Diabetes & Bariatrics Current Research

The purpose of Address 2 is to identify people newly diagnosed with type 1 diabetes who might be interested in taking part in research studies. It is an observational study, requiring one clinic visit for consent, vital signs, questionnaires and blood samples. 

The information collected from participants will be used to understand more about the development and progression of type 1 diabetes. It will also help find suitable trials of new treatments or other studies into diabetes that participants might want to take part in. When suitable trials or studies are identified the participant will be contacted to ask if they would be interested in taking part.   

To enter the study, you must have a new diagnosis of Type 1 diabetes within the last 6 months prior to enrolment and be over the age of 18.  

The target size for this study is 10,500 participants with a multi-centre geographical scope across England. 

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date: March 2026
Local Ref: 2969

Ascend Plus is a randomised, double-blind, parallel-group, placebo-controlled event driven trial designed to test the hypothesis that oral Semaglutide reduces cardiovascular events and other complications of diabetes in people with T2DM. The study will randomise approximately 20,000 people with T2DM in the UK and follow them during a scheduled treatment period with a median duration of approximately 5 years.    

Participants will be identified from centrally held routinely collected healthcare databases and invited to join the trial. There will be no physical site visits, and all interactions with participants will be conducted directly using innovative patient-centred web-based technology, supplemented by telephone, video call contact and mailed letters. Study treatment will be mailed to participants.  

Given that detailed information about tolerability, non-serious adverse events and laboratory data have been collected in previous oral Semaglutide trials, this trial will focus on collecting serious adverse events and study outcomes relevant to patients with T2DM. This will be both during the scheduled treatment period and for the subsequent 20 years’ long-term follow-up after the scheduled treatment period.  

With comprehensive data collection and large sample size, this trial expects to produce a reliable assessment of the long-term effects of adding oral Semaglutide therapy to standard of care in a broad population of people with T2DM.   

Project details: 

Principal Investigator:  Dr Kahal
Planned End Date:  
Local Ref: 5518 

For more information, please visit ASCEND PLUS – UK’s Clinical Study Registry

FORWARD 1 is a Phase 2b study to assess the efficacy, safety and tolerability of IMVT-1402 as a treatment in adult patients with Grave’s Disease.

Grave’s Disease is an autoimmune disease caused by thyroid-stimulating autoantibodies that activate the thyroid-stimulating hormone receptor (TSHR). These autoantibodies induce an increased release of thyroid hormone, resulting in hyperthyroidism. 

IMVT-1402 is currently being developed as a potential treatment for Grave’s Disease. 

This study is taking place at approximately 13 sites across the UK, and approximately 240 participants will be enrolled. 

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date:  
Local Ref: 5793

The purpose of this research study is to learn more about Nisotirostide (LY3457263), a possible new medicine for the treatment of type 2 diabetes (T2D). 

About 200 people will be in this study. 

The study aims to learn: 

• Whether Nisotirostide, in combination with Tirzepatide or Semaglutide can reduce levels of HbA1c (a test that measures your average sugar levels over the past 2 to 3 months) in participants with T2D.
• Whether Nisotirostide works better than a placebo (a placebo is an inactive or “pretend” study drug).
• What are the possible side effects of treatment with Nisotirostide. 

 The study will last for 40 weeks with regular clinic visits and blood tests whilst you are in the treatment period.  

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date:  February 2027
Local Ref: 5723 

For more information, please visit GFZD – Clinical trials.gov

Maritime 2 is a study to see if the medication Maridebart Cafraglutide (MariTide) is safe, can help to lower body weight, and can improve weight-related conditions for adults who live with obesity or are overweight, and who also have type 2 diabetes mellitus (T2DM). 

The study will look at the safety of MariTide and whether it is better than a placebo at helping to reduce body weight when used in addition to a low-calorie diet and regular exercise.  

This study is for people with diabetes who have obesity (BMI of 30 or above) or are overweight (BMI of 27 or above). 

Participants will be randomly assigned to one of 4 groups and injected with the study product or a placebo at day 1, week 2, week 4 and then once every 4 weeks for 68 weeks. The study will last for approximately 2 years.  

Project details: 

Principal Investigator: Dr Russell 
Planned End Date: August 2027 
Local Ref: 5683 

For more information, please visit MARITIME-2 Clinical Trials.gov

Redefine 1 is a Phase 3 study testing the efficacy and safety of combining Cagrilintide with Semaglutide, known as CagriSema. These medications support those with obesity or overweight to lose weight. Semaglutide is also known to help lower blood sugar levels. 

Approximately 3400 participants will take part in this study globally.

Project details:

Principal Investigator: Dr Georgina Russell

Planned End Date: October 2026

Local Ref: 5189

For more information, please visit REDEFINE 1 – Clinical Trials.gov

Redefine 3 is a phase 3 study testing a new medicine called CagriSema to see if it can be used to treat people with cardiovascular disease. Cagrilintide and Semaglutide are medicines that can help people lose weight. Semaglutide also helps lower blood sugar. CagriSema has both Cagrilintide and Semaglutide in it. 

The primary purpose of this study is to investigate the long-term cardiovascular safety of CagriSema in participants with established cardiovascular disease. The study will also investigate whether CagriSema can reduce the risk of having cardiovascular events (for example heart attack and stroke). The study will include people with overweight or obesity that may also have type 2 diabetes and/or chronic kidney disease. 

Approximately 7000 participants across the world will take part in this study. About 370 participants will take part in the UK. Study duration is expected to be up to approximately 4.5 years following randomisation of the first participant. 

Project details: 

Principal Investigator: Dr Hassan Kahal 

Planned End Date:  October 2027

Local Ref: 5480

For more information, please visit REDEFINE 3 – Clinical Trials.gov

Redefine 8 is a study looking into the long-term effect of CagriSema on weight loss in people with obesity. 

The purpose of the study is to compare the efficacy and safety of CagriSema with placebo as an adjunct to a reduced-calorie diet and increased physical activity in participants with obesity. The study will also investigate long-term maintenance of weight loss during one additional year of full dose (2.4 mg/2.4 mg) CagriSema compared with a slow tapering of CagriSema.

The 3-year treatment duration includes a 2-year main phase and 1-year open label extension phase. During the main phase, participants should be on the target dose (2.4 mg/2.4 mg) for 88 weeks, which is considered sufficient to achieve weight loss plateau and provide robust data for the assessment of weight loss, additional efficacy and safety parameters. The 1-year extension phase is designed to explore weight maintenance regimes and assess the dose reduction’s ability to maintain weight loss. 

Approximately 400 participants are expected to take part in this study. 

Project details: 

Principal Investigator: Dr Georgina Russell 

Planned End Date:  November 2028

Local Ref: 5652

For more information, please visit REDEFINE 8 – Clinical Trials.gov

Redefine 9 is a phase 3b study to see how well different doses of CagriSema help people with excess body weight lose weight. 

The purpose of the study is to investigate efficacy and tolerability of CagriSema 1.7 mg/1.7 mg and 1.0 mg/1.0 mg once-weekly as an adjunct to a reduced-calorie diet and increased physical activity, in participants with overweight or obesity. 

A maintenance dose of CagriSema 2.4 mg/2.4 mg once-weekly has been chosen for the phase 3 weight management development programme to provide maximal weight loss while ensuring safety and tolerability. However, different dosing options are needed for weight management medications to accommodate individual variations in response and tailor the treatment to everyone’s treatment goals. Lower maintenance doses may be more appropriate for patients who can reach their treatment target at a lower dose or for patients where the higher dose is not well tolerated. Overall, dosing flexibility promotes patient centricity and allows prescribers to titrate up or down, based on individual needs. 

This is a 68-week treatment period with a 6-week follow-up period. Approximately 300 participants will take part in the study. 

Project details: 

Principal Investigator: Dr Georgina Russell 

Planned End Date:  April 2026

Local Ref: 5553

Surmount is a Phase 3, international, randomized, double-blind, parallel group, event-driven study to investigate the reduction of morbidity and mortality with once weekly Tirzepatide treatment compared to placebo in adult participants living with obesity and CVD risk. 

Tirzepatide has the potential of demonstrating clinically meaningful improvements in outcomes associated with weight loss. The purpose of this study is to determine if Tirzepatide is better than placebo in reducing obesity related disease and death in adults living with obesity.  

The dose escalation treatment period is the first 24 weeks of the study. The maintenance treatment period duration depends on when the specified number of endpoint events for the final analysis occurs. If the maintenance treatment period extends beyond 264 weeks, participants will continue extended maintenance visits every 12 weeks until the study ends.  

The study will enrol approximately 15,000 participants with a 1:1 randomization ratio to placebo and Tirzepatide. 

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date: September 2027 
Local Ref: 5245 

Stratus is a randomised controlled trial studying the effects of the glucose-monitoring Freestyle Libre device. The Freestyle Libre is a flash glucose monitor and, similar to continuous glucose monitoring devices, has made glucose checks much easier with the ability to obtain a large number of glucose readings daily that is simply not possible with traditional self-monitoring of blood glucose.  

The Stratus study has 3 main aims: 

Aim 1: Study the effects of Freestyle Libre on health care contact, hospital admissions and mortality in individuals with type 2 diabetes who have suffered an episode of severe hypoglycaemia. 

Aim 2: Analyse the effects of Freestyle Libre on quality-of-Life measures in type 2 diabetes patients. 

Aim 3: Explore the role of Freestyle Libre as a substitute for laboratory HbA1c measurements. 

The study observes participants with type 2 diabetes who have been recently treated by ambulance staff for hypoglycaemia or who have attended the hospital with hypoglycaemia. It is a randomised study in which one group of participants will be returned to standard of care whilst the other group will receive regular input from a diabetes specialist over six months whilst using the Freestyle Libre device.  

The study involves 6 months active involvement (2 blood samples and regular questionnaires) followed by a further 18 months of remote review of participant’s electronic medical records. The groups will be studied to assess how many participants had significant health problems following their initial hypoglycaemia and whether there was any difference in blood tests and quality of life measures between the two groups.   

Project details: 

Principal Investigator: Dr Georgina Russell 
Planned End Date:  October 2026
Local Ref: 5307 

UK-EDI is a prospective, observational cohort study collecting bio samples and questionnaires / clinical data from individuals over 50 years of age, who are newly diagnosed with type 2 diabetes. 

Most cases of new-onset diabetes are due to lifestyle or genetic factors, but in a small subset of individuals newly diagnosed with diabetes (approximately 1 in 100 people (1%)), the diagnosis of diabetes is believed to be an early sign associated with the development of pancreatic cancer (which should be categorised as type 3c diabetes). 

The UK-EDI study will collect clinical data, quality of life data and biological samples from a large cohort of individuals with new-onset diabetes to help try to distinguish between type 2 and type 3c diabetes, identify early signs of pancreatic cancer and determine how cost-effective screening would be if it were possible. 

The study aims to have 1000 patients enrolled from across the UK. The duration of the study for each participant is 3 years, with 5 clinic appointments and one data base check at 36 months. 

Project details: 

Principal Investigator: Dr Georgina Russell 

Planned End Date: Recruiting until 30 June 2026

Local Ref: 5172

ROSIER stands for ‘Requirement for Surgical Intervention after ERCP.’ ERCP -Endoscopic Retrograde Cholangiopancreatography - is the procedure you have done to remove your gallstones from your bile duct. 

After gallstones are removed from their bile duct, some people have their gallbladder taken out and some people don’t. Usually, the surgeon decides what they think will be best for the patient. However, while surgeons use their best clinical judgement, there isn’t yet enough evidence about which treatment is best for patients. 

The ROSIER study is looking at whether it is best for patients to have their gallbladder taken out after treatment for gallstones. It is a randomised study, so those taking part will be allocated via a computer as to whether they receive gallbladder surgery or not following their ERCP. Information about the health of the participants will be collected from both the participants and their healthcare records. These results will then be compared to try and determine whether gallbladder surgery post-ERCP is the best option.   The study may take up to two years and the participants will be asked to complete questionnaires on their health every three months. The study aims to recruit a total of 1318 patients across the UK. 

Project details: 

Principal Investigator: Mr James Hopkins 

Planned End Date: August 2027 

Local Ref: 5731

For further information, please visit ROSIER – UK’s Clinical Study Registry

The profound improvement in glucose control after Roux-en-Y-gastric bypass (RYGB) has led to the recognition of the intestine as a major player in glucose regulation. The optimal length of each of the three limbs (alimentary, biliopancreatic and common) remains controversial. This is further complicated by the differences in total small intestinal length in humans (ranging between 3.5-10.5 meters).

Anatomical arrangements of RYGB results in three segments or 'limbs':

• Alimentary limb: Through which food enters the small intestine through a gastric pouch (the remnant of the stomach)
• Biliopancreatic limb: Includes the bypassed segments of the duodenum (first section of the small intestine) and proximal jejunum (second section) through which the biliopancreatic (bile acids from the gall bladder and pancreatic) secretions flow and
• Common limb: In which the food and biliopancreatic secretions mix.

Current evidence supports the hypothesis that a 'modified' RYGB with a long alimentary limb and short common limb may optimize glucose control. There have not been any clinical trials comparing 'modified' and 'standard' RYGB with glucose control as primary outcome.

In this study, we propose to recruit 80 patients with type 2 diabetes mellitus (DM) and obesity who are eligible for metabolic surgery and currently on the waiting list for bariatric surgery at North Bristol NHS Trust obesity service. Randomisation will take place intra-operatively in patients with a total small intestinal length < 5.5 meters. The surgeon will contact the randomiser who will make the allocation to either 'modified' or 'standard' RYGB before continuing with the surgery.

Participants will attend 5 visits in total (baseline, day 10, 3, 6 and 12 months post operatively) for anthropometric measurements, blood tests, urine pregnancy test, assessment of number of glucose lowering medications and adverse event profile.

Project Details
Principal Investigator: Dimitri Pournaras
Planned End Date: 01/06/2022
Local Ref: 5007

PASIPHY studies people who have had bariatric surgery at least 6 months ago and now experience low blood sugar levels after eating meals. This condition is called post-bariatric hypoglycaemia (PBH).

This is a double-blind randomised placebo-controlled dose-finding phase II study. Participants are given a study medication called Pasireotide and the purpose of the study is to see if this medication works to control blood sugar levels in people with PBH.

Participants will be given either Pasireotide or Placebo for 12 weeks as an injection. After this, participants will have the option to continue in the study for a further 36 weeks, but all participants during this second phase will be given Pasireotide.

This study will be conducted in about 36 clinical sites in 6 countries: Belgium, France, Italy, Spain, the United Kingdom and the United States. Approximately, 72 participants will participate in this study. 

Project details:

Principal Investigator: Mr Dimitri Pournaras
Planned End Date: February 2026
Local Ref: 5482
For more information, please visit: PASIPHY – Clinical Trials.gov

(Rebuilding StrEngth Together after bariatric surgery)

Reset is study aiming to understand people’s views, experiences and hopes for undertaking physical activity and strength exercise after bariatric surgery. The study involves talking to people who are on the waiting list for bariatric surgery or have undergone bariatric surgery. 

There are two phases – phase 1 involves completing a questionnaire, either online or on paper. Phase 2 involves taking part in interviews with a researcher to talk about your views and experiences in more detail. If you take part in phase 1 you do not need to take part in phase 2. 

Reset hopes to use the information from this study to plan how to offer people undergoing bariatric surgery more help with physical activity in the future. Physical activity programmes for people with obesity are not routinely offered in most NHS units at present and the Reset study aims to change this. 

This study is being conducted out of the University of Bristol alongside clinical researchers from Gloucestershire Hospitals NHS Foundation Trust. 

Project details: 

Principal Investigator: Mr Dimitri Pournaras 

Planned End Date: October 2026 

Local Ref: 5626