TIA

RecruitingPhase NA

Tirzepatide Impact Assessment Study

Tirzepatide Impact Assessment: Exploring Health and Wellness Outcomes

Lead sponsor

Texas Tech University

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Alcohol / substance use, Eating Disorders, Feeding And Eating Disorders, Obesity / overweight, Psychological Well-Being

Eligibility highlights

Primary endpoints

•Fasting Blood Glucose•LDL Cholesterol•Triglycerides

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07740291

Org study IDIRB2024-370

Timeline

Milestones

Study start2025-01-02actual

Study first posted2026-07-31actual

Last update posted2026-07-31actual

Primary completion2026-11-23estimated

Study completion2026-12-07estimated

Assets

Investigational agents

Semaglutide Tirzepatide

Who this study enrolls

Alcohol / substance useEating DisordersFeeding And Eating DisordersObesity / overweightPsychological Well-Being

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age 18 years or older

•BMI of 27.5 kg/m2 or higher

•For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider

•For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months

Exclusion criteria

•Pregnant

•Breastfeeding

•Wears a pacemaker or other internal medical device

•Chronic kidney disease in the past 2 years

•Active cancer or cancer treatment within the past 6 months

•Current diagnosis of any major endocrine, inflammatory, cardiovascular, or neurological disorder/condition, including Addison's disease, autism, congestive heart failure, Crohn's disease, Cushing's syndrome, hyperparathyroidism, multiple sclerosis, neuromuscular disorders (Guillain-Barre syndrome or myasthenia gravis), stroke, thyroid gland disorders (hyperthyroidism or hypothyroidism), type 1 diabetes, and ulcerative colitis

•Insulin therapy for type 2 diabetes

•For LS comparator arm only: initiating any weight-loss medication (including a GLP-1 receptor agonist) currently or within the past 3 months

Endpoints (26)

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)

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

MASH / liver

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

2 endpoints

Other/protocol endpoint

Change in Body Weight and Body Mass Index (BMI)

Time frame:Baseline and 3 months

change from baseline, improvement

Other/protocol endpoint

Change in Body Composition

Time frame:Baseline and 3 months

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in Fasting Blood Glucose

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint

Change in Fasting Insulin

Time frame:Baseline and 3 months

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Change in Renal and Hepatic Markers

Time frame:Baseline and 3 months

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Change in LDL Cholesterol

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint

Change in Triglycerides

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint

Change in Blood Pressure

Time frame:Baseline and 3 months

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in Health-Related Quality of Life

Time frame:Baseline and 3 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Change in Depressive Symptoms and Suicidal Ideation

Time frame:Time Frame: Baseline and 3 months

change from baseline, event

Other (unclassified)

16 endpoints

Primary/protocol endpoint/low confidence

Change in Disordered Eating

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Food Addiction

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Alcohol Use

Time frame:Time Frame: Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Substance Use

Time frame:Time Frame: Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Anxiety

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Perceived Stress

Time frame:Baseline and 3 months

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Fatigue

Time frame:Baseline and 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Differential Gene Expression Profiles

Time frame:Baseline and 3 months

descriptive

Secondary/protocol endpoint/low confidence

Change in Plasma Metabolomic Signatures

Time frame:Baseline and 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Association Between Gene Expression Changes and Cardiometabolic Outcome Changes

Time frame:Baseline and 3 months

descriptive

Secondary/protocol endpoint/low confidence

Change in Dietary Intake

Time frame:Baseline and 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Physical Activity

Time frame:Baseline and 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Sleep Duration

Time frame:Baseline and 3 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Liver Enzymes

Time frame:Baseline and 3 months

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Resting Metabolic Rate

Time frame:Baseline and 3 months

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Appetite-Related Hormones

Time frame:Baseline and 3 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.