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

Last updated: December 19, 2025
Sponsor: University of Virginia
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

Tirzepatide

Exercise

Clinical Study ID

NCT07298915
302929
  • Ages 30-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 (diagnoseddyslipidemia, 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

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 undergoingtreatment 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 bloodsamples

  • 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)

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
February 01, 2026
Estimated Completion Date:
June 30, 2027

Study Description

The new type class of weight loss medications called GLP-1 medications have been shown to cause weight loss and improve risk factors for heart disease and diabetes. One thing that is currently unknown is whether exercise augments the impact of weight loss in people taking GLP-1 medication. The EXER-MED study is a pilot study evaluating the effect of 16 weeks of exercise training with GLP-1 medication compared to taking the medication alone. We will evaluate the impact of the study groups on weight, body composition (percent fat, percent lean mass), blood pressure, arterial stiffness, blood work (cholesterol, blood pressure, glucose, insulin) and quality of life.

Connect with a study center

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22901
    United States

    Site Not Available

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