A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
111
1 country
13
Brief Summary
The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Oct 2017
Shorter than P25 for phase_2 type-2-diabetes
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2018
CompletedResults Posted
Study results publicly available
May 19, 2021
CompletedMay 19, 2021
April 1, 2021
6 months
October 12, 2017
April 28, 2021
April 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Haemoglobin A1c (HbA1c)
Least squares (LS) mean was calculated using mixed model repeated measures model (MMRM) with baseline + baseline BMI group + baseline metformin flag + treatment + time + treatment\*time as fixed factors.
Baseline, 3 Months
Secondary Outcomes (7)
Percentage of Participants Achieving HbA1c Target of <7.0%
3 Months
Change From Baseline in Fasting Blood Glucose (FBG)
Baseline, 3 Months
Change From Baseline in Body Weight
Baseline, 3 Months
Change From Baseline in Waist Circumference
Baseline, 3 Months
Number of Participants With Anti Drug Antibodies
Baseline through 3 Months
- +2 more secondary outcomes
Study Arms (4)
4,8,12mg Tirzepatide
EXPERIMENTALParticipants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
2.5,5,10,15mg Tirzepatide
EXPERIMENTALParticipants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
2.5,7.5,15mg Tirzepatide
EXPERIMENTALParticipants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
Placebo
PLACEBO COMPARATORPlacebo administered by SC injection.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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 (Inclusive) kilograms per square meter.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Valley Research
Fresno, California, 93720, United States
National Research Institute
Los Angeles, California, 90057, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606, United States
Clinical Research Professionals
St Louis, Missouri, 63141, United States
Aventiv Research
Columbus, Ohio, 43213, United States
New Phase Research & Development
Knoxville, Tennessee, 37909, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 17, 2017
Study Start
October 19, 2017
Primary Completion
April 24, 2018
Study Completion
April 24, 2018
Last Updated
May 19, 2021
Results First Posted
May 19, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.