Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Musc… (NCT07609160) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
108 participantsStarted 2026-11-01
Plain-language summary
This randomized controlled trial aims to investigate the effects of a 24-week home-based progressive resistance exercise program combined with tirzepatide treatment on skeletal muscle mass, muscle quality, and functional capacity in overweight and obese individuals. A total of 108 participants initiating tirzepatide therapy will be randomized to either exercise plus pharmacotherapy or pharmacotherapy alone. The primary outcome is change in thigh muscle thickness and echo intensity assessed by ultrasonography.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* initiation of tirzepatide-based pharmacological treatment as prescribed by an endocrinology and metabolism specialist,
* body mass index (BMI) ≥27 kg/m² and the presence of a comorbidity condition or BMI≥30 kg/m²
* age between 18 and 65 years
Exclusion Criteria:
* diagnosis of type 1 or type 2 diabetes mellitus
* presence of cerebrovascular, hematological, pulmonary, rheumatological, or neurological disorders
* current participation in a structured diet or exercise program
* use of weight-loss medications within the past 12 months
* history of upper or lower extremity surgery or injury within the past 6 months
* any contraindication to resistance exercise as determined by the treating physician.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines a GLP-1/GIP dual agonist medication with structured exercise — could you help me understand what that medication actually is, how it works, and whether it would be appropriate given my specific health situation?
2Since this trial is not yet recruiting, how long might it realistically be before enrollment opens, and would waiting for it delay any treatment I should be starting now?
3The trial is measuring changes in muscle thickness and muscle echo intensity — can you explain why those muscle measurements matter for someone who is overweight or obese, and whether I might already have signs of muscle loss that make this relevant to me?
4This study is specifically for overweight and obese people without Type 2 Diabetes — does my current health profile fit that description closely enough to even make sense discussing this trial further with you?
5Given that this is listed as Phase NA, meaning it may be more of an observational or feasibility study rather than a late-stage treatment trial, would you recommend I also look into standard treatments for weight management and muscle health while I wait to see if this trial becomes available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.