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
1040 North Mason Road
Saint Louis, Missouri 63141
Principal Investigator: Timothy Jennings
Phone: 636-220-1200
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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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Fargo, ND
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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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Methuen, Massachusetts 01844
Principal Investigator: Michael McCartney
Phone: 978-655-7155
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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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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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