Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Obesity; Drug

Treatments: Other: Meal Challenge

Study type: Observational

Funder types: Other

Identifiers

NCT06856928

24-1896

Details and patient eligibility

About

This study aims to explore how anti-obesity medications (AOMs) like semaglutide and tirzepatide affect appetite and energy intake. Researchers will examine two groups: one just starting AOMs and another that has already achieved significant weight loss and maintained it. By conducting meal challenges at different stages of medication use, the study will assess feasibility of the methods and gather preliminary data to design a larger, future study.

Enrollment: 16 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males and females with a BMI of 30-45 kg/m2 (early group), or a BMI of 30-45 kg/m2 prior to weight loss achieved through medication (late group)
• Age, 25-60 years old
• Passing medical and physical screening, and analysis of blood and urine screening samples
• Anticipated to start or are already prescribed AOMs (semaglutide or tirzepatide)
• 6-months weight stable (early group) or 3 months weight stable at current weight (late group)
• Women of reproductive age must be using an effective form of contraception

Exclusion criteria

• Diagnosed with type 1 or 2 diabetes
• Smoker
• Previous surgical treatment or device-based therapy for obesity
• Chronic or acute pancreatitis
• Clinically significant gastric emptying abnormality
• Uncontrolled hypertension or hypo/hyperthyroidism
• Cardiovascular event 3 months within screening
• Acute or chronic hepatitis
• Inability to tolerate beef, eggs, and cheese
• Women who are pregnant
• Women who are nursing

Trial design

16 participants in 2 patient groups

Early Group

Description:

Participants in the early group are individuals that have established agreements with their clinical providers to begin treatment with semaglutide or tirzepatide as part of their ongoing weight management strategy. These participants will complete a meal challenge before they start the medication and 6 weeks after starting medication.

Treatment:

Other: Meal Challenge

Late Group

Description:

Participants in the late group are individuals that have lost \>12% of their body weight on either semaglutide or tirzepatide and are still taking the medication. These participants will complete a meal challenge before they discontinue medication and 3 weeks after discontinuing the medication.

Treatment:

Other: Meal Challenge