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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tirzepatide
Dulaglutide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Internal Medicine Center LLC
  • Anaheim Clinical Trails
  • Valley Research
  • National Research Institute
  • National Research Institute
  • Catalina Research Institute
  • Valley Clinical Trails, Inc
  • Artemis Institute For Clinical Research
  • Artemis Institute For Clinical Research
  • Encompass Clinical Research
  • University Clinical Investigators INC
  • Chase Medical Research
  • Clinical Research of South Florida
  • East Coast Institute For Research
  • Suncoast Research Group, LCC
  • New Horizon Research Center
  • Sensible Healthcare
  • Palm Harbor Medical Associate
  • Solaris Clinical Research
  • Iderc P.L.C.
  • Cotton O'Neil Diabetes and Endocrine
  • ActivMed Practices & Research
  • Clinical Research Professionals
  • Palm Research Center
  • Premier Research
  • Manhattan Medical Research
  • Lillestol Research LLC
  • Aventiv Research
  • The Corvallis Clinic P.C.
  • PMG Research Of Charleston LLC
  • New Phase Research & Development
  • PMG Research Of Knoxville
  • Dallas Diabetes Endocrine Center
  • Consano Clinical Research
  • Chrysalis Clinical Research
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • "For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician."
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
  • Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA
  • Manati Center for Clinical Research
  • Clinical Research Puerto Rico. Inc
  • GCM Medical Group PSC
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Placebo

1 mg Tirzepatide

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

1.5 mg Dulaglutide

Arm Description

Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.

1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.

Secondary Outcome Measures

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.
Change From Baseline to Week 26 in HbA1c
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Change From Baseline to Week 12 in HbA1c
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Change From Baseline in Body Weight
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Percentage of Participants With 5% or Greater Body Weight Loss From Baseline
Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.
Percentage of Participants With 10% or Greater Body Weight Loss From Baseline
Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.
Percentage of Participants Reaching the HbA1c Target of ≤6.5%
Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.
Percentage of Participants Reaching the HbA1c Target of <7.0%
Percentage of participants with HbA1c <7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.
Change From Baseline in Fasting Blood Glucose
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment*time.
Change From Baseline in Total Cholesterol
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Change From Baseline in Triglycerides
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Change From Baseline in Waist Circumference
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Number of Participants With Anti-Drug Antibodies
Number of Participants With Anti-Drug Antibodies.
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide

Full Information

First Posted
April 24, 2017
Last Updated
July 31, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03131687
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Official Title
A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
Arm Title
1 mg Tirzepatide
Arm Type
Experimental
Arm Description
1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Arm Title
1.5 mg Dulaglutide
Arm Type
Active Comparator
Arm Description
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
Intervention Type
Drug
Intervention Name(s)
tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
LY2189265
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
Description
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
Description
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.
Time Frame
Baseline, Week 12
Title
Change From Baseline to Week 26 in HbA1c
Description
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Time Frame
Baseline, Week 26
Title
Change From Baseline to Week 12 in HbA1c
Description
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Body Weight
Description
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Time Frame
Baseline, Week 26
Title
Percentage of Participants With 5% or Greater Body Weight Loss From Baseline
Description
Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.
Time Frame
Week 26
Title
Percentage of Participants With 10% or Greater Body Weight Loss From Baseline
Description
Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.
Time Frame
Week 26
Title
Percentage of Participants Reaching the HbA1c Target of ≤6.5%
Description
Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.
Time Frame
Week 26
Title
Percentage of Participants Reaching the HbA1c Target of <7.0%
Description
Percentage of participants with HbA1c <7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.
Time Frame
Week 26
Title
Change From Baseline in Fasting Blood Glucose
Description
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.
Time Frame
Baseline, Week 26
Title
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Description
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment*time.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Total Cholesterol
Description
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Triglycerides
Description
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Description
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Waist Circumference
Description
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Time Frame
Baseline, Week 26
Title
Number of Participants With Anti-Drug Antibodies
Description
Number of Participants With Anti-Drug Antibodies.
Time Frame
Baseline through Week 30
Title
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Description
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Time Frame
Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Internal Medicine Center LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Anaheim Clinical Trails
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Valley Clinical Trails, Inc
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Artemis Institute For Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Artemis Institute For Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
University Clinical Investigators INC
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Chase Medical Research
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
East Coast Institute For Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Suncoast Research Group, LCC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Sensible Healthcare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Palm Harbor Medical Associate
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Iderc P.L.C.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Cotton O'Neil Diabetes and Endocrine
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Clinical Research Professionals
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
The Corvallis Clinic P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
PMG Research Of Charleston LLC
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
PMG Research Of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Dallas Diabetes Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Consano Clinical Research
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Chrysalis Clinical Research
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
"For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician."
City
Gdynia
ZIP/Postal Code
81-553
Country
Poland
Facility Name
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
City
Gdynia
ZIP/Postal Code
81-553
Country
Poland
Facility Name
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
City
Katowice
ZIP/Postal Code
40-772
Country
Poland
Facility Name
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
City
Szczecin
ZIP/Postal Code
70-506
Country
Poland
Facility Name
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Manati Center for Clinical Research
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico. Inc
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group PSC
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Košice
ZIP/Postal Code
04012
Country
Slovakia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Malacky
ZIP/Postal Code
90101
Country
Slovakia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Púchov
ZIP/Postal Code
02001
Country
Slovakia
Facility Name
"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
City
Trenčín
ZIP/Postal Code
91101
Country
Slovakia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
City
Trenčín
ZIP/Postal Code
91101
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
35210595
Citation
Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.
Results Reference
derived
PubMed Identifier
34608929
Citation
Pirro V, Roth KD, Lin Y, Willency JA, Milligan PL, Wilson JM, Ruotolo G, Haupt A, Newgard CB, Duffin KL. Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Jan 18;107(2):363-378. doi: 10.1210/clinem/dgab722.
Results Reference
derived
PubMed Identifier
32291277
Citation
Hartman ML, Sanyal AJ, Loomba R, Wilson JM, Nikooienejad A, Bray R, Karanikas CA, Duffin KL, Robins DA, Haupt A. Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes. Diabetes Care. 2020 Jun;43(6):1352-1355. doi: 10.2337/dc19-1892. Epub 2020 Apr 14.
Results Reference
derived
PubMed Identifier
30293770
Citation
Frias JP, Nauck MA, Van J, Kutner ME, Cui X, Benson C, Urva S, Gimeno RE, Milicevic Z, Robins D, Haupt A. Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. Lancet. 2018 Nov 17;392(10160):2180-2193. doi: 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/diabetes/GPGB#?postal=
Description
A Study of tirzepatide in Participants With Type 2 Diabetes Mellitus

Learn more about this trial

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

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