LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy (NCT06885736) | Clinical Trial Compass
RecruitingNot Applicable
LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy
Kuwait232 participantsStarted 2025-08-07
Plain-language summary
The aim of the current study is to determine whether resistance exercise and/or protein intake can preserve lean mass and improve physical function in patients with obesity initiating semaglutide/tirzepatide therapy. To achieve this aim the study will have the following objectives.
In people with obesity initiating semaglutide/tirzepatide therapy
1. Form a PPI group to refine the study protocol and establish study materials,
2. Quantify the effects of a pragmatic resistance exercise intervention and/or increasing protein intake on lean mass and physical function during semaglutide/tirzepatide induced weight loss,
3. Establish whether the resistance exercise intervention and/or increasing protein intake has concomitant benefits on glycaemic control, lipids, liver function, quality of life, physical activity and sleep during semaglutide/tirzepatide induced weight loss.
The participants will:
Begin their weight loss medication, starting at a low dose and then increasing the dose to maximize weight loss. They will be randomly assigned by a computer to ONE of the following groups and will be followed up to 6-months:
* Control group
* Protein intake group
* Muscle strengthening exercise group
* Muscle strengthening exercise AND protein intake group.
Who can participate
Age range
18 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:
* Age \>/= 18 years
* BMI \>/= 27 kg/m2
Exclusion Criteria:
* Currently or in the past 6 months participating in any vigorous aerobic activity (\>1h per week) or any resistance exercise.
* BP of 160/100mmHg or higher
* Any known medical condition that prevents participants from exercising safely
* A personal or family history of medullary thyroid carcinoma
* Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* History of chronic or acute pancreatitis
* History of proliferative diabetic retinopathy or diabetic maculopathy
* History of ketoacidosis or hyperosmolar state/coma
* History of severe hypoglycaemia and/or hypoglycaemia unawareness within last 6 months
* Clinically significant gastric emptying abnormality or have undergone or plan to undergo gastric bypass or restrictive bariatric surgery or chronically taking drugs that directly affect GI motility
* Any of the following CV conditions in last 2 months: acute MI, stroke or hospitilisation due to CHF
* History of NYHA IV CHF
* Acute or chronic hepatitits, signs and symptoms of any liver disease other than NAFLD, ALT \> 3 times the upper limit of normal
* eGFR \<45mL/min/1.73m2
* Significant uncontrolled endocrine abnormaility in the opinion of clinical investigator
* Evidence of active autoimmune abnormality that is likely to requite systemic glucocorticoid treatment in the next 12 months
* Had or waiting for an organ transplant
* History of an active or untreated malignancy or in remission from …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
MRI measured quadriceps cross sectional area (CSA)
Timeframe: From enrollment (at baseline) to the end of treatment at 6 months.