Tirzepatide for Type 2 Diabetes

(SURPASS-EARLY Trial)

Recruiting at109 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Adults with type 2 diabetes who have been diagnosed within the last 4 years, currently treated only with metformin, and have HbA1c levels between ≥7% to ≤9.5%. They must not be on insulin or other anti-diabetic meds, have a history of certain thyroid cancers or syndromes (MTC/MEN2), pancreatitis, recent cancer treatments (except skin cancer), weight loss surgery, or severe diabetic eye disease.

Inclusion Criteria

I have been taking only metformin for at least 90 days.

I have been taking metformin consistently for over 90 days.

I was diagnosed with type 2 diabetes in the last 4 years.

Exclusion Criteria

I or a family member have had medullary thyroid cancer or MEN2.

I am taking insulin or other medications for diabetes.

I have been diagnosed with pancreatitis before.

Treatment Details

Interventions

• Antihyperglycemic medication (Antihyperglycemic medication)
• Tirzepatide (Glucagon-like peptide-1 receptor agonist)

Trial Overview The trial is testing Tirzepatide's effectiveness and safety against standard care in adults with early-stage type 2 diabetes. Participants will either receive Tirzepatide or intensified conventional antihyperglycemic medication to compare outcomes.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

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

Group II: Intensified Conventional Care Dose Active Control 1 Intervention

Participants will receive an antihyperglycemic medication

Tirzepatide is already approved in Canada for the following indications:

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University