Tirzepatide for Obesity

(SURMOUNT-MMO Trial)

Recruiting at 827 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing tirzepatide, a medication that helps control blood sugar and reduce appetite, to see if it can lower health problems and death rates in adults who are very overweight. Tirzepatide was developed by Eli Lilly to improve blood sugar control in adults with type 2 diabetes.

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 obesity are eligible, specifically those ≥40 years old with cardiovascular disease or older adults with multiple CV risk factors. Participants must have a BMI of ≥27 kg/m² but cannot have diabetes, recent serious heart conditions, pancreatitis, certain cancers in the last 5 years, or significant liver disease.

Inclusion Criteria

I am over 40 with heart disease or at high risk due to my age and health factors.

I am 40 or older with a diagnosed heart condition.

I am over 40 with heart disease or have risk factors for it.

Exclusion Criteria

I have severe stomach emptying issues or have had/planning weight loss surgery (not including liposuction or tummy tuck).

I have a history of medullary thyroid cancer or MEN2 in my family or myself.

I have type 1 or type 2 diabetes, or I've had ketoacidosis or a severe diabetic coma.

Treatment Details

Interventions

• Placebo (Drug)
• Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) and Glucagon Receptor Agonist)

Trial Overview The trial is testing Tirzepatide's effectiveness in reducing health problems and death rates among obese adults compared to a placebo. It aims to provide more evidence for Tirzepatide as a beneficial treatment for this group.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive tirzepatide matched placebo.

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