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Not Yet RecruitingNCT07298915

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

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
University of Virginia · Academic / Other
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGTirzepatideParticipants will take tirzepatide under the care of their primary care provider for 16 weeks
BEHAVIORALExerciseParticipants will perform a combination of aerobic and resistance training for 16 weeks

Timeline

Start date
2026-02-01
Primary completion
2026-12-01
Completion
2027-06-01
First posted
2025-12-23
Last updated
2025-12-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07298915. Inclusion in this directory is not an endorsement.