What is the mechanism of action of this treatment?

Common treatments for obesity, such as Tirzepatide, work by targeting hormonal pathways that regulate appetite and glucose metabolism. Tirzepatide is a dual agonist for GIP and GLP-1 receptors, which enhances insulin secretion, reduces glucagon levels, and slows gastric emptying, leading to reduced appetite and increased satiety. Other GLP-1 receptor agonists function similarly by mimicking the incretin hormones, which help to control blood sugar levels and reduce food intake. These mechanisms are important for obesity patients as they address both weight loss and metabolic health, providing a comprehensive approach to treatment.

What side effects are associated with this type of intervention?

Common treatments for obesity, particularly those involving GLP-1 receptor agonists like liraglutide and exenatide, often have side effects such as gastrointestinal symptoms (nausea, vomiting, diarrhea, and constipation). Other potential side effects include an increased risk of pancreatitis, gallbladder disease, and, in rare cases, thyroid tumors. These treatments can also cause hypoglycemia, especially when used in combination with other glucose-lowering medications. It is important for patients to discuss these potential side effects with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, which are similar to tirzepatide. 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. Clinical trials have shown that liraglutide can lead to significant weight loss and improvements in cardiometabolic risk factors. Another GLP-1 receptor agonist, semaglutide (brand name Wegovy), has also been approved for weight management, demonstrating substantial weight loss in clinical trials. These treatments work by mimicking the incretin hormones, which increase insulin secretion and decrease appetite, thereby aiding in weight loss.

What other types of research exist?

Promising alternatives to Tirzepatide for obesity treatment in 2024 include: 1) Semaglutide (GLP-1 receptor agonist), which has shown significant weight loss in clinical trials. 2) Liraglutide (GLP-1 receptor agonist), which has been effective in weight management and improving cardiometabolic risk factors. 3) Combination treatments like Olanzapine/Samidorphan, which can limit weight gain in patients on antipsychotic medications. 4) Bariatric surgery options such as laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass, which are effective for long-term weight loss and metabolic improvements.

← Back to Search

Glucagon-like peptide-1 receptor agonist

Tirzepatide for Obesity

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

Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity (dyslipidemia, pre-hypertension, hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea, prediabetes, documented preexisting condition of Type 2 Diabetes)

Participants with Type 2 Diabetes Mellitus (T2DM) who have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%

Must not have

Have a history of chronic or acute pancreatitis

Have undergone or plan to undergo weight reduction procedure during the study, such as gastric bypass, sleeve gastrectomy, restrictive bariatric surgery (e.g. Lap-Band gastric banding), or any other procedure intended to result in weight reduction.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 72

Awards & highlights

Pivotal Trial

Summary

This trial is testing a weight-loss medication called tirzepatide in teenagers who are overweight or obese and have other health problems related to their weight. The study will last about two years and involve multiple visits. Tirzepatide is effective in treating obesity in patients with and without diabetes.

Who is the study for?

This trial is for adolescents with obesity (BMI ≥95th percentile) or overweight with weight-related issues like high cholesterol, high blood pressure, liver disease, sleep apnea, or prediabetes. Those treated for Type 2 Diabetes with diet/exercise or metformin can join if their HbA1c is below 9.0%.

What is being tested?

The study tests the safety and effectiveness of Tirzepatide, a medication given once weekly to help manage obesity in teens. It's compared against a placebo over about 90 weeks and includes up to 25 visits to check progress.

What are the potential side effects?

Possible side effects of Tirzepatide may include digestive problems like nausea or diarrhea, potential low blood sugar levels especially in those also taking diabetes medications, and possibly thyroid tumors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am overweight according to BMI charts for my age and sex, and I have a weight-related health issue.

Select...

I have Type 2 Diabetes, treated with diet, exercise, or metformin, and my HbA1c is below 9.0%.

Select...

My BMI is in the top 5% for my age and sex.

Exclusion Criteria

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

Select...

I have a history of pancreatitis.

Select...

I have had or plan to have surgery to help me lose weight.

Select...

I have not started puberty.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 72 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide

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 tirzepatide subcutaneously (SC).

Group II: 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 / 7Eligibility 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

Common treatments for obesity, such as Tirzepatide, work by targeting hormonal pathways that regulate appetite and glucose metabolism. Tirzepatide is a dual agonist for GIP and GLP-1 receptors, which enhances insulin secretion, reduces glucagon levels, and slows gastric emptying, leading to reduced appetite and increased satiety. Other GLP-1 receptor agonists function similarly by mimicking the incretin hormones, which help to control blood sugar levels and reduce food intake. These mechanisms are important for obesity patients as they address both weight loss and metabolic health, providing a comprehensive approach to treatment.