Obesity; DrugNCT06856928
Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.
An observational study of Obesity; Drug, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity; Drug
- What is being tested?
- Meal Challenge
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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.
- Conditions
- Obesity; Drug
- Being tested
- Meal Challenge
- Keywords
- appetite-related hormones, appetite, metabolites
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal ChallengeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Group | Participants in the early group are individuals that have established agreements with their clinical providers to begin treatment with semaglutide or tirzepatide as part of their ongoing weight management strategy.
These participants will complete a meal challenge before they start the medication and 6 weeks after starting medication. Receives: Other: Meal Challenge | |
| Late Group | Participants in the late group are individuals that have lost >12% of their body weight on either semaglutide or tirzepatide and are still taking the medication.
These participants will complete a meal challenge before they discontinue medication and 3 weeks after discontinuing the medication. Receives: Other: Meal Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment
Number of participants recruited for the study.
Measured: 6-10 weeks
Meal test tolerability
Number or participants able to tolerate and complete the test meal.
Measured: 6-10 weeks
Rate of protocol completion
Percentage of participants enrolled that complete the protocol
Measured: 6-10 weeks
Secondary outcomes (17)
Change in peptide YY (pg/ml)
Measured: 6-10 weeks
Change in Glucagon Like Peptide-1 (pg/mL)
Measured: 6-10 weeks
Change in leptin (ng/mL)
Measured: 6-10 weeks
Change in insulin (uIU/mL)
Measured: 6-10 weeks
Change in Glucagon (pg/mL)
Measured: 6-10 weeks
Glucose-Dependent Insulinotropic Peptide (pg/mL)
Measured: 6-10 weeks
Change in Glucose (mg/dL)
Measured: 6-10 weeks
Change in triglycerides (mg/dL)
Measured: 6-10 weeks
Change in free fatty acids (uEq/L)
Measured: 6-10 weeks
Change in Total Cholesterol (mg/dL)
Measured: 6-10 weeks
Gastric emptying by acetaminophen
Peak acetaminophen concentration in blood
Measured: 6-10 weeks
Eating Rate
Calories/minutes
Measured: 6-10 weeks
Changes in subjective hunger by visual analog scale (VAS)
Line from 0: not hungry to 10: extremely hungry
Measured: 6-10 weeks
Changes in subjective fullness by visual analog scale (VAS)
Line from 0: not full to 10: extremely full
Measured: 6-10 weeks
Changes in perceived prospective food consumption by visual analog scale (VAS)
Line from 0: no desire to eat more to 10: I could eat a large amount.
Measured: 6-10 weeks
Changes in subjective nausea by visual analog scale (VAS)
Line from 0: no nausea at all more to 10: worst nausea possible.
Measured: 6-10 weeks
Disinhibition measured by TFEQ
Disinhibition
Measured: 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; DrugStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ezpeleta, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856928
- Sponsor's protocol ID
- 24-1896
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.
- ClinicalTrials.gov ID
- NCT06856928
- Acronym / sponsor ID
- 24-1896
- Conditions
- Obesity; Drug
- Keywords
- appetite-related hormones, appetite, metabolites
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Group | – | Other: Meal ChallengeParticipants in the early group are individuals that have established agreements with their clinical providers to begin treatment with semaglutide or tirzepatide as part of their ongoing weight management strategy. These participants will complete a meal challenge before they start the medication and 6 weeks after starting medication. |
| Late Group | – | Other: Meal ChallengeParticipants in the late group are individuals that have lost >12% of their body weight on either semaglutide or tirzepatide and are still taking the medication. These participants will complete a meal challenge before they discontinue medication and 3 weeks after discontinuing the medication. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal ChallengeThe 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. | Other | Early Group, Late Group |
Primary outcome
Participant Recruitment
Time frame: 6-10 weeks
Number of participants recruited for the study.
Meal test tolerability
Time frame: 6-10 weeks
Number or participants able to tolerate and complete the test meal.
Rate of protocol completion
Time frame: 6-10 weeks
Percentage of participants enrolled that complete the protocol
17 secondary outcomes
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
Changes in subjective hunger by visual analog scale (VAS)
Time frame: 6-10 weeks
Changes in subjective fullness by visual analog scale (VAS)
Time frame: 6-10 weeks
Changes in perceived prospective food consumption by visual analog scale (VAS)
Time frame: 6-10 weeks
Changes in subjective nausea by visual analog scale (VAS)
Time frame: 6-10 weeks
Disinhibition measured by TFEQ
Time frame: 6-10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity; Drug, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment (time frame: 6-10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.