Tirzepatide Impact Assessment Study

NCT07740291 | Recruiting

• 1 other identifier: IRB2024-370
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months. At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study. The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas. Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications. Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.

Conditions

Obesity & Overweight; Cardiometabolic Health Indicators; Addiction; Eating Disorders; Mental Health

Keywords

GLP-1 receptor agonists; obesity; Multi-omics profiling; Semaglutide; Tirzepatide; Appetite Regulation; Addictive Behaviors; eating disorders; appetite-related hormones; mental health

Outcome Measures

Primary Outcomes (13)

• Change in Fasting Blood Glucose

  Fasting serum blood glucose measured from venipuncture sample and analyzed as part of the basal metabolic panel. Used as the reference outcome for power estimation; a between-group difference of 4.71 mg/dL was the minimum detectable effect based on a prior semaglutide meta-analysis (SD = 9.9 mg/dL).

  Baseline and 3 months

• Change in LDL Cholesterol

  Serum LDL cholesterol measured from a fasting venipuncture sample. A decrease of 10% or more from baseline is considered clinically meaningful.

  Baseline and 3 months

• Change in Triglycerides

  Serum triglycerides measured from fasting venipuncture sample. A decrease of 30% or more from baseline is considered clinically meaningful.

  Baseline and 3 months

• Change in Fasting Insulin

  Serum fasting insulin measured from venipuncture sample. Used alongside fasting glucose to characterize insulin resistance.

  Baseline and 3 months

• Change in Blood Pressure

  Systolic and diastolic blood pressure measured using a digital monitor after a five-minute rest period. The average of two readings taken five minutes apart is recorded.

  Baseline and 3 months

• Change in Disordered Eating

  Disordered eating characteristics including dietary restraint, eating concern, shape concern, and weight concern assessed using the Eating Disorder Examination Questionnaire (EDE-Q) administered via Qualtrics.

  Baseline and 3 months

• Change in Food Addiction

  Food addiction symptom count and severity assessed using the Modified Yale Food Addiction Scale Version 2.0 (mYFAS 2.0) administered via Qualtrics.

  Baseline and 3 months

• Change in Alcohol Use

  Alcohol use frequency, quantity, and disorder risk assessed using the Alcohol Use Disorders Identification Test (AUDIT) and a 30-day frequency and quantity measure administered via Qualtrics.

  Time Frame: Baseline and 3 months

• Change in Substance Use

  Tobacco and other substance use assessed using the Lifetime Smoking Questionnaire and a 30-day frequency and quantity of substance use measure administered via Qualtrics.

  Time Frame: Baseline and 3 months

• Change in Depressive Symptoms and Suicidal Ideation

  Depressive symptom severity and suicidal ideation assessed using the Patient Health Questionnaire-9 (PHQ-9) administered via Qualtrics.

  Time Frame: Baseline and 3 months

• Change in Anxiety

  Generalized anxiety symptom severity assessed using the Generalized Anxiety Disorder-7 (GAD-7) administered via Qualtrics.

  Baseline and 3 months

• Change in Perceived Stress

  Perceived psychological stress assessed using the Perceived Stress Scale (PSS) administered via Qualtrics.

  Baseline and 3 months

• Change in Fatigue

  Fatigue severity assessed using the Fatigue Assessment Scale (FAS) administered via Qualtrics.

  Baseline and 3 months

Secondary Outcomes (9)

• Differential Gene Expression Profiles

  Baseline and 3 months

• Change in Plasma Metabolomic Signatures

  Baseline and 3 months

• Association Between Gene Expression Changes and Cardiometabolic Outcome Changes

  Baseline and 3 months

• Change in Dietary Intake

  Baseline and 3 months

• Change in Physical Activity

  Baseline and 3 months

Other Outcomes (4)

• Change in Body Weight and Body Mass Index (BMI)

  Baseline and 3 months

• Change in Body Composition

  Baseline and 3 months

• Change in Resting Metabolic Rate

  Baseline and 3 months

Study Arms (2)

GLP-1 Receptor Agonist (Semaglutide or Tirzepatide)

EXPERIMENTAL

Individuals in this study arm will be prescribed semaglutide or tirzepatide for weight management by their primary medical provider. Individuals will be invited to enroll in the study if they are starting semaglutide or tirzepatide within 0-3 days of coming into the NMHI clinic for their baseline assessment.

Drug: GLP-1 Receptor Agonist Therapy

Lifestyle Comparator Arm

ACTIVE COMPARATOR

Participants receive a structured lifestyle intervention delivered by a nutritional sciences graduate student and developed by a Registered Dietitian. The intervention targets a 500 kcal daily deficit from measured total energy expenditure and 150 to 300 minutes of moderate-intensity physical activity per week. Three individual education sessions are provided at baseline, one month, and two months. Dietary adherence is monitored via MyFitnessPal or a food journal. The same physical assessments and biospecimen collection procedures as the GLP-1 RA arm are completed at baseline and three months.

Behavioral: Structured Lifestyle Intervention

Interventions

GLP-1 Receptor Agonist Therapy DRUG

Participants receive semaglutide or tirzepatide as prescribed by their own medical provider prior to study enrollment. Dosing and titration followed the prescribing provider's clinical judgment and are not controlled by the study team. Both medications are GLP-1 receptor agonists approved for weight management and glycemic control; tirzepatide additionally acts on the glucose-dependent insulinotropic polypeptide (GIP) receptor.

GLP-1 Receptor Agonist (Semaglutide or Tirzepatide)

Structured Lifestyle Intervention BEHAVIORAL

A reduced-calorie diet providing a 500 kcal daily deficit from individually calculated total energy expenditure, combined with a goal of 150 to 300 minutes of moderate-intensity physical activity per week. Total energy expenditure is estimated by multiplying each participant's measured resting metabolic rate (MedGem indirect calorimetry) by a standard physical activity factor. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Three individual counseling sessions are delivered over three months in person or via a HIPAA-secured video platform.

Lifestyle Comparator Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Nutrition Metabolic Health Initiative (NMHI)

Lubbock, Texas, 79410, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Behavior, Addictive; Feeding and Eating Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior; Signs and Symptoms, Digestive; Mental Disorders; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Non-randomized parallel-group design. Participants self-select into one of two arms based on their clinical care: a GLP-1 receptor agonist arm (semaglutide or tirzepatide initiated by their own medical provider) and a structured lifestyle intervention comparator arm. Both arms follow the same assessment schedule over three months.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: January 2, 2025
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)