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EXER-MED

Not yet recruitingPhase 3

The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)

Lead sponsor

University of Virginia

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07298915

Org study ID302929

Timeline

Milestones

Study first posted2025-12-23actual

Last update posted2026-05-06actual

Study start2026-08estimated (month precision)

Primary completion2026-12estimated (month precision)

Study completion2027-06estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age30 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and women 30-65 years of age, postmenopausal women included

•27-29.9 with an additional CVD risk factor or 30-40 kg/m2

•For overweight adults only: additional cardiometabolic risk factor (diagnosed dyslipidemia, hypertension)

•Willingness and adequate health to go on weight loss medication

•The capability and willingness to provide written informed consent

•Approval of their primary care provider to go on weight loss medication

Exclusion criteria

•Including but not limited to serious arrhythmias

•Cardiomyopathy

•Congestive heart failure

•Stroke or transient ischemic attacks

•Peripheral vascular disease

•Previous history of myocardial infarction or stroke

•Previous diagnosis or taking medication for type 1 or 2 diabetes, fasting glucose >125 mg/dL or HbA1C ≥6.5%

•Systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg.

•Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness

•Conditions that can be aggravated or are contraindicated by exercise training

•Plans to be out of town more than 3 weeks in the next 4 months.

•Currently pregnant or plans to become pregnant

•Currently in a diet or exercise program

•Non-compliance during screening or extreme difficulty in obtaining baseline blood samples

•Enrolled in a different exercise program

•Previous weight loss surgery

•Use of weight loss medication within the last year

•hypo/hyper thyroid (medicated or unmedicated)

Endpoints (15)

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 clinical outcomes

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Other (unclassified)

Weight & body composition

3 endpoints

Primary/protocol endpoint

Weight

Time frame:Baseline and 16 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline to Week 16

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Composition (Fat mass or Lean Mass)

Time frame:Baseline to Week 16

Total fat mass

change from baseline, improvement

componentsTotal fat mass, Lean mass

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in Fasting Glucose Level

Time frame:Baseline to 16 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change in Fasting Insulin Level

Time frame:Baseline to 16 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in hemoglobin A1C

Time frame:Baseline and Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Changes in Blood Lipids Concentrations

Time frame:Baseline to 16 weeks

change from baseline, improvement

componentsLDL-C, change, HDL-C, change, Total cholesterol, change, Triglycerides, change

Secondary/protocol endpoint

Change in Augmentation Index

Time frame:Baseline to 16 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in Blood Pressure (mmHg)

Time frame:Baseline to 16 weeks

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Quality of Life (IWQL-Lite)

Time frame:Baseline to Week 16

IWQOL-Lite total

change from baseline, improvement

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Physical activity level

Time frame:Baseline and 16 weeks

descriptive

Secondary/protocol endpoint

Change in Cardiorespiratory Fitness

Time frame:Baseline and 16 Weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in dietary quality

Time frame:Baseline to Week 16

change from baseline, improvement

Secondary/protocol endpoint

Change in isokinetic dynamometry

Time frame:Baseline and Week 16

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Resting Metabolic Rate

Time frame:Baseline and 16 Weeks

change from baseline, 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.