Type 2 DiabetesPhase 2NCT03311724

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

A Phase 2 study testing Tirzepatide in people with Type 2 Diabetes, run by Eli Lilly and Company at 13 sites in United States.

Completed

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

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Tirzepatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 13 sitesUnited States
Study dates: 19 Oct 2017to 24 Apr 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 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.

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 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.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Aventiv Research
Columbus, Ohio, 43213
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Valley Research
Fresno, California, 93720
New Phase Research & Development
Knoxville, Tennessee, 37909
National Research Institute
Los Angeles, California, 90057
Solaris Clinical Research
Meridian, Idaho, 83646
Suncoast Research Group, LLC
Miami, Florida, 33135
Catalina Research Institute, LLC
Montclair, California, 91763
Consano Clinical Research
Shavano Park, Texas, 78231
Clinical Research Professionals
St Louis, Missouri, 63141
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606
University Clinical Investigators, Inc.
Tustin, California, 92780
Chase Medical Research, LLC
Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus

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

Conditions: Type 2 Diabetes
Being tested: Tirzepatide, 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
PlaceboDrug
Administered SC

Study groups in NCT03311724
Study group	Role	What they receive
4,8,12mg Tirzepatide	Experimental	Participants 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. Receives: Drug: Tirzepatide
2.5,5,10,15mg Tirzepatide	Experimental	Participants 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. Receives: Drug: Tirzepatide
2.5,7.5,15mg Tirzepatide	Experimental	Participants 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. Receives: Drug: Tirzepatide
Placebo	Placebo comparator	Placebo administered by SC injection. Receives: Drug: Placebo

What is being measured

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

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.
Measured: Baseline, 3 Months

Secondary outcomes (7)

Percentage of Participants Achieving HbA1c Target of <7.0%
Percentage of participants achieving HbA1c target of < (less than) 7.0%.
Measured: 3 Months
Change From Baseline in Fasting Blood Glucose (FBG)
LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.
Measured: Baseline, 3 Months
Change From Baseline in Body Weight
LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.
Measured: Baseline, 3 Months
Change From Baseline in Waist Circumference
LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.
Measured: Baseline, 3 Months
Number of Participants With Anti Drug Antibodies
Number of participants with anti drug antibodies.
Measured: Baseline through 3 Months
Number of Episodes of Total Hypoglycemia Episodes
Number of episodes of total hypoglycemia episodes with plasma glucose <= ( less than or equal to) 54 mg/dL.
Measured: Baseline through 3 Months
Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide
Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide.
Measured: Week 4, 8 12: Pre-dose

Timeline

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

19 Oct 201724 Apr 2018

First posted17 Oct 2017
Study start19 Oct 2017
Primary completion24 Apr 2018
Study completion24 Apr 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.
Other trials for Type 2 DiabetesStudies 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: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03311724
Sponsor's protocol ID: 16860
Other IDs: I8F-MC-GPGF
Status last verified: Apr 2021
First submitted: 12 Oct 2017
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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.

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?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT03311724
Acronym / sponsor ID: 16860
Conditions: Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 19 Oct 2017 (actual)
Primary completion: 24 Apr 2018 (actual)
Study completion: 24 Apr 2018 (actual)
First posted: 17 Oct 2017 (actual)
Results: Posted 19 May 2021

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 determine the efficacy of tirzepatide in participants with type 2 diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
4,8,12mg Tirzepatide	Experimental	Drug: TirzepatideParticipants 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	Experimental	Drug: TirzepatideParticipants 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	Experimental	Drug: TirzepatideParticipants 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 comparator	Drug: PlaceboPlacebo administered by SC injection.

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 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.

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 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.

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	2.5,5,10,15mg Tirzepatide, 2.5,7.5,15mg Tirzepatide, 4,8,12mg Tirzepatide
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Change From Baseline in Haemoglobin A1c (HbA1c)
Time frame: Baseline, 3 Months
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.

7 secondary outcomes

Percentage of Participants Achieving HbA1c Target of <7.0%
Time frame: 3 Months
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame: Baseline, 3 Months
Change From Baseline in Body Weight
Time frame: Baseline, 3 Months
Change From Baseline in Waist Circumference
Time frame: Baseline, 3 Months
Number of Participants With Anti Drug Antibodies
Time frame: Baseline through 3 Months
Number of Episodes of Total Hypoglycemia Episodes
Time frame: Baseline through 3 Months
Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide
Time frame: Week 4, 8 12: Pre-dose

Results and safety

Results posted to the registry on 19 May 2021, 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	26	23
4, 8 and 12mg Tirzepatide	29	28
2.5, 5, 10, and 15mg Tirzepatide	28	26
2.5, 7.5 and 15mg Tirzepatide	28	27

Primary outcome: Change From Baseline in Haemoglobin A1c (HbA1c)

Time frame: Baseline, 3 Months. Least squares mean (Standard Error). Unit: Percentage of HbA1C

Measure	Placebo n = 20	4, 8 and 12mg Tirzepatide n = 27	2.5, 5, 10, and 15mg Tirzepatide n = 23	2.5, 7.5 and 15mg Tirzepatide n = 26
Value	0.2 (0.21)	-1.7 (0.19)	-2.0 (0.20)	-1.8 (0.19)

Placebo vs 4, 8 and 12mg Tirzepatide: Mean Difference (Final Values): -1.9 (95% CI -2.5 to -1.4), p <0.001, Mixed Models Analysis
Placebo vs 2.5, 5, 10, and 15mg Tirzepatide: Mean Difference (Final Values): -2.2 (95% CI -2.8 to -1.7), p <0.001, Mixed Models Analysis
Placebo vs 2.5, 7.5 and 15mg Tirzepatide: Mean Difference (Final Values): -2.0 (95% CI -2.5 to -1.4), p <0.001, Mixed Models Analysis

Population analysed: All participants who received at least 1 dose of study drug and had baseline and at least one post baseline data. Participants who discontinued study drug or initiated rescue drug were excluded.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through end of study (Up to 15 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 26 (0%)	7 of 26 (26.9%)	0 of 26
4, 8 and 12mg Tirzepatide	1 of 29 (3.4%)	19 of 29 (65.5%)	0 of 29
2.5, 5, 10, and 15mg Tirzepatide	0 of 28 (0%)	18 of 28 (64.3%)	0 of 28
2.5, 7.5 and 15mg Tirzepatide	0 of 28 (0%)	22 of 28 (78.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of Tirzepatide in Participants With Type 2 DiabetesLink 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

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Type 2 Diabetes, run by Eli Lilly and Company at 13 sites in United States.

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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 19 May 2021). 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 in Haemoglobin A1c (HbA1c) (time frame: Baseline, 3 Months). 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 NCT03311724.

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 19 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.