What side effects are associated with this type of intervention?

Common treatments for obesity, particularly GLP-1 receptor agonists like liraglutide and exenatide, can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. Other potential side effects include pancreatitis, gallbladder disease, and an increased risk of thyroid C-cell tumors. Injection site reactions and hypoglycemia, especially when combined with other glucose-lowering medications, are also possible.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Liraglutide (brand name Saxenda) is one such drug, 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. Another GLP-1 receptor agonist, semaglutide (brand name Wegovy), has also been approved for weight management in similar patient populations. These drugs work by mimicking the incretin hormone GLP-1, which helps regulate appetite and food intake. While Tirzepatide is a dual GIP and GLP-1 receptor agonist, it is still under investigation for its efficacy and safety in maintaining body weight reduction in individuals with obesity or overweight with weight-related comorbidities.

What other types of research exist?

Promising alternatives to Tirzepatide for obesity treatment include: 1) Liraglutide, a GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. 2) Exenatide, another GLP-1 receptor agonist, approved for pediatric use and showing efficacy in weight management. 3) Bariatric surgery, which remains a highly effective option for significant and sustained weight loss, especially in patients with comorbidities. These alternatives have demonstrated efficacy and safety in various studies and could be considered for obesity treatment in 2024.

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Placebo

Tirzepatide for Weight Loss Maintenance in Obesity

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

Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease

Be older than 18 years old

Must not have

Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma

Have a history of chronic or acute pancreatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 112

Awards & highlights

Pivotal Trial

Summary

This trial is testing tirzepatide, a medication that helps people lose weight, to see if it can also help them keep the weight off. The study involves people who have already lost weight and need help maintaining it. Tirzepatide works by making people feel full and reducing their appetite. Tirzepatide has been effective in helping people lose weight and manage blood sugar levels.

Who is the study for?

This trial is for adults with obesity or overweight who have related health issues like high blood pressure, sleep apnea, or heart disease. They should have tried to lose weight before without success. People with severe depression, diabetes, recent major heart problems, significant weight changes in the last 3 months, pancreatitis, or a family history of certain thyroid cancers cannot join.

What is being tested?

The study tests Tirzepatide's ability to help maintain weight loss compared to a placebo (a treatment with no active drug). Participants will be randomly assigned to receive either Tirzepatide or the placebo and monitored for effectiveness and safety.

What are the potential side effects?

Possible side effects of Tirzepatide may include digestive issues such as nausea and diarrhea, potential low blood sugar levels especially if taking other diabetes medications concurrently, increased heart rate and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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I have diabetes and a history of severe diabetic complications.

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I have a history of pancreatitis.

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I haven't had severe depression or serious mental health issues in the last 2 years.

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I or my family have a history of MTC or MEN-2.

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I haven't had a heart attack, stroke, severe chest pain, or been hospitalized for heart failure in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 112

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 112

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 112 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period

Secondary study objectives

Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization

Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period

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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tirzepatide Maximum Tolerated DoseExperimental Treatment1 Intervention

Participants will receive tirzepatide SC.

Group II: Tirzepatide 5 milligram (mg)Experimental Treatment1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group III: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 6Eligibility 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

Tirzepatide, a dual GIP and GLP-1 receptor agonist, and other GLP-1 receptor agonists work by mimicking incretin hormones that enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. These actions collectively reduce appetite and caloric intake, leading to significant weight loss. For obesity patients, these treatments are important because they address both weight reduction and metabolic improvements, which can help manage obesity-related comorbidities such as type 2 diabetes and cardiovascular diseases.