Clinical trial

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

Opening soon · Phase 3 · 1 countries · Registry ID NCT07298915

Opening soonPhase 3Interventional

What this study is about

This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity. 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry criteria

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)

Treatments and study arms

Tirzepatide

Drug

Participants will take tirzepatide under the care of their primary care provider for 16 weeks

Exercise

Behavioral

Participants will perform a combination of aerobic and resistance training for 16 weeks

Primary outcomes

WeightBaseline and 16 Weeks

Measurement will be taken 3 times and measured in kg. A positive value indicates an increase in weight and a negative value indicates a reduction in weight

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Virginia🇺🇸 Charlottesville, Virginia, United States

Open map

Damon L Swift, Ph.D.Contact

Call (434) 924-1436

Damon L Swift, Ph.D.Principal Investigator

Catherine Varney, DOSub Investigator