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SURPASS J-mono

CompletedPhase 3Results posted

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

A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

636

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≥23

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 IDNCT03861052

Org study ID17077

Secondary IDI8F-JE-GPGOEli Lilly and Company

Timeline

Milestones

Study first posted2019-03-04actual

Study start2019-05-07actual

Primary completion2021-03-10actual

Study completion2021-03-31actual

Last update posted2022-04-14actual

Results first posted2022-04-14actual

Assets

Investigational agents

Dulaglutide Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Participant must:

•Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.

•Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline:

–for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline.

–for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline.

•Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.

•Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.

Exclusion criteria

Participant must not:

•Have type 1 diabetes mellitus.

•Have had chronic or acute pancreatitis any time prior to study entry.

•Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.

•Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.

•Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.

•Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.

•Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Endpoints (24)

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

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
5 mg Tirzepatide	-5.8	—
10 mg Tirzepatide	-8.5	—
15 mg Tirzepatide	-10.7	—
0.75 mg Dulaglutide	-0.5	—

Least Squares Mean Difference-5.295% CI-6.4 – -4.1p<0.001Mixed Models Analysis

Least Squares Mean Difference-7.995% CI-9.1 – -6.8p<0.001Mixed Models Analysis

Least Squares Mean Difference-10.195% CI-11.3 – -9.0p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	60.76	—
10 mg Tirzepatide	82.05	—
15 mg Tirzepatide	89.31	—
0.75 mg Dulaglutide	10.69	—

Odds Ratio (OR)14.4495% CI7.88 – 26.46p<0.001Regression, Logistic

Odds Ratio (OR)44.9695% CI23.12 – 87.45p<0.001Regression, Logistic

Odds Ratio (OR)82.6795% CI39.84 – 171.52p<0.001Regression, Logistic

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Loss ≥5% From Baseline

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

16 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
5 mg Tirzepatide	-2.37	—
10 mg Tirzepatide	-2.55	—
15 mg Tirzepatide	-2.82	—
0.75 mg Dulaglutide	-1.29	—

Least Squares Mean Difference-1.0995% CI-1.27 – -0.90p<0.001Mixed Models Analysis

Least Squares Mean Difference-1.2795% CI-1.45 – -1.08p<0.001Mixed Models Analysis

Least Squares Mean Difference-1.5395% CI-1.71 – -1.35p<0.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants With HbA1c of <7.0%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	93.67	—
10 mg Tirzepatide	96.79	—
15 mg Tirzepatide	99.37	—
0.75 mg Dulaglutide	67.30	—

Odds Ratio (OR)9.8995% CI4.53 – 21.55p<0.001Regression, Logistic

Odds Ratio (OR)20.5795% CI7.73 – 54.71p<0.001Regression, Logistic

Odds Ratio (OR)85.3195% CI15.80 – 460.58p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per decilitre (mg/dL)	95% CI
5 mg Tirzepatide	-57.9	—
10 mg Tirzepatide	-64.6	—
15 mg Tirzepatide	-67.6	—
0.75 mg Dulaglutide	-31.9	—

Least Squares Mean Difference-25.995% CI-30.7 – -21.1p<0.001Mixed Models Analysis

Least Squares Mean Difference-32.795% CI-37.5 – -27.8p<0.001Mixed Models Analysis

Least Squares Mean Difference-35.795% CI-40.6 – 30.9p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
5 mg Tirzepatide	-59.5	—
10 mg Tirzepatide	-64.2	—
15 mg Tirzepatide	-68.6	—
0.75 mg Dulaglutide	-42.2	—

Least Squares Mean Difference-17.395% CI-21.4 – -13.2p<0.001ANCOVA

Least Squares Mean Difference-22.095% CI-26.1 – -17.9p<0.001ANCOVA

Least Squares Mean Difference-26.495% CI-30.5 – -22.2p<0.001ANCOVA

Secondary/registry result

Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milliunits per litre (mU/L)	95% CI
5 mg Tirzepatide	-1.07	—
10 mg Tirzepatide	-1.87	—
15 mg Tirzepatide	-2.00	—
0.75 mg Dulaglutide	1.40	—

Least Squares Mean Difference-2.4795% CI-3.67 – -1.28p<0.001Mixed Models Analysis

Least Squares Mean Difference-3.2795% CI-4.43 – -2.11p<0.001Mixed Models Analysis

Least Squares Mean Difference-3.4095% CI-4.55 – -2.25p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Fasting C-Peptide

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), micrograms per liter (ug/L)	95% CI
5 mg Tirzepatide	-0.25	—
10 mg Tirzepatide	-0.39	—
15 mg Tirzepatide	-0.37	—
0.75 mg Dulaglutide	0.01	—

Least Squares Mean Difference-0.2695% CI-0.40 – -0.13p<0.001Mixed Models Analysis

Least Squares Mean Difference-0.4095% CI-0.53 – -0.27p<0.001Mixed Models Analysis

Least Squares Mean Difference-0.3895% CI-0.51 – -0.25p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of insulin sensitivity	95% CI
5 mg Tirzepatide	38.5	—
10 mg Tirzepatide	43.0	—
15 mg Tirzepatide	46.3	—
0.75 mg Dulaglutide	22.4	—

Least Squares Mean Difference16.195% CI10.7 – 21.4p<0.001Mixed Models Analysis

Least Squares Mean Difference20.695% CI14.9 – 26.3p<0.001Mixed Models Analysis

Least Squares Mean Difference23.995% CI18.1 – 29.7p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in HOMA-2S (Insluin)

Time frame:Baseline, Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of insulin sensitivity	95% CI
5 mg Tirzepatide	14.5	—
10 mg Tirzepatide	21.6	—
15 mg Tirzepatide	25.7	—
0.75 mg Dulaglutide	-5.4	—

Least Squares Mean Difference19.995% CI11.7 – 28.2p<0.001Mixed Models Analysis

Least Squares Mean Difference27.095% CI18.0 – 36.0p<0.001Mixed Models Analysis

Least Squares Mean Difference31.295% CI22.0 – 40.4p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants With HbA1c of <7.0%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Values

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting C-Peptide

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in HOMA-2S (Insluin)

Time frame:Baseline, Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia

Time frame:Baseline through Week 52

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), Episodes/participant/365.25 days	95% CI
5 mg Tirzepatide	0	—
10 mg Tirzepatide	0	—
15 mg Tirzepatide	0.012	—
0.75 mg Dulaglutide	0	—

Secondary/registry result

Number of Participants With Anti-Tirzepatide Antibodies

Time frame:Baseline through Week 52

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (number), participants	95% CI
5 mg Tirzepatide	97	—
10 mg Tirzepatide	102	—
15 mg Tirzepatide	123	—
0.75 mg Dulaglutide	8	—

Secondary/protocol endpoint

Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe Hypoglycemia

Time frame:Baseline through Week 52

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint

Number of Participants With Anti-Tirzepatide Antibodies

Time frame:Baseline through Week 52

Immunogenicity (ADA)

threshold achievement, event

Publications (6)

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

Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2025 Sep (month)PMID40711720doi:10.1007/s13300-025-01775-yvia clinicaltrials gov reference derived + pubmed nct search
Insulin Sensitivity and Beta-Cell Function Following Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J-mono Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2025 Apr (month)PMID39951042doi:10.1007/s13300-025-01704-zvia clinicaltrials gov reference derived + pubmed nct search
Metabolic Abnormalities Following Tirzepatide Monotherapy in Japanese Patients with Type 2 Diabetes: A Phase 3 SURPASS J-mono Post Hoc Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2024 Mar (month)PMID38310163doi:10.1007/s13300-024-01534-5via clinicaltrials gov reference derived + pubmed nct search
Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial.
Diabetes therapy : research, treatment and education of diabetes and related disorders2023 Dec (month)PMID37843771doi:10.1007/s13300-023-01485-3via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial.
The lancet. Diabetes & endocrinology2022 Sep (month)PMID35914543doi:10.1016/S2213-8587(22)00188-7via clinicaltrials gov reference derived + pubmed nct search
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

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.