What side effects are associated with this type of intervention?

Common treatments for obesity, particularly GLP-1 receptor agonists like liraglutide and semaglutide, can 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 is uncertain. Other side effects may include injection site reactions and gallbladder-related issues like cholelithiasis.

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 comorbidity. Clinical trials demonstrated significant weight loss and improvements in cardiometabolic risk factors. 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 mimicking the incretin hormone GLP-1, which increases insulin secretion, slows gastric emptying, and reduces appetite.

What other types of research exist?

Promising alternatives to Tirzepatide for obesity treatment include Semaglutide (a GLP-1 receptor agonist) and Liraglutide (another GLP-1 receptor agonist). Both have shown significant weight loss in clinical trials. Additionally, new medications like Anamorelin, a ghrelin receptor agonist, are being explored for their potential in managing weight loss in patients with cachexia, which may extend to broader obesity treatment in the future.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Tirzepatide for Obesity (SURMOUNT-5 Trial)

Phase 3

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive issues like nausea and diarrhea, possible inflammation of the pancreas (pancreatitis), allergic reactions, changes in heart rate or mood swings. Each person's experience can vary.

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

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TirzepatideExperimental Treatment1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group II: SemaglutideActive Control1 Intervention

Participants will receive semaglutide SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

Do I qualify?Apply below to find out

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

Common treatments for obesity, such as Tirzepatide (a dual GIP and GLP-1 receptor agonist), Semaglutide, and Liraglutide, work by mimicking incretin hormones that are released after eating. These hormones stimulate insulin release, inhibit glucagon secretion, slow gastric emptying, and reduce appetite. This multi-faceted approach helps patients achieve significant weight loss by improving glucose metabolism and reducing caloric intake, which is essential for managing obesity and its related comorbidities.