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Type 2 Diabetes MellitusPhase 3SURPASS-1NCT03954834

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

A Phase 3 study testing Tirzepatide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 53 sites in 5 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 goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
478 participants
Where
53 sitesin 5 countries
Study dates
3 Jun 2019to 28 Oct 2020
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).
  • Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
  • Have HbA1c between ≥7.0% and ≤9.5%.
  • Be of stable weight (± 5%) for at least 3 months before screening.
  • Have a BMI ≥23 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 an estimated glomerular filtration rate <30 mL/minute/1.73 m².
  • 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.

Trial locations and contacts

53 sites in 5 countries.

53 sites in 5 countries

United States28 sites

  • Agile Clinical Research Trials

    Atlanta, Georgia, 30328

  • Sky Clinical Research Network

    Atlanta, Georgia, 30331

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Aventiv Research

    Columbus, Ohio, 43213

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • Encore Medical Research, LLC

    Hollywood, Florida, 33021

  • National Research Institute

    Huntington Park, California, 90255

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • National Research Institute

    Los Angeles, California, 90057

  • Axcess Medical Research

    Loxahatchee Groves, Florida, 33470

  • South Florida Wellness & Clinical Research Institute

    Margate, Florida, 33063

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Intend Research

    Norman, Oklahoma, 73069

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Capital Clinical Research Center

    Olympia, Washington, 98502

  • National Research Institute

    Panorama City, California, 91402

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Southern California Dermatology

    Santa Ana, California, 92701

  • Consano Clinical Research

    Shavano Park, Texas, 78231

  • Rockwood Clinic Research Center

    Spokane, Washington, 99220

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

Other trials in United States

Japan10 sites

  • Meiwa Hospital

    Chiyodaku, Tokyo, 101 0041

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0028

  • Takai Naika Clinic

    Kamakura, Kanagawa, 247-0056

  • IHL Shinagawa East One Medical Clinic

    Minato-ku, Tokyo, 108 0075

  • Minamiakatsuka Clinic

    Mito, Ibaraki, 311-4153

  • Sato Naika Clinic

    Ōta-ku, Tokyo, 143-0015

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka, 569-1096

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato, Kanagawa, 242-0004

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa, 232-0064

Other trials in Japan

India9 sites

  • Dr. Jivraj Mehta Smarak Health Foundation

    Ahmedabad, Gujarat, 380007

  • Bangalore Medical College and Research Institute

    Bangalore, Karnataka, 560 002

  • M S Ramaiah Medical College Hospital

    Bangalore, Karnataka, 560054

  • Ramdevrao Hospital

    Hyderabad, Telangana, 500072

  • BSES Municipal General Hsptl

    Mumbai, Maharashtra, 400058

  • Ruby Hall Clinic and Grant Medical Foundation

    Pune, Maharashtra, 411001

  • Gandhi Hospital

    Telangana, 500003

  • Vijay Vallabh Hospital

    Virār, Maharashtra, 401303

  • Lifepoint Multispecialty Hsptl

    Wākad, Pune, 411057

Other trials in India

Mexico4 sites

  • Investigacion en Salud y Metabolismo S.C

    Chihuahua City, 31217

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasc

    Madero, Tamaulipas, 89440

  • Hospital Universitario UANL

    Monterrey, Nuevo León, 64460

  • Unidad Medica para la Salud Integral (UMSI)

    Monterrey, Nuevo León, 66465

Other trials in Mexico

Puerto Rico2 sites

  • GCM Medical Group PSC

    San Juan, PR, 00917

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Three Tirzepatide Doses Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

Being tested
Tirzepatide, Placebo
Keywords
glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), GIP/GLP-1 dual receptor agonist, T2DM
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.

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT03954834
Study groupRoleWhat they receive
5 mg TirzepatideExperimentalParticipants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
Receives: Drug: Tirzepatide
10 mg TirzepatideExperimentalParticipants received 10mg of tirzepatide as subcutaneous injection once a week.
Receives: Drug: Tirzepatide
15 mg TirzepatideExperimentalParticipants received 15mg of tirzepatide as subcutaneous injection once a week.
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorParticipants received placebo as subcutaneous injection once a week.
Receives: Drug: Placebo

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)

    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 + Prior Use of oral antihyperglycemic medication (OAM) (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

Secondary outcomes (8)

  1. 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%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

  2. Percentage of Participants With 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

  3. Change From Baseline in Fasting Serum Glucose

    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%) + Prior Use of OAM (Yes, No) + Treatment + Time + Treatment*Time (Type III sum of squares).

    Measured: Baseline, Week 40

  4. Percentage of Participants With HbA1c Target Value of <5.7%

    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

  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%) + Prior Use of OAM (Yes, No) + 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. 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%) + Prior Use of OAM (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable.

    Measured: Baseline through end of safety follow-up (up to week 44)

  8. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide

    Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide. AUC is a combined measure obtained from Week 7, 15 and 23, and a single averaged measure of AUC was reported.

    Measured: Week 7, 15 and 23

Timeline

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

  1. First posted17 May 2019
  2. Study start3 Jun 2019
  3. Primary completion5 Oct 2020
  4. Study completion28 Oct 2020

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
Double blind
Who is masked
Participant, Investigator
Enrolment
478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03954834
Sponsor's protocol ID
17000
Other IDs
I8F-MC-GPGK
Acronym
SURPASS-1
Status last verified
Oct 2021
First submitted
15 May 2019
Last updated
20 Oct 2021
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

  • 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

  • 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

  • Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021 Jul 10;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6. Epub 2021 Jun 27.

    PubMed 34186022

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirzepatide in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 53 sites in 5 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 8 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Japan, India, Mexico, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 20 Oct 2021). 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) (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 NCT03954834, which also lists 5 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 20 Oct 2021.

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