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

Not yet recruiting

• Conditions: Obesity; Drug

• Registration Number: NCT06856928
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study Start: 2025-03
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant Recruitment	6-10 weeks	Number of participants recruited for the study.
Meal test tolerability	6-10 weeks	Number or participants able to tolerate and complete the test meal.
Rate of protocol completion	6-10 weeks	Percentage of participants enrolled that complete the protocol

Secondary Outcome Measures

Name	Time	Method
Change in peptide YY (pg/ml)	6-10 weeks
Change in Glucagon Like Peptide-1 (pg/mL)	6-10 weeks
Change in leptin (ng/mL)	6-10 weeks
Change in insulin (uIU/mL)	6-10 weeks
Change in Glucagon (pg/mL)	6-10 weeks
Glucose-Dependent Insulinotropic Peptide (pg/mL)	6-10 weeks
Change in Glucose (mg/dL)	6-10 weeks
Change in triglycerides (mg/dL)	6-10 weeks
Change in free fatty acids (uEq/L)	6-10 weeks
Change in Total Cholesterol (mg/dL)	6-10 weeks
Gastric emptying by acetaminophen	6-10 weeks	Peak acetaminophen concentration in blood
Eating Rate	6-10 weeks	Calories/minutes
Changes in subjective hunger by visual analog scale (VAS)	6-10 weeks	Line from 0: not hungry to 10: extremely hungry
Changes in subjective fullness by visual analog scale (VAS)	6-10 weeks	Line from 0: not full to 10: extremely full
Changes in perceived prospective food consumption by visual analog scale (VAS)	6-10 weeks	Line from 0: no desire to eat more to 10: I could eat a large amount.
Changes in subjective nausea by visual analog scale (VAS)	6-10 weeks	Line from 0: no nausea at all more to 10: worst nausea possible.
Disinhibition measured by TFEQ	6-10 weeks	Disinhibition