A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus
3 other identifiers
interventional
318
4 countries
49
Brief Summary
The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started May 2017
49 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
April 24, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedStudy Start
First participant enrolled
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
August 20, 2019
CompletedAugust 20, 2019
April 1, 2019
1.2 years
April 24, 2017
July 31, 2019
July 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 26
Secondary Outcomes (16)
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
Baseline, Week 12
Change From Baseline to Week 26 in HbA1c
Baseline, Week 26
Change From Baseline to Week 12 in HbA1c
Baseline, Week 12
Change From Baseline in Body Weight
Baseline, Week 26
Percentage of Participants With 5% or Greater Body Weight Loss From Baseline
Week 26
- +11 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORTirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
1 mg Tirzepatide
EXPERIMENTAL1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
5 mg Tirzepatide
EXPERIMENTAL5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
10 mg Tirzepatide
EXPERIMENTAL10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
15 mg Tirzepatide
EXPERIMENTAL15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
1.5 mg Dulaglutide
ACTIVE COMPARATOR1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.
Interventions
Administered SC
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
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.
- 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 (49)
Internal Medicine Center LLC
Mobile, Alabama, 36608, United States
Anaheim Clinical Trails
Anaheim, California, 92801, United States
Valley Research
Fresno, California, 93720, United States
National Research Institute
Huntington Park, California, 90255, United States
National Research Institute
Los Angeles, California, 90057, United States
Catalina Research Institute
Montclair, California, 91763, United States
Valley Clinical Trails, Inc
Northridge, California, 91325, United States
Artemis Institute For Clinical Research
San Diego, California, 92103, United States
Artemis Institute For Clinical Research
San Marcos, California, 92078, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
University Clinical Investigators INC
Tustin, California, 92780, United States
Chase Medical Research
Waterbury, Connecticut, 06708, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
East Coast Institute For Research
Jacksonville, Florida, 32216, United States
Suncoast Research Group, LCC
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Palm Harbor Medical Associate
Palm Harbor, Florida, 34684, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Iderc P.L.C.
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Diabetes and Endocrine
Topeka, Kansas, 66606, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Clinical Research Professionals
St Louis, Missouri, 63141, United States
Palm Research Center
Las Vegas, Nevada, 89128, United States
Premier Research
Trenton, New Jersey, 08611, United States
Manhattan Medical Research
New York, New York, 10016, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
Aventiv Research
Columbus, Ohio, 43213, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
PMG Research Of Charleston LLC
Moncks Corner, South Carolina, 29461, United States
New Phase Research & Development
Knoxville, Tennessee, 37909, United States
PMG Research Of Knoxville
Knoxville, Tennessee, 37938, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
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.
Gdansk, 80-546, Poland
"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, 81-553, Poland
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, 81-553, Poland
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, 40-772, Poland
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA
Lodz, 90-242, Poland
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, 70-506, Poland
Manati Center for Clinical Research
Manatí, PR, 00674, Puerto Rico
Clinical Research Puerto Rico. Inc
San Juan, 00909, Puerto Rico
GCM Medical Group PSC
San Juan, 00909, Puerto Rico
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.
Košice, 04012, Slovakia
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, 90101, Slovakia
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, 02001, Slovakia
"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, 91101, Slovakia
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.
Trenčín, 91101, Slovakia
Related Publications (4)
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.
PMID: 35210595DERIVEDPirro 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.
PMID: 34608929DERIVEDHartman 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.
PMID: 32291277DERIVEDFrias 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.
PMID: 30293770DERIVED
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
April 24, 2017
First Posted
April 27, 2017
Study Start
May 24, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 20, 2019
Results First Posted
August 20, 2019
Record last verified: 2019-04
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.