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Not yet recruiting NCT06856928

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

— Observational Obesity; Drug

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Meal Challenge.
Who it may be relevant to
Registry conditions: Obesity; Drug. Basic parameters: 25 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Meal Challenge
    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 esti

Primary outcome measures

  • Participant Recruitment [Time frame: 6-10 weeks]
  • Meal test tolerability [Time frame: 6-10 weeks]
  • Rate of protocol completion [Time frame: 6-10 weeks]
Secondary outcome measures (12)
  • Change in peptide YY (pg/ml) [Time frame: 6-10 weeks]
  • Change in Glucagon Like Peptide-1 (pg/mL) [Time frame: 6-10 weeks]
  • Change in leptin (ng/mL) [Time frame: 6-10 weeks]
  • Change in insulin (uIU/mL) [Time frame: 6-10 weeks]
  • Change in Glucagon (pg/mL) [Time frame: 6-10 weeks]
  • Glucose-Dependent Insulinotropic Peptide (pg/mL) [Time frame: 6-10 weeks]
  • Change in Glucose (mg/dL) [Time frame: 6-10 weeks]
  • Change in triglycerides (mg/dL) [Time frame: 6-10 weeks]
  • Change in free fatty acids (uEq/L) [Time frame: 6-10 weeks]
  • Change in Total Cholesterol (mg/dL) [Time frame: 6-10 weeks]
  • Gastric emptying by acetaminophen [Time frame: 6-10 weeks]
  • Eating Rate [Time frame: 6-10 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06856928 · 24-1896

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗