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

NCT ID: NCT07298915

Last Updated: 2025-12-23

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Obesity & Overweight

Keywords

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Obesity Overweight Exercise aerobic resistance training GLP-1 Weight loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Participants will perform aerobic and resistance exercise while taking monthly tirzepatide for 16 weeks

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

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

Exercise

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

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

Intervention Type DRUG

Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Damon Swift

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Central Contacts

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Damon L Swift, Ph.D.

Role: CONTACT

Phone: (434) 924-1436

Email: [email protected]

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