Type 2 Diabetes MellitusPhase 2NCT03131687

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

A Phase 2 study testing tirzepatide and Dulaglutide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 49 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: tirzepatide and Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 318 participants
Where: 49 sitesin 4 countries
Study dates: 24 May 2017to 1 Aug 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

49 sites in 4 countries.

Country

City, postcode or hospital

49 sites in 4 countries

United States35 sites

Anaheim Clinical Trails
Anaheim, California, 92801
Aventiv Research
Columbus, Ohio, 43213
Clinical Research of South Florida
Coral Gables, Florida, 33134
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Lillestol Research LLC
Fargo, North Dakota, 58103
Valley Research
Fresno, California, 93720
National Research Institute
Huntington Park, California, 90255
East Coast Institute For Research
Jacksonville, Florida, 32216
New Phase Research & Development
Knoxville, Tennessee, 37909
PMG Research Of Knoxville
Knoxville, Tennessee, 37938
Palm Research Center
Las Vegas, Nevada, 89128
National Research Institute
Los Angeles, California, 90057
Solaris Clinical Research
Meridian, Idaho, 83646
ActivMed Practices & Research
Methuen, Massachusetts, 01844
Suncoast Research Group, LCC
Miami, Florida, 33135
New Horizon Research Center
Miami, Florida, 33175
Internal Medicine Center LLC
Mobile, Alabama, 36608
PMG Research Of Charleston LLC
Moncks Corner, South Carolina, 29461
Catalina Research Institute
Montclair, California, 91763
Manhattan Medical Research
New York, New York, 10016
Valley Clinical Trails, Inc
Northridge, California, 91325
Sensible Healthcare
Ocoee, Florida, 34761
Palm Harbor Medical Associate
Palm Harbor, Florida, 34684
Artemis Institute For Clinical Research
San Diego, California, 92103
Artemis Institute For Clinical Research
San Marcos, California, 92078
Consano Clinical Research
Shavano Park, Texas, 78231
Encompass Clinical Research
Spring Valley, California, 91978
Clinical Research Professionals
St Louis, Missouri, 63141
Chrysalis Clinical Research
St. George, Utah, 84790
Cotton O'Neil Diabetes and Endocrine
Topeka, Kansas, 66606
Premier Research
Trenton, New Jersey, 08611
University Clinical Investigators INC
Tustin, California, 92780
Chase Medical Research
Waterbury, Connecticut, 06708
Iderc P.L.C.
West Des Moines, Iowa, 50265

Other trials in United States

Poland6 sites

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
"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
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
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
Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA
Lodz, 90-242
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

Other trials in Poland

Slovakia5 sites

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
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
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
"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
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

Other trials in Slovakia

Puerto Rico3 sites

Manati Center for Clinical Research
Manati, PR, 00674
Clinical Research Puerto Rico. Inc
San Juan, 00909
GCM Medical Group PSC
San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions: Type 2 Diabetes Mellitus
Being tested: tirzepatide, Dulaglutide, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tirzepatideDrug
Also called LY3298176
Administered SC
DulaglutideDrug
Also called LY2189265
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT03131687
Study group	Role	What they receive
Placebo	Placebo comparator	Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly. Receives: Drug: Placebo
1 mg Tirzepatide	Experimental	1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly. Receives: Drug: tirzepatide; Drug: Placebo
5 mg Tirzepatide	Experimental	5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly. Receives: Drug: tirzepatide; Drug: Placebo
10 mg Tirzepatide	Experimental	10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly. Receives: Drug: tirzepatide; Drug: Placebo
15 mg Tirzepatide	Experimental	15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly. Receives: Drug: tirzepatide; Drug: Placebo
1.5 mg Dulaglutide	Active comparator	1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly. Receives: Drug: Dulaglutide; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 26

Secondary outcomes (16)

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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 26
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.
Measured: Week 26
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.
Measured: Week 26
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.
Measured: Week 26
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.
Measured: Week 26
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 26
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.
Measured: Baseline, Week 26
Number of Participants With Anti-Drug Antibodies
Number of Participants With Anti-Drug Antibodies.
Measured: Baseline through Week 30
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide
Measured: Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 20171 Aug 2018

First posted27 Apr 2017
Study start24 May 2017
Primary completion1 Aug 2018
Study completion1 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03131687
Sponsor's protocol ID: 16335
Other IDs: I8F-MC-GPGB, 2016-004179-33, 2016
Status last verified: Apr 2019
First submitted: 24 Apr 2017
Last updated: 20 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 35210595
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.
PubMed 34608929
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.
PubMed 32291277
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.
PubMed 30293770

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03131687
Acronym / sponsor ID: 16335
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 24 May 2017 (actual)
Primary completion: 1 Aug 2018 (actual)
Study completion: 1 Aug 2018 (actual)
First posted: 27 Apr 2017 (actual)
Results: Posted 20 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboTirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.
1 mg Tirzepatide	Experimental	Drug: tirzepatide, Drug: Placebo1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
5 mg Tirzepatide	Experimental	Drug: tirzepatide, Drug: Placebo5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
10 mg Tirzepatide	Experimental	Drug: tirzepatide, Drug: Placebo10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
15 mg Tirzepatide	Experimental	Drug: tirzepatide, Drug: Placebo15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.
1.5 mg Dulaglutide	Active comparator	Drug: Dulaglutide, Drug: Placebo1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tirzepatideAlso: LY3298176Administered SC	Drug	1 mg Tirzepatide, 10 mg Tirzepatide, 15 mg Tirzepatide, 5 mg Tirzepatide
DulaglutideAlso: LY2189265Administered SC	Drug	1.5 mg Dulaglutide
PlaceboAdministered SC	Drug	1 mg Tirzepatide, 1.5 mg Dulaglutide, 10 mg Tirzepatide, 15 mg Tirzepatide, 5 mg Tirzepatide, Placebo

Primary outcome

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.

16 secondary outcomes

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response
Time frame: Baseline, Week 12
Change From Baseline to Week 26 in HbA1c
Time frame: Baseline, Week 26
Change From Baseline to Week 12 in HbA1c
Time frame: Baseline, Week 12
Change From Baseline in Body Weight
Time frame: Baseline, Week 26
Percentage of Participants With 5% or Greater Body Weight Loss From Baseline
Time frame: Week 26
Percentage of Participants With 10% or Greater Body Weight Loss From Baseline
Time frame: Week 26
Percentage of Participants Reaching the HbA1c Target of ≤6.5%
Time frame: Week 26
Percentage of Participants Reaching the HbA1c Target of <7.0%
Time frame: Week 26
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 26
Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, Week 26
Change From Baseline in Total Cholesterol
Time frame: Baseline, Week 26
Change From Baseline in Triglycerides
Time frame: Baseline, Week 26
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Week 26
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 26
Number of Participants With Anti-Drug Antibodies
Time frame: 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

Results and safety

Results posted to the registry on 20 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	51	45
1 mg Tirzepatide	53	44
5 mg Tirzepatide	55	52
10 mg Tirzepatide	52	48
15 mg Tirzepatide	53	45
1.5 mg Dulaglutide	54	49

Primary outcome: Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

Time frame: Baseline, Week 26. Least squares mean (Standard Deviation). Unit: Percentage of HbA1c

Measure	Placebo n = 44	1 mg Tirzepatide n = 45	5 mg Tirzepatide n = 52	10 mg Tirzepatide n = 47	15 mg Tirzepatide n = 44	1.5 mg Dulaglutide n = 49
Value	-0.06 (0.14)	-1.06 (0.11)	-1.73 (0.08)	-1.89 (0.08)	-1.94 (0.09)	-1.21 (0.14)

Placebo vs 1 mg Tirzepatide: Posterior Mean Difference: -1.00
Placebo vs 5 mg Tirzepatide: Posterior Mean Difference: -1.67
Placebo vs 10 mg Tirzepatide: Posterior Mean Difference: -1.83

Population analysed: All randomized participants who received at least one dose of study drug and had a baseline and postbaseline excluding data after rescue drug initiation.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 34 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 51 (3.9%)	17 of 51 (33.3%)	0 of 51
1 mg Tirzepatide	2 of 52 (3.8%)	17 of 52 (32.7%)	1 of 52
5 mg Tirzepatide	1 of 55 (1.8%)	29 of 55 (52.7%)	0 of 55
10 mg Tirzepatide	3 of 51 (5.9%)	32 of 51 (62.7%)	0 of 51
15 mg Tirzepatide + Placebo	2 of 53 (3.8%)	39 of 53 (73.6%)	0 of 53
1.5 mg Dulaglutide	3 of 54 (5.6%)	31 of 54 (57.4%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35210595Sattar 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.
Derived from this study: PubMed 34608929Pirro 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.
Derived from this study: PubMed 32291277Hartman 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.
Derived from this study: PubMed 30293770Frias 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.
A Study of tirzepatide in Participants With Type 2 Diabetes MellitusLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

49 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tirzepatide and Dulaglutide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 49 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Poland, Slovakia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03131687, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.