Keeping lean muscle during semaglutide or tirzepatide with resistance exercise and extra protein
LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide and Tirzepatide Therapy (LEAN-PREP Study)
This trial will test whether adding a practical resistance exercise program and higher protein intake helps adults with obesity keep lean muscle and stay stronger when they start semaglutide or tirzepatide treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dasman Diabetes Institute Academic / other |
| Locations | 1 site (Kuwait City) |
| Trial ID | NCT06885736 on ClinicalTrials.gov |
What this trial studies
Adults with obesity who are starting semaglutide or tirzepatide will be enrolled and asked to follow a pragmatic resistance exercise program and/or increase their protein intake while their medication dose is titrated. A patient and public involvement (PPI) group will help refine the protocol and study materials. The study will measure changes in lean mass and physical function and will also track effects on blood sugar, lipids, liver tests, quality of life, activity and sleep. Interventions are behavioral (exercise and dietary protein) delivered alongside standard medication care.
Who should consider this trial
Good fit: Adults aged 18 or older with BMI ≥27 kg/m2 who are starting semaglutide or tirzepatide and are not already doing regular resistance exercise are the intended candidates.
Not a fit: People who already perform regular resistance training, who cannot safely exercise, or who have contraindications to increased protein intake are less likely to benefit from these interventions.
Why it matters
Potential benefit: If successful, participants could lose less muscle and preserve strength while benefiting from weight loss on semaglutide or tirzepatide.
How similar studies have performed: Previous research suggests resistance exercise and higher protein can help preserve lean mass during weight loss, but combining these approaches with GLP-1/GIP medications like semaglutide or tirzepatide is still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 a clinically significant malignancy for less than 5 years * Any other aspect of history or condition that may limit the ability of the patient to complete the study * Having been treated with prescription drugs that promote weight loss in the last 3 months * Receiving chronic systemic glucocorticoid therapy within last month
Where this trial is running
Kuwait City
- Dasman Diabetes Institute — Kuwait City, Kuwait (Recruiting)
Study contacts
- Study coordinator: Dr Ebaa Al Ozairi
- Email: ebaa.alozairi@dasmaninstitute.org
- Phone: +965 22242999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.