What is the mechanism of action of this treatment?

The most common treatments for obesity, particularly those similar to Tirzepatide, involve the use of dual GIP and GLP-1 receptor agonists. These medications work by mimicking the incretin hormones, which are released after eating and help regulate insulin secretion, slow gastric emptying, and reduce appetite. By enhancing these natural processes, these treatments can lead to significant weight loss and improved metabolic health. This is crucial for obesity patients as it addresses both weight reduction and the associated comorbidities, such as type 2 diabetes and cardiovascular risks, thereby improving overall health outcomes.

What side effects are associated with this type of intervention?

Common treatments for obesity, particularly GLP-1 receptor agonists like liraglutide and exenatide, often cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. There are also potential risks of pancreatitis and thyroid C cell tumors, although the latter is primarily observed in rodent studies and its relevance to humans remains uncertain. Additional side effects can include injection site reactions and, in rare cases, hypoglycemia when combined with other glucose-lowering drugs.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Liraglutide (Saxenda) was approved for chronic weight management in adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with at least one weight-related condition, such as hypertension or type 2 diabetes. Clinical trials demonstrated significant weight loss and improvements in cardiometabolic risk factors with liraglutide. Another GLP-1 receptor agonist, semaglutide (Wegovy), was also approved for weight management in similar patient populations, showing substantial weight loss in clinical studies. These drugs work by enhancing insulin secretion, reducing appetite, and slowing gastric emptying, which are mechanisms similar to those being studied for Tirzepatide.

What other types of research exist?

Promising alternatives to Tirzepatide for obesity treatment include Liraglutide and Semaglutide, both of which are GLP-1 receptor agonists. Liraglutide has demonstrated significant weight loss in clinical trials, with doses of 2.4 and 3.0 mg showing superior results compared to placebo and orlistat. Semaglutide has also shown efficacy in weight reduction and glycemic control in patients with type 2 diabetes, making it a viable option for obesity management.

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Glucagon-Like Peptide-1 (GLP-1) and Glucagon Receptor Agonist

Tirzepatide for Obesity (SURMOUNT-MMO Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

individuals ≥40 years of age with established cardiovascular disease (CVD).

Coronary artery disease

Must not have

Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma

Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of weight loss drugs like Tirzepatide may include gastrointestinal issues (nausea, diarrhea), low blood sugar levels if diabetic medications are also being taken, and potential thyroid tumors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 or older with a diagnosed heart condition.

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I have been diagnosed with coronary artery disease.

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I have a brain blood vessel condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of pancreatitis.

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

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I have hepatitis or another liver disease, or my liver tests are high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)

Secondary study objectives

Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)

Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)

Kidney Failure, Chronic

+15 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive tirzepatide matched placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for obesity, particularly those similar to Tirzepatide, involve the use of dual GIP and GLP-1 receptor agonists. These medications work by mimicking the incretin hormones, which are released after eating and help regulate insulin secretion, slow gastric emptying, and reduce appetite. By enhancing these natural processes, these treatments can lead to significant weight loss and improved metabolic health. This is crucial for obesity patients as it addresses both weight reduction and the associated comorbidities, such as type 2 diabetes and cardiovascular risks, thereby improving overall health outcomes.