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NCT Number: NCT06856928

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

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.

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Key information

Conditions

Obesity; Drug Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal Challenge

Other

The meal challenge scheduled for 4-6 days after the patient's last injection. The study team will insert an indwelling venous catheter into the participant's forearm for serial blood draws. Immediately prior to the meal, participants will consume 1500 mg of acetaminophen (off-label) to facilitate the analysis of gastric emptying. The participant will then begin the meal challenge by eating the test meal, a breakfast casserole, containing 33% of their current resting energy expenditure needs estimated by Mifflin-ST Jeor equation with a composition of 50% carbohydrate, 30% fat and 20% protein. Participants must completely consume the test meal within 25 minutes of initiating the meal. Participants will fill out behavioral questionnaires after consuming the test meal. After the 2-hour blood draw period, participants will be dismissed. Blood will be drawn prior to the meal and at 5, 10, 15, 30, 60, 90, and 120 minutes after initiating the meal.

Primary outcomes

  1. Participant Recruitment

    Time frame: 6-10 weeks

    Number of participants recruited for the study.

  2. Meal test tolerability

    Time frame: 6-10 weeks

    Number or participants able to tolerate and complete the test meal.

  3. Rate of protocol completion

    Time frame: 6-10 weeks

    Percentage of participants enrolled that complete the protocol

Secondary outcomes

  1. Change in peptide YY (pg/ml)

    Time frame: 6-10 weeks

  2. Change in Glucagon Like Peptide-1 (pg/mL)

    Time frame: 6-10 weeks

  3. Change in leptin (ng/mL)

    Time frame: 6-10 weeks

  4. Change in insulin (uIU/mL)

    Time frame: 6-10 weeks

  5. Change in Glucagon (pg/mL)

    Time frame: 6-10 weeks

  6. Glucose-Dependent Insulinotropic Peptide (pg/mL)

    Time frame: 6-10 weeks

  7. Change in Glucose (mg/dL)

    Time frame: 6-10 weeks

  8. Change in triglycerides (mg/dL)

    Time frame: 6-10 weeks

  9. Change in free fatty acids (uEq/L)

    Time frame: 6-10 weeks

  10. Change in Total Cholesterol (mg/dL)

    Time frame: 6-10 weeks

  11. Gastric emptying by acetaminophen

    Time frame: 6-10 weeks

    Peak acetaminophen concentration in blood

  12. Eating Rate

    Time frame: 6-10 weeks

    Calories/minutes

  13. Changes in subjective hunger by visual analog scale (VAS)

    Time frame: 6-10 weeks

    Line from 0: not hungry to 10: extremely hungry

  14. Changes in subjective fullness by visual analog scale (VAS)

    Time frame: 6-10 weeks

    Line from 0: not full to 10: extremely full

  15. Changes in perceived prospective food consumption by visual analog scale (VAS)

    Time frame: 6-10 weeks

    Line from 0: no desire to eat more to 10: I could eat a large amount.

  16. Changes in subjective nausea by visual analog scale (VAS)

    Time frame: 6-10 weeks

    Line from 0: no nausea at all more to 10: worst nausea possible.

  17. Disinhibition measured by TFEQ

    Time frame: 6-10 weeks

    Disinhibition

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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