Clinical trial NCT06856928: Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.
Official title: Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity; Drug
Keywords: appetite-related hormones
appetite
metabolites
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants are residents of the Denver metropolitan area who have either:

1. Had or has obesity and experienced significant weight loss while taking semaglutide or tirzepatide, or
2. Has obesity and has established agreements with their healthcare providers to begin treatment with semaglutide or tirzepatide.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant Recruitment
timeFrame: 6-10 weeks
measure: Meal test tolerability
timeFrame: 6-10 weeks
measure: Rate of protocol completion
timeFrame: 6-10 weeks
Secondary outcomes:
measure: Change in peptide YY (pg/ml)
timeFrame: 6-10 weeks
measure: Change in Glucagon Like Peptide-1 (pg/mL)
timeFrame: 6-10 weeks
measure: Change in leptin (ng/mL)
timeFrame: 6-10 weeks
measure: Change in insulin (uIU/mL)
timeFrame: 6-10 weeks
measure: Change in Glucagon (pg/mL)
timeFrame: 6-10 weeks
measure: Glucose-Dependent Insulinotropic Peptide (pg/mL)
timeFrame: 6-10 weeks
measure: Change in Glucose (mg/dL)
timeFrame: 6-10 weeks
measure: Change in triglycerides (mg/dL)
timeFrame: 6-10 weeks
measure: Change in free fatty acids (uEq/L)
timeFrame: 6-10 weeks
measure: Change in Total Cholesterol (mg/dL)
timeFrame: 6-10 weeks
measure: Gastric emptying by acetaminophen
timeFrame: 6-10 weeks
measure: Eating Rate
timeFrame: 6-10 weeks
measure: Changes in subjective hunger by visual analog scale (VAS)
timeFrame: 6-10 weeks
measure: Changes in subjective fullness by visual analog scale (VAS)
timeFrame: 6-10 weeks
measure: Changes in perceived prospective food consumption by visual analog scale (VAS)
timeFrame: 6-10 weeks
measure: Changes in subjective nausea by visual analog scale (VAS)
timeFrame: 6-10 weeks
measure: Disinhibition measured by TFEQ
timeFrame: 6-10 weeks
Other outcomes:
Locations:
Study officials:
References: