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SURPASS-SWITCH

CompletedPhase 4Results posted

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

A Phase 4, Randomized, Open-Label, Active-Controlled Study to Investigate the Efficacy and Safety of Switching From Weekly Dulaglutide to Weekly Tirzepatide in Adults With Type 2 Diabetes

Assets

Dulaglutide / Tirzepatide

Listed sites

38

Recruiting sites

Enrollment

282

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥25HbA1c ≥7%

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 IDNCT05564039
Org study ID18395
Secondary ID2022-500101-41-00EU Trial Number
Secondary IDI8F-MC-GPIHEli Lilly and Company

Timeline

Milestones

Study first posted2022-10-03actual
Study start2022-11-30actual
Primary completion2024-07-15actual
Study completion2024-08-12actual
Last update posted2025-08-03actual
Results first posted2025-08-03actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have type 2 diabetes
Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening.
No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, sodium glucose cotransporter-2 inhibitors (SGLT-2i), and/or sulfonylurea, for at least 3 months before screening.
Have had stable body weight (±5%) during the 90 days preceding screening
Have BMI ≥25 kilogram/square meter (kg/m²)

Exclusion criteria

Have type 1 diabetes
Have a history of chronic or acute pancreatitis
Have a history of
proliferative diabetic retinopathy, or
diabetic maculopathy, or
nonproliferative diabetic retinopathy that requires acute treatment.
Have any of these cardiovascular (CV) conditions within 60 days prior to screening:
acute myocardial infarction,
cerebrovascular accident (stroke), or
hospitalization due to congestive heart failure (CHF).
Have New York Heart Assocation (NYHA) Functional Classification Class IV CHF
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over-the-counter, or alternative remedies
Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label)
Have been treated with insulin prior to screening
Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.
Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation

Endpoints (26)

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

Weight & body composition
12
Glycemic / diabetes
12
Patient-reported / QoL
2

Weight & body composition

12 endpoints
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
15 mg Tirzepatide or MTD-11.0
4.5 mg Dulaglutide or MTD-3.6
LS Mean difference (Final Values)-7.495% CI-8.7-6.0p<.0001Mixed Models Analysis
Secondary/registry result

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

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD84.33
4.5 mg Dulaglutide or MTD37.40
Odds Ratio (OR)9.3195% CI5.1116.98p<0.0001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD58.21
4.5 mg Dulaglutide or MTD6.87
Odds Ratio (OR)19.3595% CI9.0741.30p<0.0001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD27.61
4.5 mg Dulaglutide or MTD0.76
Odds Ratio (OR)35.8395% CI7.18178.89p<0.0001Regression, Logistic
Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 40

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), centimeter (cm)95% CI
15 mg Tirzepatide or MTD-8.2
4.5 mg Dulaglutide or MTD-3.1
LS Mean difference (Final Values)-5.195% CI-7.8-2.5p0.0002Mixed Models Analysis
Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 40

BMI, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Kilogram per square meter (kg/m^2)95% CI
15 mg Tirzepatide or MTD-3.9
4.5 mg Dulaglutide or MTD-1.3
LS Mean difference (Final Values)-2.695% CI-3.1-2.1p<0.0001Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 40

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 40

BMI, change

change from baseline, improvement

Glycemic / diabetes

12 endpoints
Primary/registry result

Change From Baseline in HbA1c

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
15 mg Tirzepatide or MTD-1.59
4.5 mg Dulaglutide or MTD-0.69
LS Mean difference (Final Values)-0.9095% CI-1.10-0.69p<0.0001Mixed Models Analysis
Primary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Who Achieved HbA1c <7%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD84.21
4.5 mg Dulaglutide or MTD52.38
Odds Ratio (OR)7.1395% CI3.8213.32p<0.0001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieved HbA1c <=6.5%

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD73.88
4.5 mg Dulaglutide or MTD22.73
Odds Ratio (OR)12.2495% CI6.5123.02p<0.0001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieved HbA1c <5.7%

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD21.64
4.5 mg Dulaglutide or MTD2.27
Odds Ratio (OR)15.3495% CI4.5851.36p<0.0001Regression, Logistic
Secondary/registry result

Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)

Time frame:Week 40

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders, Documented hypoglycemia, Severe hypoglycemia

Posted result

GroupValue (number), percentage of participants95% CI
15 mg Tirzepatide or MTD46.62
4.5 mg Dulaglutide or MTD4.58
Odds Ratio (OR)20.4495% CI8.4049.77p<0.0001Regression, Logistic
Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), millimole per liter (mmol/L)95% CI
15 mg Tirzepatide or MTD-2.00
4.5 mg Dulaglutide or MTD-1.10
LS Mean difference (Final Values)-0.9095% CI-1.32-0.49p<0.001ANCOVA
Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c <7%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c <=6.5%

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved HbA1c <5.7%

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)

Time frame:Week 40

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders, Documented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Patient-reported / QoL

2 endpoints
Secondary/registry result

Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score

Time frame:Baseline, Week 40

IWQOL-Lite physical

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scale95% CI
15 mg Tirzepatide or MTD11.8
4.5 mg Dulaglutide or MTD7.8
LS Mean difference (Final Values)4.195% CI-1.09.2p0.1181ANCOVA
Secondary/protocol endpoint

Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score

Time frame:Baseline, Week 40

IWQOL-Lite physical

change from baseline, improvement

Publications (2)

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.

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.