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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:3/14/2019
Start Date:May 24, 2017
End Date:March 28, 2018

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A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in
participants with type 2 diabetes mellitus.


Inclusion Criteria:

- Have had type 2 diabetes (T2D) for ≥6 months according to the World Health
Organization (WHO) classification.

- 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) ≥23 and <50 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.

- 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.
We found this trial at
36
sites
Methuen, Massachusetts 01844
Principal Investigator: Michael McCartney
Phone: 978-655-7155
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Principal Investigator: Mae Sheikh- Ali
Phone: 904-244-3088
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Jacksonville, FL
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan Frias
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Los Angeles, CA
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
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1085 North Harbor Boulevard
Anaheim, California 92801
Principal Investigator: Amina Haggag
Phone: 714-774-7777
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Columbus, Ohio 43213
Principal Investigator: Samir Arora
Phone: 614-501-6164
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801 Monterey Street
Coral Gables, Florida 33134
Principal Investigator: Jeffrey Rosen
Phone: 305-445-5637
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Corvallis, Oregon 97330
Principal Investigator: Michael Chen
Phone: 541-754-1398
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Dallas, Texas 75230
Principal Investigator: Julio Rosenstock
Phone: 972-566-7799
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Fargo, North Dakota 58103
Principal Investigator: Michael Lillestol
Phone: 701-232-7705
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Fresno, California 93720
Principal Investigator: Paul Norwood
Phone: 559-261-0992
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Huntington Park, California 90255
Principal Investigator: Stanley Hsia
Phone: 323-357-3633
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Knoxville, Tennessee 37923
Principal Investigator: Evelyne Davidson
Phone: 865-200-8364
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Knoxville, Tennessee 37912
Principal Investigator: Rickey Manning
Phone: 865-244-4276
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Las Vegas, Nevada 89102
Principal Investigator: Samer Nakhle
Phone: 702-826-2795
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Meridian, Idaho 83646
Principal Investigator: David Butuk
Phone: 208-288-0123
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2128 West Flagler Street
Miami, Florida 33135
Principal Investigator: Mark Kutner
Phone: 305-631-6704
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Miami, Florida 33175
Principal Investigator: Francisco Miranda
Phone: 305-226-3933
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Mobile, Alabama 36608
Principal Investigator: Allan Shain
Phone: 251-410-3046
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180 Wingo Way
Moncks Corner, South Carolina 29461
Principal Investigator: Gordon Wilhoit
Phone: 843-849-1880
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Montclair, California 91763
Principal Investigator: Gilbert Martinez
Phone: 909-445-8451
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New York, New York 10016
Principal Investigator: Susan Zweig
Phone: 212-480-3333
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18433 Roscoe Boulevard
Northridge, California 91325
Principal Investigator: Christopher Chow
Phone: 818-280-4220
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Ocoee, Florida 34761
Principal Investigator: Kelly Taylor
Phone: 407-654-2724
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3820 Tampa Road
Palm Harbor, Florida 34684
Principal Investigator: Aron Schlau
Phone: 727-785-4540
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736 South 900 East
Saint George, Utah 84790
Principal Investigator: Scott Barton
Phone: 435-656-1704
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1040 North Mason Road
Saint Louis, Missouri 63141
Principal Investigator: Timothy Jennings
Phone: 636-220-1200
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San Diego, California 92123
Principal Investigator: Purvi Mehra
Phone: 858-278-3647
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San Marcos, California 92078
Principal Investigator: Stacey Layle
Phone: 760-266-4144
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Shavano Park, Texas 78231
Principal Investigator: Michelle Welch
Phone: 210-545-4900
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Spring Valley, California 91978
Principal Investigator: Hanid Audish
Phone: 619-660-9068
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3520 Southwest 6th Avenue
Topeka, Kansas 66606
Principal Investigator: Alan Wynne
Phone: 785-368-0490
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Trenton, New Jersey 08611
Principal Investigator: Jane Rohlf
Phone: 609-392-6666
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Tustin, California 92780
Principal Investigator: Joanna Van
Phone: 714-760-9317
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1031 Office Park Road
West Des Moines, Iowa 50265
Principal Investigator: Anuj Bhargava
Phone: 515-643-5122
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