GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

111

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-45•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 IDNCT03311724

Org study ID16860

Secondary IDI8F-MC-GPGFEli Lilly and Company

Timeline

Milestones

Study first posted2017-10-17actual

Study start2017-10-19actual

Primary completion2018-04-24actual

Study completion2018-04-24actual

Last update posted2021-05-19actual

Results first posted2021-05-19actual

Assets

Investigational agents

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 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.

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 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.

Endpoints (16)

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

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 3 Months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
Placebo	-0.5	—
4, 8 and 12mg Tirzepatide	-5.3	—
2.5, 5, 10, and 15mg Tirzepatide	-5.5	—
2.5, 7.5 and 15mg Tirzepatide	-5.7	—

Mean Difference (Final Values)-4.895% CI-7.1 – -2.6p<0.001Mixed Models Analysis

Mean Difference (Final Values)-5.095% CI-7.2 – -2.7p<0.001Mixed Models Analysis

Mean Difference (Final Values)-5.295% CI-7.5 – -2.9p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, 3 Months

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centimeter (cm)	95% CI
Placebo	-2.5	—
4, 8 and 12mg Tirzepatide	-4.8	—
2.5, 5, 10, and 15mg Tirzepatide	-4.9	—
2.5, 7.5 and 15mg Tirzepatide	-4.9	—

Mean Difference (Final Values)-2.295% CI-4.7 – 0.2p0.075Mixed Models Analysis

Mean Difference (Final Values)-2.495% CI-4.9 – 0.1p0.065Mixed Models Analysis

Mean Difference (Final Values)-2.495% CI-4.9 – 0.2p0.065Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 3 Months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, 3 Months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Change From Baseline in Haemoglobin A1c (HbA1c)

Time frame:Baseline, 3 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1C	95% CI
Placebo	0.2	—
4, 8 and 12mg Tirzepatide	-1.7	—
2.5, 5, 10, and 15mg Tirzepatide	-2.0	—
2.5, 7.5 and 15mg Tirzepatide	-1.8	—

Mean Difference (Final Values)-1.995% CI-2.5 – -1.4p<0.001Mixed Models Analysis

Mean Difference (Final Values)-2.295% CI-2.8 – -1.7p<0.001Mixed Models Analysis

Mean Difference (Final Values)-2.095% CI-2.5 – -1.4p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Haemoglobin A1c (HbA1c)

Time frame:Baseline, 3 Months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Achieving HbA1c Target of <7.0%

Time frame:3 Months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	10	—
4, 8 and 12mg Tirzepatide	74.1	—
2.5, 5, 10, and 15mg Tirzepatide	87	—
2.5, 7.5 and 15mg Tirzepatide	84.6	—

Odds Ratio (OR)56.5495% CI9.43 – 338.97p<0.001Regression, Logistic

Odds Ratio (OR)183.4895% CI22.0 – 999p<0.001Regression, Logistic

Odds Ratio (OR)157.5495% CI21.63 – 999p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, 3 Months

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	-12.3	—
4, 8 and 12mg Tirzepatide	-60.7	—
2.5, 5, 10, and 15mg Tirzepatide	-70.2	—
2.5, 7.5 and 15mg Tirzepatide	-74.2	—

Mean Difference (Final Values)-48.595% CI-70.6 – -26.3p<0.001Mixed Models Analysis

Mean Difference (Final Values)-58.095% CI-80.7 – -35.2p<0.001Mixed Models Analysis

Mean Difference (Final Values)-61.995% CI-84.6 – -39.2p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Target of <7.0%

Time frame:3 Months

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, 3 Months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Number of Participants With Anti Drug Antibodies

Time frame:Baseline through 3 Months

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (number), participants	95% CI
Placebo	0	—
4, 8 and 12mg Tirzepatide	10	—
2.5, 5, 10, and 15mg Tirzepatide	8	—
2.5, 7.5 and 15mg Tirzepatide	4	—

Secondary/registry result

Number of Episodes of Total Hypoglycemia Episodes

Time frame:Baseline through 3 Months

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Placebo	0	—
4, 8 and 12mg Tirzepatide	0	—
2.5, 5, 10, and 15mg Tirzepatide	0	—
2.5, 7.5 and 15mg Tirzepatide	1	—

Secondary/registry result

Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide

Time frame:Week 4, 8 12: Pre-dose

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (mean), nanograms per milliliter (ng/mL)	95% CI
4, 8 and 12mg Tirzepatide	508	—
2.5, 5, 10, and 15mg Tirzepatide	704	—
2.5, 7.5 and 15mg Tirzepatide	630	—

Secondary/protocol endpoint

Number of Participants With Anti Drug Antibodies

Time frame:Baseline through 3 Months

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Number of Episodes of Total Hypoglycemia Episodes

Time frame:Baseline through 3 Months

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide

Time frame:Week 4, 8 12: Pre-dose

Plasma concentration (steady state)

concentration, descriptive

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.