Overview

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Status:
Recruiting
Trial end date:
2022-08-17
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 30 weeks.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Dulaglutide
Criteria
Inclusion Criteria:

- Have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of
metformin

- Have a stable body weight for the 3 months prior to randomization

- Have a body mass index (BMI) ≥23 kilogram/square meter (kg/m²)

- Males must agree to use highly effective methods of contraception

- Women not of childbearing potential (WNOCBP) may participate in this trial

- Note: Hormone replacement therapy in post-menopausal women is allowed but women must
be on stable therapy for 3 months prior to day 1.

Exclusion Criteria:

- Have Type 1 diabetes mellitus (T1DM) or history of ketoacidosis or hyperosmolar coma

- Have a history of diabetic retinopathy, diabetic maculopathy, or severe
non-proliferative diabetic retinopathy that requires immediate treatment intervention

- Have had more than 1 episode of severe hypoglycemia and aware of hypoglycemic symptoms

- Have acute or chronic pancreatitis

- Have obesity induced other endocrine disorders (Cushing's syndrome or Prader - Willi
syndrome)

- Have gastric emptying abnormality or chronically take medications impacting GI
motility

- Have poorly controlled hypertension

- Have the following heart conditions within the last 6 months: myocardial infarction
(MI), unstable angina, coronary artery bypass graft, percutaneous coronary
intervention (diagnostic angiograms are permitted), transient ischemic attack (TIA),
cerebrovascular accident (stroke)or decompensated congestive heart failure, or IV
heart failure

- Have any symptoms of other liver diseases besides nonalcoholic fatty liver disease
(NAFLD)

- Have HIV, or Hepatitis B or Hepatitis C