What side effects are associated with this type of intervention?

Common treatments for obesity similar to Tirzepatide, such as GLP-1 receptor agonists (e.g., liraglutide and exenatide), often cause gastrointestinal side effects like nausea, vomiting, and diarrhea. There is also a potential risk of pancreatitis and, based on rodent studies, thyroid C cell tumors, though the significance of this risk in humans is uncertain. These medications are generally not recommended for individuals with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, which are similar to Tirzepatide. Notable examples include Liraglutide and extended-release Exenatide. Liraglutide, administered at a dose of 3 mg daily, has shown significant weight loss in clinical trials, with improvements in cardiometabolic risk factors and quality of life. Extended-release Exenatide, administered once weekly, has also demonstrated efficacy in improving glycemic control and modest weight loss. Both drugs are associated with gastrointestinal side effects, such as nausea and vomiting, which are typically more pronounced during the initial phase of treatment.

What other types of research exist?

Promising alternatives to Tirzepatide for obesity treatment in 2024 include: <ol> <li>Semaglutide: A GLP-1 receptor agonist that has shown significant weight loss in clinical trials.</li> <li></li> </ol> Liraglutide: Another GLP-1 receptor agonist, effective in weight management and improving cardiometabolic risk factors. 3. Exenatide: Available in extended-release formulations, it has been approved for pediatric use and shows promise in weight management. 4. Anamorelin: A ghrelin receptor agonist, showing potential in managing cancer-related cachexia and weight loss. 5. Bupropion/Naltrexone: A combination therapy that targets the central nervous system to reduce appetite and increase energy expenditure.

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

Tirzepatide for Pediatric Obesity

Phase 1

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 168 hours postdose

Summary

This trial is testing a medication called tirzepatide to see if it is safe for children who are overweight. The study will check how their bodies handle the drug over a few months. Tirzepatide helps control blood sugar and may reduce hunger, which can aid in weight loss.

Who is the study for?

This trial is for children with obesity, defined as having a BMI ≥ the 95th percentile for their age and sex. They should have tried losing weight through lifestyle changes without success. Girls must be in early puberty (Tanner Stage 1). It's not for those with certain medical conditions like pancreatitis, other causes of obesity, diabetes, or significant recent weight change.

What is being tested?

The study tests Tirzepatide (LY3298176) against a placebo to see how safe it is and how well kids tolerate it. Researchers will also check how the body handles this drug over about 13 weeks, excluding screening time.

What are the potential side effects?

While specific side effects in pediatric participants are being studied, tirzepatide in adults can cause stomach issues like nausea or vomiting, decreased appetite, diarrhea; potential risk of low blood sugar; and possible injection site reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 168 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 168 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 168 hours postdose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Secondary study objectives

PK: Maximum Concentration (Cmax) of Tirzepatide

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) 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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

Tirzepatide administered subcutaneously (SC)

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered 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

Tirzepatide, a dual GIP and GLP-1 receptor agonist, and other GLP-1 receptor agonists like liraglutide and semaglutide, work by mimicking incretin hormones that are released after eating. These hormones stimulate insulin release, inhibit glucagon secretion, slow gastric emptying, and promote satiety, leading to reduced food intake and weight loss. This is particularly important for obesity patients as these mechanisms help in managing weight and improving metabolic health, thereby reducing the risk of obesity-related complications such as type 2 diabetes and cardiovascular diseases.