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Not yet recruiting

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

Assets

Semaglutide / Tirzepatide

Listed sites

0

Recruiting sites

Enrollment

16

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI 30-45

Primary endpoints

Participant RecruitmentMeal test tolerabilityProtocol completion

Identifiers

Registered as

NCT IDNCT06856928
Org study ID24-1896

Timeline

Milestones

Study first posted2025-03-04actual
Last update posted2025-03-04actual
Study start2025-03estimated (month precision)
Primary completion2026-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age25 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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.

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
5
Cardiometabolic biomarkers
4
Patient-reported / QoL
4
Safety / tolerability / PK
4
Glycemic / diabetes
2
Other clinical outcomes
1

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in insulin (uIU/mL)

Time frame:6-10 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Glucose (mg/dL)

Time frame:6-10 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in leptin (ng/mL)

Time frame:6-10 weeks

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in triglycerides (mg/dL)

Time frame:6-10 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in free fatty acids (uEq/L)

Time frame:6-10 weeks

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Cholesterol (mg/dL)

Time frame:6-10 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Changes in subjective hunger by visual analog scale (VAS)

Time frame:6-10 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in subjective fullness by visual analog scale (VAS)

Time frame:6-10 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:6-10 weeks

change from baseline, improvement

Secondary/protocol endpoint

Disinhibition measured by TFEQ

Time frame:6-10 weeks

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Meal test tolerability

Time frame:6-10 weeks

threshold achievement, descriptive

Primary/protocol endpoint

Rate of protocol completion

Time frame:6-10 weeks

descriptive

Secondary/protocol endpoint/low confidence

Glucose-Dependent Insulinotropic Peptide (pg/mL)

Time frame:6-10 weeks

concentration, descriptive

Secondary/protocol endpoint

Changes in subjective nausea by visual analog scale (VAS)

Time frame:6-10 weeks

Nausea

change from baseline, descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Eating Rate

Time frame:6-10 weeks

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint

Participant Recruitment

Time frame:6-10 weeks

descriptive

Secondary/protocol endpoint/low confidence

Change in peptide YY (pg/ml)

Time frame:6-10 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:6-10 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Glucagon (pg/mL)

Time frame:6-10 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Gastric emptying by acetaminophen

Time frame:6-10 weeks

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.