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Trial · Interventional

RecruitingNot applicableRegistry data

LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy

Short name LEAN-PREP

This trial does not test a peptide that PepBank tracks.

  • Names Semaglutide, does not test it. It appears in the title.
  • Names Tirzepatide, does not test it. It appears in the title.

Overview

Status
Recruiting
Phase
Not applicable
Enrollment
232 participants (estimated)
Sponsor
Dasman Diabetes Institute · Other
Design
Randomized · Single masking
Countries
1 country

Kuwait

Start
7 Aug 2025
Primary completion
30 Aug 2029 (estimated)
Completion
31 Dec 2029 (estimated)
First posted
20 Mar 2025
Last update posted
21 Apr 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027202820292030
  1. N/A

    LEAN-PREP

    NCT06885736

    7 Aug 2025 to est. 31 Dec 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Resistance exerciseBehavioral
  • Protein IntakeDietary supplement

Arms4

  • Experimental

    Resistance exercise

    Participants assigned to the resistance exercise group will be asked to perform exercises 3 times a week for the intervention period. The first 3 sessions of the exercise will be performed under the supervision of a qualified exercise specialist to ensure that the participants are happy with the exercises and are performing them appropriately. These will also be group sessions to encourage participants to build social connections to support them during the intervention. A similar group social session will take place at week 4 and then every 4 weeks of the study to overcome any issues with the exercises and to ensure progression to an appropriate intensity.

  • Experimental

    Protein Intake

    The aim of this arm of the intervention is to ensure a protein intake of 1.6g/kg/day, as this was the intake level identified as the level after which no further effect was found on muscle mass in the meta-regression from (Morton et al., 2018). For the initial 2 weeks of the study, investigators will ask participants to consume 2 protein drinks, containing 25g protein (3g leucine), per day - one in the morning and one in the evening. At this stage, investigators won't know the magnitude of reduction of protein intake following initiation of semaglutide/tirzepatide treatment. After 2 weeks, when the first assessment of dietary intake after beginning semaglutide/tirzepatide treatment occurs, the additional protein will be based on the amount required to ensure 1.6g/kg/day with an aim to spread protein evenly across the day and aim for at least 25g protein (3g leucine) per meal or snack.

  • Experimental

    Resistance exercise + protein intake

    Participants in this arm will follow the above resistance exercise and protein intake interventions.

  • No intervention

    Control

    Participants assigned to the control group will be asked to maintain their usual exercise habits

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. MRI measured quadriceps cross sectional area (CSA)

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    At the mid-point of the thigh, investigators will measure the cross-sectional area of the quadriceps muscle and quantify muscle's thickness and size.

Secondary outcomes(20)
  1. MRI measured intramuscular fat content (total thigh)

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will quantify intramuscular fat content

  2. MRI measured liver fat

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will also assess liver fat using 3-D sequence (MR-Touch) magnetic resonance elastography (MRE

  3. MRI measured liver stiffness

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will also assess liver stiffness using an IDEAL scan.

  4. Body Composition via DEXA scan

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    fat and fat free mass via Dual Energy X-ray Absorptiometry (DEXA)

  5. Muscle strength

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Grip strength will be measured 3 times in each hand using a Jamar dynamometer.

  6. Chair rise performance

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    The number of chair rises completed in 30 seconds measured.

  7. Gait Speed

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Habitual gait speed will be measured during a 4 metre walk test

  8. Aerobic Fitness

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Aerobic fitness will be quantified with the 6 min walk test.

  9. Whole blood glycated haemoglobin (HbA1c)

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

  10. Liver function

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will measure aspartate amino transferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), albumin (ALB), total protein (TP), gamma-glutamyltransferase (GGT) and bilirubin.

  11. eGFR

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will assess kidney function by estimating the glomerular filtration rate (eGFR).

  12. Blood lipids profile

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will assess participants' lipid profiles by measuring the concentrations of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), triglycerides (TG), and total cholesterol.

  13. Fibrosis-4 (FIB-4) Index Score

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Fibrosis-4 (FIB-4) Index score will be calculated using liver function test parameters, including age, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count. The FIB-4 index is a continuous score used to estimate the degree of liver fibrosis. There is no fixed minimum or maximum value; however, higher scores indicate more advanced liver fibrosis and therefore a worse outcome.

  14. hsCRP

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

  15. Inflammatory profiles

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    investigators will assess participants' inflammatory profiles by measuring the circulating levels of interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 receptor antagonist (IL-1Ra), and tumor necrosis factor-alpha (TNF-α).

  16. Oral glucose tolerance test

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    An oral glucose tolerance test will be performed with a cannula inserted and a baseline blood sample collected, a 75g glucose load consumed and further samples collected at 15, 30, 60 90 and 120 min. Samples will be analysed for glucose and insulin levels.

  17. Physical Activity Level

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Participants will complete International Physical Activity Questionnaire (IPAQ) which measures physical activity across multiple domains (e.g., work, transport, domestic, and leisure activities). The IPAQ provides a continuous score expressed in Metabolic Equivalent of Task (MET)-minutes per week. The total score has no fixed minimum or maximum value; higher scores indicate higher levels of physical activity, and therefore represent a better outcome (greater physical activity).

  18. Sleep Quality and Disturbances

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates sleep quality and sleep disturbances over a 1-month period. The PSQI generates a global score ranging from 0 to 21, where higher scores indicate poorer sleep quality (worse outcome).

  19. Health-Related Quality of Life

    Time frame · From enrollment (at baseline) to the end of treatment at 6 months.

    Registry description

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). This standardized instrument measures health status across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a single utility index score. The EQ-5D-5L index score typically ranges from less than 0 (states worse than death) to 1 (full health), where higher scores indicate better health-related quality of life (better outcome).

  20. Baseline Dietary intake

    Time frame · Assessed at baseline (enrollment).

    Registry description

    Baseline dietary intake will be assessed using the EatWellQ8 Food Frequency Questionnaire (FFQ), a validated dietary assessment tool for the Kuwaiti population. The FFQ is used to estimate habitual dietary intake across food groups and nutrients over a defined recall period. The questionnaire generates continuous estimates of dietary intake based on reported frequency of consumption of food items and standard portion sizes (grams). There is no fixed minimum or maximum score. Higher values indicate greater consumption of the corresponding food or nutrient, with interpretation dependent on the specific dietary component being analyzed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2026

LEAN mass Preservation with Resistance Exercise and Protein during semaglutide and tirzepatide therapy (LEAN-PREP study): a protocol for a randomised controlled trial.

Alawadhi et al. 2026BMJ opencited by 4

PMID 42020128PMC13110620DOI 10.1136/bmjopen-2026-116911PUB-42020128

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2021

14 results

Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined.

Lundgren et al. 2021The New England journal of medicinecited by 417

PMID 33951361DOI 10.1056/nejmoa2028198PUB-33951361

Full text at the publisher14 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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