NCT06885736Recruiting
LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy
LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide and Tirzepatide Therapy (LEAN-PREP Study)
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 9 Mar 2025
- Start date
- 7 Aug 2025
- Primary completion date
- 30 Aug 2029
- Lead sponsor
- Dasman Diabetes Institute
- Diseases
- Obesity
- NCT number
- NCT06885736
What you commit to
- Study type: Interventional
- Planned participants: 232
- From 7 Aug 2025 to the primary completion date, 30 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Had or waiting for an organ transplant
- Having been treated with prescription drugs that promote weight loss in the last 3 months
- Receiving chronic systemic glucocorticoid therapy within last month
Other illness
- 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
- Any of the following CV conditions in last 2 months: acute MI, stroke or hospitilisation due to CHF
- History of NYHA IV CHF
- Evidence of active autoimmune abnormality that is likely to requite systemic glucocorticoid treatment in the next 12 months
- 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
Lab values
- 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
Other
- 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
- Significant uncontrolled endocrine abnormaility in the opinion of clinical investigator
Who the study is looking for
- Age \>/= 18 years
- BMI \>/= 27 kg/m2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dasman Diabetes Institute Coordinator of this site? Confirm its status | Kuwait City | Kuwait | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.