RecruitingPhase IIInterventional

Investigating and optimising physical function with weight loss

Living with overweight or obesity can make simple daily activities, like walking up stairs or carrying shopping bags, feel tiring and difficult. This clinical study, funded by the National Institute for Health and Care Research (NIHR), aims to find out how different weight loss approaches improve physical ability and general wellbeing. Participants are placed into groups testing different treatments, which may include lower-calorie diets, guided exercise, or a weight loss injection called Mounjaro (tirzepatide), compared with usual care. The study is open to adults aged 18 to 75, including people recovering from long COVID. The main trial lasts 24 weeks, with opportunities for longer follow-up. Throughout the study, NHS doctors and nurses closely monitor your health, fitness, and heart function. By taking part, you help researchers understand the best ways to help people stay active, healthy, and independent.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Leicester

Enrolment target

324

Start

29 Jan 2025

Estimated completion

01 Oct 2028

Overweight or obesity

What is this study about?

Carrying extra weight can place significant strain on the body. Everyday tasks that many take for granted—such as standing up from a low chair, lifting shopping, or playing with grandchildren—can become painful or exhausting. While doctors know that losing weight improves overall health, this study looks specifically at how weight loss restores day-to-day physical function and energy levels.

To explore this, researchers in Leicester are running a flexible clinical trial. They are testing several practical strategies, including tailored meal plans, supervised physical activity, and modern weight-loss medicines such as tirzepatide (also known as Mounjaro). By comparing these different options against standard advice, the research team wants to see which treatment gives people the greatest boost in strength and mobility.

This research is important because it looks beyond just numbers on a weighing scale. The findings could shape future NHS care, helping doctors recommend weight loss programmes that genuinely improve how people feel and move in their everyday lives.

Key takeaways

Tests how diet, exercise, and the drug Mounjaro improve day-to-day physical fitness and mobility.
Open to adults aged 18 to 75 with a BMI of 30+, or 27+ with related health conditions.
Main study lasts 24 weeks with appointments based at Leicester General Hospital.
Includes in-depth health checks, body scans, and close medical supervision.
Taking part is voluntary, parking costs are reimbursed, and you can withdraw at any point.

Who may be eligible?

You may be eligible for this study if you are an adult aged between 18 and 75 and your weight has stayed relatively stable (changing by less than 5 kg, or about 11 lbs) over the past three months. You must also be able to walk without personal help and be comfortable reading and speaking English.

The trial is open to people with a Body Mass Index (BMI) of 30 or higher. You may also be eligible if your BMI is between 27 and 30 and you have a related health condition, such as high blood pressure, high cholesterol, a history of heart conditions, elevated blood sugar, or polycystic ovary syndrome (PCOS).

There are three main groups taking part: younger adults (aged 18 to 44), middle-to-older adults (aged 45 to 75), and adults living with ongoing long COVID who have been supported by a specialist long COVID clinic.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Is your BMI 30 or above (or 27+ with an issue like high blood pressure or high cholesterol)?
Has your body weight stayed steady (within 5 kg) over the past 3 months?
Can you walk independently without assistance?
Are you able to attend appointments at Leicester General Hospital?

Answer every question to see your result.

What does participation involve?

If you take part, your initial programme will last for 24 weeks, with the option to continue for up to two years of follow-up. You will be randomly assigned by computer to either your usual care or one of the study's weight loss programmes, such as dietary changes, exercise, or weekly tirzepatide injections.

You will need to attend at least five core appointments at Leicester General Hospital. For some visits, you will be asked to fast (not eat anything overnight) so the team can take accurate blood samples. During your visits, the research team will carry out several detailed health checks.

These checks include a gentle body scan (DEXA scan) to look at your body fat and muscle, a short test wearing a comfortable breathing mask to measure your metabolism, and a small muscle biopsy. For the biopsy, a doctor will numb a small area on your leg with a local anaesthetic to take a tiny sample of muscle tissue. Your car parking costs will be refunded for all visits.

Potential risks and benefits

Taking part offers the benefit of regular, close health checks from specialist doctors, along with detailed feedback on your fitness, heart health, and body composition. If you are placed in a weight loss group, you may lose weight and feel more energetic. However, there are potential side effects to consider. Blood tests and muscle biopsies can cause temporary stinging, soreness, or bruising. Diet changes may cause short-term headaches or tiredness, while exercise can cause muscle ache. The medicine tirzepatide can cause stomach upset, nausea, loose stools, or mild irritation where you inject it. You are entirely free to withdraw from the study at any time, and doing so will never affect your standard NHS medical care.

Locations (3)

Leicester Diabetes Centre
Approximate
Leicester, England
Diabetes Research Centre
City only
Leicester, England
Loughborough University
Approximate
Loughborough, England

Common questions

What is Mounjaro (tirzepatide)?

Tirzepatide is an approved injection that helps manage weight by mimicking natural hormones that control hunger, helping you feel fuller for longer.

Do I have to pay to take part in this trial?

No, all study appointments, tests, and treatments are completely free, and your car parking costs at the hospital will be refunded.

Will I definitely receive the weight loss medication?

Not necessarily. A computer randomly selects which group you join. You might receive the medication, a diet programme, an exercise programme, or standard care.

Does the muscle biopsy hurt?

A doctor uses a local anaesthetic injection to completely numb the area first. You will feel pressure during the procedure, and your leg may feel slightly bruised or ache for a day or two afterwards.

Can I leave the study if I change my mind?

Yes. Participation is voluntary. You can stop taking part at any time without giving a reason, and your regular NHS treatment will continue as normal.

How to find out more

Melanie Davies

melanie.davies39@nhs.net +44 (0)116 258 6481 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.