Overview

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Status:
Completed
Trial end date:
2018-04-24
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Tirzepatide
Criteria
Inclusion Criteria:

- Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing
Type 2 Diabetes Mellitus (American Diabetes Association 2017).

- Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

- If on metformin, have been treated with stable doses of metformin for at least 3
months.

- Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.

Exclusion Criteria:

- Have type 1 diabetes (T1D).

- Have used any glucose-lowering medication other than metformin within 3 months prior
to study entry or during screening/lead-in period or have used any glucagon-like
peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.

- Have had any of the following cardiovascular conditions: acute myocardial infarction
(MI), New York Heart Association Class III or Class IV heart failure, or
cerebrovascular accident (stroke).

- Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
>2.5 times the upper limit of the reference range, as determined by the central
laboratory at study entry; participants with NAFLD are eligible for participation in
this trial.

- Have had chronic or acute pancreatitis any time prior to study entry.

- Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

- Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
laboratory at study entry.

- Have any condition that is a contraindication for use of the GLP-1 RA class (per
country-specific labels) at study entry or develop such condition between study entry
and randomization.