The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)
NCT ID: NCT07298915
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
24 participants
INTERVENTIONAL
2026-02-28
2027-06-30
Brief Summary
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The main questions it will answer includes:
* Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone
* Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life
Participants will:
* Take a weight loss medication (tirzepatide) monthly under the supervision of their primary care physician
* (Exercise group only) Will perform exercise \~3 times a week at the University of Virginia). Walking on a treadmill and resistance training
* Visit the study site at the beginning of the study and after the study to evaluate weight, body fat, and other health measures
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise
Participants will perform aerobic and resistance exercise while taking monthly tirzepatide for 16 weeks
Tirzepatide
Participants will take tirzepatide under the care of their primary care provider for 16 weeks
Exercise
Participants will perform a combination of aerobic and resistance training for 16 weeks
Standard Care
Participants will take monthly Tirzepatide under the care of their primary care provider for 16 weeks
Tirzepatide
Participants will take tirzepatide under the care of their primary care provider for 16 weeks
Interventions
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Tirzepatide
Participants will take tirzepatide under the care of their primary care provider for 16 weeks
Exercise
Participants will perform a combination of aerobic and resistance training for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
65 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Damon Swift
Associate Professor
Principal Investigators
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Damon L Swift, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Damon L Swift, Ph.D.
Role: primary
Other Identifiers
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302929
Identifier Type: -
Identifier Source: org_study_id