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

July 31, 2019 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-546
        • 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.
      • Gdynia, Poland, 81-553
        • "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."
      • Gdynia, Poland, 81-553
        • 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.
      • Katowice, Poland, 40-772
        • 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.
      • Szczecin, Poland, 70-506
        • 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.
      • Łódź, Poland, 90-242
        • Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Manati Center for Clinical Research
      • San Juan, Puerto Rico, 00909
        • GCM Medical Group PSC
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico. Inc
  • Slovakia
      • Košice, Slovakia, 04012
        • 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.
      • Malacky, Slovakia, 90101
        • 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.
      • Púchov, Slovakia, 02001
        • 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.
      • Trenčín, Slovakia, 91101
        • "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."
      • Trenčín, Slovakia, 91101
        • 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.
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Internal Medicine Center LLC
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trails
      • Fresno, California, United States, 93720
        • Valley Research
      • Huntington Park, California, United States, 90255
        • National Research Institute
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Montclair, California, United States, 91763
        • Catalina Research Institute
      • Northridge, California, United States, 91325
        • Valley Clinical Trails, Inc
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • San Marcos, California, United States, 92078
        • Artemis Institute for Clinical Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tustin, California, United States, 92780
        • University Clinical Investigators INC
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research
      • Miami, Florida, United States, 33175
        • New Horizon Research Center
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LCC
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare
      • Palm Harbor, Florida, United States, 34684
        • Palm Harbor Medical Associate
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iderc P.L.C.
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes and Endocrine
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Clinical Research Professionals
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Premier Research
    • New York
      • New York, New York, United States, 10016
        • Manhattan Medical Research
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research LLC
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Aventiv Research
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic P.C.
    • South Carolina
      • Moncks Corner, South Carolina, United States, 29461
        • PMG Research of Charleston LLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research & Development
      • Knoxville, Tennessee, United States, 37938
        • PMG Research of Knoxville
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Endocrine Center
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research
    • Utah
      • Saint George, Utah, United States, 84790
        • Chrysalis Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
Drug: Placebo
Administered SC
Experimental: 1 mg Tirzepatide
1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Drug: Placebo
Administered SC
Drug: tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: 5 mg Tirzepatide
5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Drug: Placebo
Administered SC
Drug: tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Drug: Placebo
Administered SC
Drug: tirzepatide
Administered SC
Other Names:
  • LY3298176
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
Drug: Placebo
Administered SC
Drug: tirzepatide
Administered SC
Other Names:
  • LY3298176
Active Comparator: 1.5 mg Dulaglutide
1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
Drug: Placebo
Administered SC
Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
Time Frame: Baseline, Week 26

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.
Baseline, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
Time Frame: Baseline, Week 12

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.
Baseline, Week 12
Change From Baseline to Week 26 in HbA1c
Time Frame: Baseline, Week 26
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.
Baseline, Week 26
Change From Baseline to Week 12 in HbA1c
Time Frame: Baseline, Week 12
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.
Baseline, Week 12
Change From Baseline in Body Weight
Time Frame: Baseline, Week 26
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.
Baseline, Week 26
Percentage of Participants With 5% or Greater Body Weight Loss From Baseline
Time Frame: Week 26
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.
Week 26
Percentage of Participants With 10% or Greater Body Weight Loss From Baseline
Time Frame: Week 26
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.
Week 26
Percentage of Participants Reaching the HbA1c Target of ≤6.5%
Time Frame: Week 26
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.
Week 26
Percentage of Participants Reaching the HbA1c Target of <7.0%
Time Frame: Week 26
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.
Week 26
Change From Baseline in Fasting Blood Glucose
Time Frame: Baseline, Week 26
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.
Baseline, Week 26
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline, Week 26
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment*time.
Baseline, Week 26
Change From Baseline in Total Cholesterol
Time Frame: Baseline, Week 26
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Baseline, Week 26
Change From Baseline in Triglycerides
Time Frame: Baseline, Week 26
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Baseline, Week 26
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline, Week 26
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Baseline, Week 26
Change From Baseline in Waist Circumference
Time Frame: Baseline, Week 26
LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.
Baseline, Week 26
Number of Participants With Anti-Drug Antibodies
Time Frame: Baseline through Week 30
Number of Participants With Anti-Drug Antibodies.
Baseline through Week 30
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
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16335
  • I8F-MC-GPGB (Other Identifier: Eli Lilly and Company)
  • 2016-004179-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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