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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Unknown PHASE4 INTERVENTIONAL NCT05606471

Glucagon-like Peptide-1 Agonism With Very Low Calorie Diets

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The very-low calorie diet (VLCD) is a highly effective and safe way to rapidly lose significant amounts of weight and dramatically improve blood sugar control in a short period of time (typically 8-12 weeks). It has recently become recommended by the UK National Health Service as a treatment for selected patients with type 2 diabetes. One drawback of VLCD however is the associated loss of skeletal muscle which affects some patients. Semaglutide is a well-known medication for type 2 diabetes that also improves blood sugar control and facilitates weight loss. Recent research has shown that it may also stimulate muscle growth, meaning it could help to preserve muscle mass during weight loss. Therefore, this research study aims to see whether taking Semaglutide alongside the VLCD reduces the amount of muscle lost, and could improve the long-term outcomes of VLCD. The study will take place in the Medical School building in the Royal Derby Hospital. Up to 45 participants will be recruited and allocated into one of 3 groups: 1. Semaglutide only 2. VLCD only 3. Combined Semaglutide plus VLCD The study is 12 weeks in duration and consists of four visits including two 6-hour visits, one 4-hour visit and one 30-minute visit. The first visit is a short Preliminary Visit where participants are asked to ingest stable isotope drinks for measurement of muscle growth rates and muscle mass. Food intake and physical activity monitoring will also be commenced. Visits 1 \& 3 are identical and occur at the beginning and end of the 12-week intervention period, respectively. During these visits participants will undergo a Dual-energy X-ray absorptiometry (DXA) scan, a right vastus lateralis muscle ultrasound scan \& muscle biopsy, an intravenous glucose tolerance test, electromyography, tests of muscular function, gait \& balance, and questionnaires regarding quality of life \& physical activity. These visits are expected to last up to 6 hours. Visit 2 is a shorter visit mid-way through the 12 weeks, lasting approximately 4.5 hours. Participants will undergo another DXA scan and muscle biopsy in addition to having multiple blood tests taken over a 4-hour period to determine muscle protein breakdown rates. During the 12 weeks, those in the VLCD group will be asked to stick strictly to an 800 kilocalorie very-low calorie diet, whilst those in the Semaglutide group will be required to inject themselves with Semaglutide once a week. Those in the combined group will be asked to do both. All participants will be monitored closely throughout the 12-week period, with regular phone calls and/or emails.

Interventions

Name: Semaglutide Pen Injector [Ozempic]
Type: DRUG
Description: Glucagon-like peptide 1 (GLP-1) receptor agonist
Name: Very-low Calorie Diet
Type: DIETARY_SUPPLEMENT
Description: Total meal replacement with a limit of 800 kilocalories per day

Primary Outcomes

Measure: Muscle protein synthesis rate
TimeFrame: 6 weeks
Description: Measuring the rate of skeletal muscle growth in vivo by determining the rate of deuterium incorporation into muscle
Measure: Muscle protein breakdown rate
TimeFrame: 6 weeks
Description: Measuring the rate of breakdown of skeletal muscle in vivo using the rate of appearance of deuterium-labelled 3-methyl-histidine in blood after an initial oral bolus

Trial Information

NCT ID

NCT05606471

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

University of Nottingham

Last Updated

December 15, 2025