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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03311724
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 12, 2017
First Posted Date  ICMJE October 17, 2017
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE October 19, 2017
Actual Primary Completion Date April 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 3 Months ]
Change from baseline in HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • Proportion of Participants Achieving HbA1c Target of <7.0% [ Time Frame: 3 Months ]
    Proportion of participants achieving HbA1c target of <7.0%
  • Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 3 Months ]
    Change from baseline in FBG
  • Change from Baseline in Body Weight [ Time Frame: Baseline, 3 Months ]
    Change from baseline in body weight
  • Change from Baseline in Waist Circumference [ Time Frame: Baseline, 3 Months ]
    Change from baseline in waist circumference
  • Number of Participants with Anti-Tirzepatide Antibodies [ Time Frame: Baseline through 3 Months ]
    Number of participants with anti-Tirzepatide antibodies
  • Rate of Total Hypoglycemia [ Time Frame: Baseline through 3 Months ]
    Rate of total hypoglycemia
  • Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide [ Time Frame: Predose Month 1 through 3 Months ]
    PK: Conctrough of Tirzepatide
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • Proportion of Participants Achieving HbA1c Target of <7.0% [ Time Frame: 3 Months ]
    Proportion of participants achieving HbA1c target of <7.0%
  • Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 3 Months ]
    Change from baseline in FBG
  • Change from Baseline in Body Weight [ Time Frame: Baseline, 3 Months ]
    Change from baseline in body weight
  • Change from Baseline in Waist Circumference [ Time Frame: Baseline, 3 Months ]
    Change from baseline in waist circumference
  • Number of Participants with Anti-LY3298176 Antibodies [ Time Frame: Baseline through 3 Months ]
    Number of participants with anti-LY3298176 antibodies
  • Rate of Total Hypoglycemia [ Time Frame: Baseline through 3 Months ]
    Rate of total hypoglycemia
  • Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of LY3298176 [ Time Frame: Predose Month 1 through 3 Months ]
    PK: Conctrough of LY3298176
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Official Title  ICMJE A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus
Brief Summary The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Tirzepatide Group 1
    Tirzepatide administered subcutaneously (SC)
    Intervention: Drug: Tirzepatide
  • Experimental: Tirzepatide Group 2
    Tirzepatide administered SC
    Intervention: Drug: Tirzepatide
  • Experimental: Tirzepatide Group 3
    Tirzepatide administered SC
    Intervention: Drug: Tirzepatide
  • Placebo Comparator: Placebo
    Placebo administered SC
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2018)
111
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
92
Actual Study Completion Date  ICMJE April 24, 2018
Actual Primary Completion Date April 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03311724
Other Study ID Numbers  ICMJE 16860
I8F-MC-GPGF ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP