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Type 2 DiabetesPhase 3SURPASS-2NCT03987919

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

A Phase 3 study testing Tirzepatide and Semaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 127 sites in 9 countries.

Completed

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

Official record
Search all trials

Trial summary

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Tirzepatide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,879 participants
Where
127 sitesin 9 countries
Study dates
30 Jul 2019to 15 Feb 2021
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have been diagnosed with type 2 diabetes mellitus (T2DM)
  • Have HbA1c between ≥7.0% and ≤10.5%
  • Be on stable treatment with unchanged dose of metformin >1500 mg/day for at least 3 months prior to screening
  • Be of stable weight (±5%) for at least 3 months before screening
  • Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Who cannot join

  • 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 acute 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 an estimated glomerular filtration rate <45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Show all 10Show fewer
  • 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 any other diabetes medicines other than metformin during the last 3 months
  • Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Trial locations and contacts

127 sites in 9 countries.

127 sites in 9 countries

United States51 sites

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York, 12206

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Cahaba Research

    Birmingham, Alabama, 35242

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Burke Internal Medicine and Research

    Burke, Virginia, 22015

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • United Osteoporosis Center

    Gainesville, Georgia, 30501

  • PharmQuest

    Greensboro, North Carolina, 27408

  • CMR of Greater New Haven

    Hamden, Connecticut, 06517

  • Biopharma Informatic, Inc.

    Houston, Texas, 77043

  • National Research Institute - Huntington Park

    Huntington Park, California, 90255

  • University of Iowa Hospital & Clinic

    Iowa City, Iowa, 52242

  • East Coast Institute for Research at The Jones Center

    Lake City, Florida, 32055

  • Detweiler Family Medicine & Associates

    Lansdale, Pennsylvania, 19446

  • Green & Seidner Family Practice Associates

    Lansdale, Pennsylvania, 19446

  • South Florida Clinical Research Institute

    Margate, Florida, 33063

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Suncoast Research Group

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165 3338

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • Intend Research, LLC

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Capital Clinical Research Center

    Olympia, Washington, 98502

  • Oviedo Medical Research

    Oviedo, Florida, 32765

  • National Research Institute - Huntington Park

    Panorama City, California, 91402

  • South Broward Research

    Pembroke Pines, Florida, 33027

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania, 15243

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Syed Research Consultants Llc

    Sheffield, Alabama, 35660

  • Clinvest Research LLC

    Springfield, Missouri, 65810

  • Carl R. Meisner Medical Clinic, PLLC

    Sugar Land, Texas, 77478

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

  • Cotton O'Neil Diabetes and Endocrinology Center

    Topeka, Kansas, 66606

  • Premier Research

    Trenton, New Jersey, 08611

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Sky Clinical Research Network

    Union City, Georgia, 30291

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

United Kingdom14 sites

  • Oldfield Surgery

    Bath, Avon, BA2 3HT

  • Oakenhurst Medical Practice

    Blackburn, Gb-lan, BB2 1AX

  • Royal Primary Care Chesterfield North west

    Chesterfield, Gb-dby, S40 4AA

  • Rowden Surgery

    Chippenham, Gb-wil, SN15 2SB

  • University Hospital Coventry & Warwickshire

    Coventry, Warwickshire, CV2 2DX

  • Staploe Medical Centre

    Ely, Gb-cam, CB7 5JD

  • Fowey River Practice

    Fowey, Gb-con, PL23 1DT

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

  • Oak Tree Surgery

    Liskeard, Gb-con, PL14 3XA

  • Knowle House Surgery

    Plymouth, Gb-dev, PL5 3JB

  • Queen Alexandra Hospital

    Portsmouth, Gb-ham, PO6 3LY

  • Wickersley Health Centre - Clifton Medical Centre

    Rotherham, S65 1DA

  • Lister Hospital

    Stevenage, Gb-hrt, SG1 4AB

  • Rame Medical Ltd

    Torpoint, Gb-con, PL11 2TB

Other trials in United Kingdom

Argentina13 sites

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, AR-C, C1179AAB

  • CEMEDIAB

    C.a.b.a., AR-C, C1205AAO

  • CEDIC

    CABA, AR-B, C1425DES

  • Centro de Investigaciones Metabólicas (CINME)

    CABA, Buenos Aires, C1056ABJ

  • Centro Médico Viamonte

    CABA, Buenos Aires, C1120AAC

  • Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

    CABA, Buenos Aires, C1425AGC

  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

    Ciudad Autonoma de Buenos Air, Buenos Aires, C1128AAF

  • CIPREC

    Ciudad Autonoma de Buenos Aire, AR-B, C1119ACN

  • Instituto Centenario

    Ciudad Autonoma de Buenos Aire, C1204AAD

  • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

    Córdoba, X5008HHW

  • CIPADI

    Godoy Cruz, Mendoza Province, M5501ARP

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, (B7600FZN)

  • Sanatorio Norte

    Santiago del Estero, AR-G, 4200

Other trials in Argentina

Australia13 sites

  • Paratus Clinical Research Western Sydney

    Blacktown, Au-nsw, 2148

  • Eastern Clinical Research Unit

    Box Hill, Victoria, 3128

  • GenesisCare - Bundaberg

    Bundaberg, Queensland, 4670

  • Campbelltown Medical & Dental Centre

    Campbelltown, Au-nsw, 2560

  • Barwon Health - The Geelong Hospital

    Geelong, Victoria, 3220

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4029

  • GenesisCare - Wexford Medical Centre WA

    Joondalup, Western Australia, 6027

  • Paratus Clinical Research Central Coast

    Kanwal, Au-nsw, 2259

  • Core Research Group

    Milton, Queensland, 4064

  • GenesisCare - Wexford Medical Centre WA

    Murdoch, Western Australia, 6150

  • Holdsworth House Medical Practice

    Sydney, New South Wales, 2010

  • AusTrials

    Taringa, Queensland, 4068

  • Adelaide Medical Solutions

    Woodville South, 5011

Other trials in Australia

Israel9 sites

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601

  • Linn Medical Center

    Haifa, Ḥeifā, 3515209

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Clalit Health Services - Shuali Clinic

    Raanana, Central District, 43405

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100

  • Clalit Health Services - Sakhnin Community Clinic

    Sakhnin, 3081000

  • Diabetes Medical Center

    Tel Aviv, Il-ta, 51549

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Canada8 sites

  • Manna Research - Burlington North

    Burlington, Ontario, L7M 4Y1

  • Manna Research

    Lévis, Ca-qc, G6W 0M5

  • Milestone Research Inc.

    London, Ca-on, N5W 6A2

  • Manna Research - Burlington North

    Nepean, Ontario, K2J 4A7

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ca-on, N7T 4X3

  • Manna Research - Burlington North

    Stoney Creek, Ontario, L8J 3W2

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ca-on, M9V 4B4

  • Manna Research - Burlington North

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Mexico8 sites

  • Investigacion en Salud y Metabolismo S.C

    Chihuahua City, 31238

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, Tamaulipas, 89440

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco, 44130

  • Instituto Jalisciense de Investigacion en Diabetes y Obesida

    Guadalajara, Jalisco, 44600

  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

    Guadalajara, Mx-jal, 44150

  • Centro Especializado en Diabetes Obesidad y Enfermedades

    México, D.F., 11650

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, N.L., 64460

  • Unidad Médica para la Salud Integral

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

Brazil7 sites

  • Centro de Pesquisas em Diabetes

    Porto Alegre, Rio Grande do Sul, 90430-001

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, Br-sp, 12243-280

  • CPQuali Pesquisa Clínica

    São Paulo, Br-sp, 01228-000

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, Br-sp, 04266-010

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • Dr. Consulta Clínica Médica LTDA

    São Paulo, 05016-090

  • CEDOES

    Vitória, Br-es, 29055450

Other trials in Brazil

Puerto Rico4 sites

  • Paola Mansilla-Letelier, MD

    Guaynabo, PR, 00970

  • Research and Cardiovascular Corp.

    Ponce, PR, 00717

  • Martha Gomez Cuellar M.D.

    San Juan, PR, 00921

  • Clinical Research Puerto Rico

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Conditions
Type 2 Diabetes
Keywords
T2DM, GLP-1 RA, Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist
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.

Study groups in NCT03987919
Study groupRoleWhat they receive
5 mg TirzepatideExperimental5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Receives: Drug: Tirzepatide
10 mg TirzepatideExperimental10 mg tirzepatide administered SC once a week.
Receives: Drug: Tirzepatide
15 mg TirzepatideExperimental15 mg tirzepatide administered SC once a week.
Receives: Drug: Tirzepatide
1 mg SemaglutideActive comparator1 mg semaglutide administered SC once a week.
Receives: Drug: Semaglutide

What is being measured

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

  1. Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

Secondary outcomes (9)

  1. Change From Baseline in HbA1c (5 mg)

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

  2. Change From Baseline in Body Weight

    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

  3. Percentage of Participants Achieving an HbA1c Target Value of <7%

    Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Measured: Week 40

  4. Change From Baseline in Fasting Serum Glucose (FSG)

    Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

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

    The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

  6. Percentage of Participants Who Achieved Weight Loss ≥5%

    Percentage of Participants who Achieved Weight Loss ≥5%.

    Measured: Week 40

  7. Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score

    DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment (Type III sum of squares).

    Measured: Baseline, Week 40

  8. Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia

    The hypoglycemia events were defined by participant reported events with blood glucose <54mg/dL) (<3.0 mmol/L] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Treatment.

    Measured: Baseline through Safety Follow-Up (Up to Week 44)

  9. Percentage of Participants Achieving an HbA1c Target Value of <5.7%

    Percentage of Participants Achieving an HbA1c Target Value of <5.7%.

    Measured: Week 40

Timeline

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

  1. First posted17 Jun 2019
  2. Study start30 Jul 2019
  3. Primary completion28 Jan 2021
  4. Study completion15 Feb 2021

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,879 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987919
Sponsor's protocol ID
17001
Other IDs
I8F-MC-GPGL, 2018-004422-29, 2018
Acronym
SURPASS-2
Status last verified
Jul 2021
First submitted
14 Jun 2019
Last updated
14 Feb 2022
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.

Publications

  • De Block C, Peleshok J, Wilding JPH, Kwan AYM, Rasouli N, Maldonado JM, Wysham C, Liu M, Aleppo G, Benneyworth BD. Post Hoc Analysis of SURPASS-1 to -5: Efficacy and Safety of Tirzepatide in Adults with Type 2 Diabetes are Independent of Baseline Characteristics. Diabetes Ther. 2025 Jan;16(1):43-71. doi: 10.1007/s13300-024-01660-0. Epub 2024 Nov 12.

    PubMed 39531161

  • Osumili B, Fan L, Paik JS, Pantalone KM, Ranta K, Sapin H, Tofe S. Tirzepatide 5, 10 and 15 mg versus injectable semaglutide 0.5 mg for the treatment of type 2 diabetes: An adjusted indirect treatment comparison. Diabetes Res Clin Pract. 2024 Jun;212:111717. doi: 10.1016/j.diabres.2024.111717. Epub 2024 May 21.

    PubMed 38777128

  • Boye KS, Sapin H, Dong W, Williamson S, Lee CJ, Thieu VT. Improved Glycaemic and Weight Management Are Associated with Better Quality of Life in People with Type 2 Diabetes Treated with Tirzepatide. Diabetes Ther. 2023 Nov;14(11):1867-1887. doi: 10.1007/s13300-023-01457-7. Epub 2023 Sep 5.

    PubMed 37668888

  • Boye KS, Thieu VT, Sapin H, Lee CJ, Lando LF, Brown K, Bray R, Wiese RJ, Patel H, Rodriguez A, Yu M. Patient-Reported Outcomes in People with Type 2 Diabetes Receiving Tirzepatide in the SURPASS Clinical Trial Programme. Diabetes Ther. 2023 Nov;14(11):1833-1852. doi: 10.1007/s13300-023-01451-z. Epub 2023 Aug 1.

    PubMed 37526908

  • Reitzel SB, Bogelund M, Basse A, Barszczewska O, Ren H. Semaglutide versus tirzepatide for people with type 2 diabetes: cost of glycemic control in Austria, the Netherlands, Lithuania, and the United Arab Emirates. Curr Med Res Opin. 2023 Aug;39(8):1055-1060. doi: 10.1080/03007995.2023.2231275. Epub 2023 Jul 10.

    PubMed 37415503

  • Viljoen A, Pantalone KM, Galindo RJ, Cui X, Huh R, Hemmingway A, Fernandez Lando L, Patel H. Time to Reach Glycaemic and Body Weight Loss Thresholds with Tirzepatide in Patients with Type 2 Diabetes: A Pre-planned Exploratory Analysis of SURPASS-2 and SURPASS-3. Diabetes Ther. 2023 May;14(5):925-936. doi: 10.1007/s13300-023-01398-1. Epub 2023 Mar 31.

    PubMed 37000390

  • Ten Doesschate T, van der Vaart TW, Debisarun PA, Taks E, Moorlag SJCFM, Paternotte N, Boersma WG, Kuiper VP, Roukens AHE, Rijnders BJA, Voss A, Veerman KM, Kerckhoffs APM, Oever JT, van Crevel R, van Nieuwkoop C, Lalmohamed A, van de Wijgert JHHM, Netea MG, Bonten MJM, van Werkhoven CH. Bacillus Calmette-Guerin vaccine to reduce healthcare worker absenteeism in COVID-19 pandemic, a randomized controlled trial. Clin Microbiol Infect. 2022 Sep;28(9):1278-1285. doi: 10.1016/j.cmi.2022.04.009. Epub 2022 Apr 28.

    PubMed 35489606

  • Sattar N, McGuire DK, Pavo I, Weerakkody GJ, Nishiyama H, Wiese RJ, Zoungas S. Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Nat Med. 2022 Mar;28(3):591-598. doi: 10.1038/s41591-022-01707-4. Epub 2022 Feb 24.

    PubMed 35210595

  • Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.

    PubMed 34170647

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide and Semaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 127 sites in 9 countries.

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 5 inclusion and 10 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 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, United Kingdom, Argentina, Australia, Israel and 4 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Feb 2022). 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 Hemoglobin A1c (HbA1c) (10 mg and 15 mg) (time frame: Baseline, Week 40). 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 NCT03987919, which also lists 9 linked publications.

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 14 Feb 2022.

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