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Trial · Interventional

Active, not recruitingPhase 4Registry data

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Short name SURPASS-EARLY

NCTNCT05433584 (opens ClinicalTrials.gov in a new tab)Other id17205Other idI8F-MC-GPHEOther id2022-000130-42Other id2022-5010733-40-00

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
780 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
11 countries

United States, Argentina, Canada, Germany, Israel, Italy, Mexico, Puerto Rico, Romania, Slovakia, United Kingdom

Start
1 Aug 2022
Primary completion
21 Oct 2025
Completion
Nov 2027 (estimated)
First posted
27 Jun 2022
Last update posted
12 Dec 2025
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025202620272028
  1. Ph 4

    SURPASS-EARLY

    NCT05433584

    1 Aug 2022 to est. Nov 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Interventions

  • TirzepatideDrug
  • Antihyperglycemic medicationDrug

Arms2

  • Experimental

    Tirzepatide

    Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)

  • Active comparator

    Intensified Conventional Care Dose

    Participants will receive an antihyperglycemic medication

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 104

Secondary outcomes(20)
  1. Change from Baseline in HbA1c

    Time frame · Baseline, Week 208

  2. Change from Baseline in Weight

    Time frame · Baseline, Week 104

  3. Change from Baseline in Weight

    Time frame · Baseline, Week 208

  4. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 104

  5. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 208

  6. Change from Baseline in Fasting Serum Glucose (FSG)

    Time frame · Baseline, Week 104

  7. Change from Baseline in FSG

    Time frame · Baseline, Week 208

  8. Change from Baseline in Lipids

    Time frame · Baseline, Week 104

  9. Change from Baseline in Lipids

    Time frame · Baseline, Week 208

  10. Percentage of Participants Achieving HbA1c <7.0%

    Time frame · Week 104

  11. Percentage of Participants Achieving HbA1c ≤6.5%

    Time frame · Week 104

  12. Percentage of Participants Achieving HbA1c <5.7%

    Time frame · Week 104

  13. Percentage of Participants Achieving HbA1c <7.0%

    Time frame · Week 208

  14. Percentage of Participants Achieving HbA1c ≤6.5%

    Time frame · Week 208

  15. Percentage of Participants Achieving HbA1c <5.7%

    Time frame · Week 208

  16. Change from Baseline in Weight loss of ≥5%,

    Time frame · Baseline, Week 104

  17. Change from Baseline in Weight loss of ≥10%

    Time frame · Baseline, Week 104

  18. Change from Baseline in Weight loss of ≥15%

    Time frame · Baseline, Week 104

  19. Change from Baseline in Weight loss of ≥5%

    Time frame · Baseline, Week 208

  20. Change from Baseline in Weight loss of ≥10%

    Time frame · Baseline, Week 208

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

5 results

Tirzepatide Versus Intensified Conventional Care After 2 Years of Treatment in Early Type 2 Diabetes : A Randomized Clinical Trial.

Del Prato et al. 2026Annals of internal medicine

PMID 42184419DOI 10.7326/annals-25-05602PUB-42184419

Full text at the publisher5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards. * Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory. * Have been on a stable treatment of metformin only at least 90 days preceding baseline * with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or * \<1500 mg/day in case of intolerance of full therapeutic dose. Exclusion Criteria: * Have type 1 diabetes mellitus * Have a history of chronic or acute pancreatitis any time prior to study entry * Have a history of * proliferative diabetic retinopathy * diabetic macular edema, or * no proliferative diabetic retinopathy requiring immediate or urgent treatment * Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry * myocardial infarction * percutaneous coronary revascularization procedure * carotid stenting or surgical revascularization * nontraumatic amputation * peripheral vascular procedure (e.g., stenting or surgical revascularization) * cerebrovascular accident (stroke), or congestive heart failure * 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), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening. * Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and 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.

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