Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT06856928

Opening soonNot applicableObservational

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity; Drug

Full registry 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

Treatments and study arms

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

Participant Recruitment6-10 weeks

Number of participants recruited for the study.

Meal test tolerability6-10 weeks

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

Rate of protocol completion6-10 weeks

Percentage of participants enrolled that complete the protocol

Study locations

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No public site location was included in this record. Check the original registry for updates.