GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

318

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-50•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03131687

Org study ID16335

Secondary ID2016-004179-33

Secondary IDI8F-MC-GPGBEli Lilly and Company

Timeline

Milestones

Study first posted2017-04-27actual

Study start2017-05-24actual

Primary completion2018-08-01actual

Study completion2018-08-01actual

Last update posted2019-08-20actual

Results first posted2019-08-20actual

Assets

Investigational agents

Dulaglutide Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

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.

•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.

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

8 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms (Kg)	95% CI
Placebo	-0.4	—
1 mg Tirzepatide	-0.9	—
5 mg Tirzepatide	-4.8	—
10 mg Tirzepatide	-8.7	—
15 mg Tirzepatide	-11.3	—
1.5 mg Dulaglutide	-2.7	—

Mean Difference (Final Values)-0.595% CI-2.7 – 1.7p0.655Mixed Models Analysis

Mean Difference (Final Values)-4.495% CI-6.6 – -2.3p<0.001Mixed Models Analysis

Mean Difference (Final Values)-8.395% CI-10.5 – -6.0p<0.001Mixed Models Analysis

Median Difference (Final Values)-10.995% CI-13.3 – -8.6p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants With 5% or Greater Body Weight Loss From Baseline

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	0	—
1 mg Tirzepatide	13.5	—
5 mg Tirzepatide	47.3	—
10 mg Tirzepatide	70.6	—
15 mg Tirzepatide	62.3	—
1.5 mg Dulaglutide	22.2	—

p0.053Regression, Logistic

p0.002Regression, Logistic

p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants With 10% or Greater Body Weight Loss From Baseline

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	0	—
1 mg Tirzepatide	5.8	—
5 mg Tirzepatide	16.4	—
10 mg Tirzepatide	39.2	—
15 mg Tirzepatide	37.7	—
1.5 mg Dulaglutide	9.3	—

p0.193Regression, Logistic

p0.036Regression, Logistic

p0.003Regression, Logistic

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centimeters (cm)	95% CI
Placebo	-1.3	—
1 mg Tirzepatide	-2.1	—
5 mg Tirzepatide	-5.1	—
10 mg Tirzepatide	-7.4	—
15 mg Tirzepatide	-10.2	—
1.5 mg Dulaglutide	-2.5	—

Mean Difference (Final Values)-0.795% CI-3.1 – 1.6p0.539Mixed Models Analysis

Mean Difference (Final Values)-3.895% CI-6.1 – -1.5p0.001Mixed Models Analysis

Mean Difference (Final Values)-6.095% CI-8.4 – -3.7p<0.001Mixed Models Analysis

Mean Difference (Final Values)-8.895% CI-11.3 – -6.4p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With 5% or Greater Body Weight Loss From Baseline

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With 10% or Greater Body Weight Loss From Baseline

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 26

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

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

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Placebo	-0.06	—
1 mg Tirzepatide	-1.06	—
5 mg Tirzepatide	-1.73	—
10 mg Tirzepatide	-1.89	—
15 mg Tirzepatide	-1.94	—
1.5 mg Dulaglutide	-1.21	—

Posterior Mean Difference-1.00

Posterior Mean Difference-1.67

Posterior Mean Difference-1.83

Posterior Mean Difference-1.89

Primary/protocol endpoint

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

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Placebo	-0.05	—
1 mg Tirzepatide	-0.94	—
5 mg Tirzepatide	-1.54	—
10 mg Tirzepatide	-1.68	—
15 mg Tirzepatide	-1.72	—
1.5 mg Dulaglutide	-1.08	—

Posterior Mean Difference-0.89

Posterior Mean Difference-1.49

Posterior Mean Difference-1.62

Posterior Mean Difference-1.67

Secondary/registry result

Change From Baseline to Week 26 in HbA1c

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Placebo	0.1	—
1 mg Tirzepatide	-0.7	—
5 mg Tirzepatide	-1.6	—
10 mg Tirzepatide	-2.0	—
15 mg Tirzepatide	-2.4	—
1.5 mg Dulaglutide	-1.1	—

Mean Difference (Final Values)-0.895% CI-1.2 – -0.4p<0.001Mixed Models Analysis

Median Difference (Final Values)-1.795% CI-2.2 – -1.3p<0.001Mixed Models Analysis

Median Difference (Final Values)-2.195% CI-2.5 – -1.6p<0.001Mixed Models Analysis

Median Difference (Final Values)-2.595% CI-2.9 – -2.0p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline to Week 12 in HbA1c

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Placebo	-0.1	—
1 mg Tirzepatide	-0.9	—
5 mg Tirzepatide	-1.7	—
10 mg Tirzepatide	-2.0	—
15 mg Tirzepatide	-2.1	—
1.5 mg Dulaglutide	-1.2	—

Mean Difference (Final Values)-0.895% CI-1.1 – -0.4p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.795% CI-2.0 – -1.3p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.995% CI-2.3 – -1.5p<0.001Mixed Models Analysis

Mean Difference (Final Values)-2.195% CI-2.4 – -1.7p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Reaching the HbA1c Target of ≤6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	2.0	—
1 mg Tirzepatide	15.4	—
5 mg Tirzepatide	63.6	—
10 mg Tirzepatide	82.0	—
15 mg Tirzepatide	58.5	—
1.5 mg Dulaglutide	38.9	—

p0.030Regression, Logistic

p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Reaching the HbA1c Target of <7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	11.8	—
1 mg Tirzepatide	32.7	—
5 mg Tirzepatide	69.1	—
10 mg Tirzepatide	90.0	—
15 mg Tirzepatide	77.4	—
1.5 mg Dulaglutide	51.9	—

p0.008Regression, Logistic

p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
Placebo	15.5	—
1 mg Tirzepatide	-6.8	—
5 mg Tirzepatide	-40.7	—
10 mg Tirzepatide	-60.7	—
15 mg Tirzepatide	-57.5	—
1.5 mg Dulaglutide	-21.2	—

Mean Difference (Final Values)-22.495% CI-39.4 – -5.3p0.010Mixed Models Analysis

Mean Difference (Final Values)-56.295% CI-72.9 – -39.5p<0.001Mixed Models Analysis

Odds Ratio (OR)-76.395% CI-93.3 – -59.2p<0.001Mixed Models Analysis

Mean Difference (Final Values)-73.095% CI-90.9 – -55.2p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to Week 26 in HbA1c

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to Week 12 in HbA1c

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching the HbA1c Target of ≤6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching the HbA1c Target of <7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), Millimoles Per Litre (mmol/L)	95% CI
Placebo	0.0	—
1 mg Tirzepatide	-0.0	—
5 mg Tirzepatide	0.0	—
10 mg Tirzepatide	0.0	—
15 mg Tirzepatide	0.1	—
1.5 mg Dulaglutide	0.0	—

Mean Difference (Final Values)-0.095% CI-0.1 – 0.0p0.396Mixed Models Analysis

Mean Difference (Final Values)-0.095% CI-0.1 – 0.1p0.903Mixed Models Analysis

Mean Difference (Final Values)0.095% CI-0.1 – 0.1p0.536Mixed Models Analysis

Mean Difference (Final Values)0.095% CI-0.0 – 0.1p0.325Mixed Models Analysis

Secondary/registry result

Change From Baseline in Total Cholesterol

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), Millimoles Per Litre (mmol/L)	95% CI
Placebo	0.3	—
1 mg Tirzepatide	0.2	—
5 mg Tirzepatide	-0.1	—
10 mg Tirzepatide	-0.3	—
15 mg Tirzepatide	-0.3	—
1.5 mg Dulaglutide	-0.2	—

Mean Difference (Final Values)-0.195% CI-0.4 – 0.2p0.565Mixed Models Analysis

Mean Difference (Final Values)-0.495% CI-0.7 – -0.1p0.010Mixed Models Analysis

Median Difference (Final Values)-0.595% CI-0.9 – -0.2p0.001Mixed Models Analysis

Median Difference (Final Values)-0.695% CI-0.9 – -0.3p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Triglycerides

Time frame:Baseline, Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), Millimoles Per Litre (mmol/L)	95% CI
Placebo	0.3	—
1 mg Tirzepatide	-0.0	—
5 mg Tirzepatide	-0.5	—
10 mg Tirzepatide	-0.7	—
15 mg Tirzepatide	-0.8	—
1.5 mg Dulaglutide	-0.3	—

Mean Difference (Final Values)-0.395% CI-0.7 – 0.1p0.164Mixed Models Analysis

Mean Difference (Final Values)-0.895% CI-1.1 – -0.4p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.095% CI-1.4 – -0.6p<0.001Mixed Models Analysis

Median Difference (Final Values)-1.195% CI-1.5 – -0.7p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline, Week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), Millimoles Per Litre (mmol/L)	95% CI
Placebo	0.2	—
1 mg Tirzepatide	0.2	—
5 mg Tirzepatide	0.0	—
10 mg Tirzepatide	-0.0	—
15 mg Tirzepatide	-0.1	—
1.5 mg Dulaglutide	-0.1	—

Mean Difference (Final Values)0.095% CI-0.3 – 0.3p0.919Mixed Models Analysis

Mean Difference (Final Values)-0.295% CI-0.5 – 0.1p0.194Mixed Models Analysis

Mean Difference (Final Values)-0.295% CI-0.5 – 0.1p0.145Mixed Models Analysis

Mean Difference (Final Values)-0.395% CI-0.6 – 0.0p0.067Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline in Triglycerides

Time frame:Baseline, Week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline, Week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Participants With Anti-Drug Antibodies

Time frame:Baseline through Week 30

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Placebo	0	—
1 mg Tirzepatide	16	—
5 mg Tirzepatide	19	—
10 mg Tirzepatide	24	—
15 mg Tirzepatide	26	—
1.5 mg Dulaglutide	0	—

Secondary/registry result

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

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanograms Per Millilitre (ng/mL)	95% CI
1 mg Tirzepatide	78.6	—
5 mg Tirzepatide	394	—
10 mg Tirzepatide	787	—
15 mg Tirzepatide	1180	—

Secondary/protocol endpoint

Number of Participants With Anti-Drug Antibodies

Time frame:Baseline through Week 30

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

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

Plasma concentration (steady state)

concentration, descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis.
Nature medicine2022 Mar (month)PMID35210595doi:10.1038/s41591-022-01707-4via clinicaltrials gov reference derived + pubmed nct search
Effects of Tirzepatide, a Dual GIP and GLP-1 RA, on Lipid and Metabolite Profiles in Subjects With Type 2 Diabetes.
The Journal of clinical endocrinology and metabolism2022 Jan 18PMID34608929doi:10.1210/clinem/dgab722via clinicaltrials gov reference derived + pubmed nct search
Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes.
Diabetes care2020 Jun (month)PMID32291277doi:10.2337/dc19-1892via clinicaltrials gov reference derived + pubmed nct search
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 (London, England)2018 Nov 17PMID30293770doi:10.1016/S0140-6736(18)32260-8via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.