NCT05606471: SemVLCD

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

Status unknown Phase 4 Last updated 4 November 2022

What this trial tests

Phase 4 trial testing Semaglutide Pen Injector [Ozempic] in Type 2 Diabetes Mellitus in Obese in 45 participants. Status unknown.

Timeline

15 September 2021

Primary endpoint
28 July 2023

28 July 2023

Quick facts

Lead sponsor	University of Nottingham
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	15 September 2021
Primary completion	28 July 2023
Estimated completion	28 July 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Semaglutide Pen Injector [Ozempic] — full drug profile →
• Very-low Calorie Diet

Conditions studied

• Type 2 Diabetes Mellitus in Obese — all drugs for Type 2 Diabetes Mellitus in Obese →

Sponsor

University of Nottingham

Who can join

Adults 18 to 75, any sex, with Type 2 Diabetes Mellitus in Obese. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Weight loss with GLP-1 medicines does not result in a disproportionate loss of muscle mass or function in obese mice and humans.
   Langer HT, Gilmore NK, Hayden CMT, Roux J, et al · · 2026 · cited 3× · PMID 41850248 · DOI 10.1016/j.xcrm.2026.102665