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

NCT07298915 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 302929
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obesity & Overweight

Keywords

Obesity; Overweight; Exercise; aerobic; resistance training; GLP-1; Weight loss

Outcome Measures

Primary Outcomes (1)

• Weight

  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

  Baseline and 16 Weeks

Secondary Outcomes (14)

• Physical activity level

  Baseline and 16 weeks

• Changes in Blood Lipids Concentrations

  Baseline to 16 weeks

• Resting Metabolic Rate

  Baseline and 16 Weeks

• Change in Fasting Glucose Level

  Baseline to 16 Weeks

• Change in Fasting Insulin Level

  Baseline to 16 Weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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

Drug: Tirzepatide; Behavioral: Exercise

Standard Care

ACTIVE COMPARATOR

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

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

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

Exercise; Standard Care

Exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 30-65 years of age, postmenopausal women included
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22901, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity; Weight Loss

Interventions

Tirzepatide; Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Damon L Swift, Ph.D

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damon L Swift, Ph.D.

CONTACT

(434) 924-1436; dls3s@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: December 23, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)