Phase 3 Type 2 Diabetes Trial, Recruiting NCT05887271 Sponsor: University of Leicester Condition: Type 2 Diabetes
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Phase 3 Type 2 Diabetes Trial, Recruiting

NCT05887271
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with a specific type of heart failure called "heart failure with preserved ejection fraction" (where the heart is still pumping adequately) by a qualified heart specialist, doctor, or heart failure nurse
  • People whose heart failure has been stable for at least 3 months, with no hospital admissions during that time
  • People living with obesity, meaning a BMI of 30 or above for those of white European background, or a BMI of 27 or above for those of Asian, Middle Eastern, or Black ethnicity
  • People aged 18 or older

Who may not be able to join:

  • People who are unable to walk or complete a 6-minute walking test
  • People who are unable to follow a structured low-calorie meal replacement programme
  • People whose heart failure is caused by certain specific heart conditions, including cardiac amyloidosis, sarcoidosis, genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy, pericardial disease, or congenital heart disease
  • People whose heart pumping function was previously very low (below 40%), unless that was caused by a rapid heart rate condition such as atrial fibrillation or atrial flutter
  • People with a known inherited, unexplained, or medication-caused form of high blood pressure in the lung arteries
  • People with severe chronic lung disease (confirmed with lung function testing)
  • People with severe disease affecting the valves of the heart
  • People with anaemia (low red blood cell levels below a certain threshold)
  • People with severely reduced kidney function
  • People who have lost more than 5kg in weight in the 3 months before joining
  • People who have had painful gallstone symptoms or gallbladder inflammation in the past 3 months
  • People with active drug or alcohol misuse
  • People who have had weight-loss (bariatric) surgery in the past 3 years
  • People with an active illness that is likely to cause changes in weight
  • Women who are pregnant or planning to become pregnant
  • People currently taking part in another clinical trial that is likely to affect their diet or weight
  • People with a history of a severe mental illness, including an eating disorder
  • People with a diagnosis of Type 1 diabetes

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Gerry P McCann, MD, University of Leicester

Phone: +44 (0)116 258 3038

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
University of Leicester
Registry
ClinicalTrials.gov
Start date
5 December 2023
Est. completion
30 June 2026

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Change in the distance walked during 6 minute walk test (6MWT)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov