Tirzepatide for Obesity

(SURMOUNT-5 Trial)

Recruiting at66 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing two weight-loss medications, tirzepatide and semaglutide, in adults who are obese or overweight with health issues related to their weight but do not have Type 2 Diabetes. These medications help reduce appetite and make people feel full sooner, which can lead to weight loss. Semaglutide has been shown to promote significant weight loss and improve health conditions related to obesity.

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

This trial is for adults with obesity or overweight who have unsuccessfully tried to lose weight through diet and have related health issues like high blood pressure, but not diabetes. Participants should have a BMI of ≥30 kg/m², or ≥27 kg/m² with conditions such as hypertension. Those with recent significant weight changes, severe psychiatric disorders, certain endocrine disorders, pancreatitis, or a family history of specific thyroid cancers cannot join.

Inclusion Criteria

My BMI is over 27 and I have a weight-related health issue like high blood pressure or heart disease.

Have a history of at least 1 unsuccessful dietary effort to lose body weight

Exclusion Criteria

I have a history of medullary thyroid cancer or MEN-2 in my family or myself.

I haven't had severe depression or psychiatric issues in the last 2 years.

I have diabetes.

Treatment Details

Interventions

• Semaglutide 2.4 mg (Glucagon-like peptide-1 (GLP-1) receptor agonist)
• Tirzepatide (Glucagon-like peptide-1 (GLP-1) and Glucagon Receptor Agonist)

Trial Overview The study compares the effectiveness and safety of two drugs: Tirzepatide and Semaglutide in individuals without Type 2 Diabetes but who are obese or overweight with related health problems. The trial will run for about 74 weeks to see which drug is better at helping participants lose weight.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group II: Semaglutide Active Control 1 Intervention

Participants will receive semaglutide SC.

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