteria:

- Have known allergies to LY3298176, glucagon-like peptide (GLP)-1 analogs, or related
compounds

- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the
opinion of the investigator, increases the risks associated with participating in the
study

- Have a history or presence of pancreatitis (history of chronic pancreatitis or
idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than
2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for
example, relevant esophageal reflux or gall bladder disease) or any GI disease which
impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with
the exception of appendectomy) or could be aggravated by glucagon-like peptide-1
(GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors

Participants with T2DM (Part C only)

- Have had more than 1 episode of severe hypoglycemia, as defined by the American
Diabetes Association criteria, within 6 months before entry into the study or has a
history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

All Study Participants (Parts B and C only)

- have known allergies to LY3298176, GLP-1 analogs, or related compounds, or
acetaminophen

We found this trial at

sites

Miami Research Associates

6141 Sunset Dr # 301
South Miami, Florida 33143

(305) 598-3125